Clinical and Commercial Manufacturing for Oral Solid Dose in Greenville, North Carolina
Learn why this supply chain executive calls Thermo Fisher Scientific the CDMO partner of choice.
Learn how a global CDMO never loses sight of what’s important to our clients.
Learn how Amylyx Pharmaceuticals partners with Thermo Fisher Scientific to bring hope to patients with ALS.
In this webinar, Thermo Fisher Scientific’s Kaspar van den Dries and Helena Teles discuss potential mechanisms of increased absorption with lipid formulations and appropriate screening tools that are used during the development approach of these formulations. They also cover subsequent steps to scale up and industrialize these formulations. Watch the webinar to learn more.
Learn how Reneo Pharma was able to get to clinic in 14 weeks from delivery of their API.
Discover Thermo Fisher Scientific’s formulation and clinical manufacturing site in Milton Park, UK featuring proven expertise in early development and oral solid dose.
Our Brisbane, Australia site is 2014 winner of the ISPE Facility of the Year award and 2015 winner of the Frost and Sullivan APAC CMO of the year award. The site provides scale up and manufacturing services of recombinant proteins and monoclonal antibodies.
As members of the United States Air Force, Lauryn and Chris were as healthy and fit as a young couple could be. But in the world of genetics, all it takes is a couple of proteins lining up in the wrong way, and things can change in a hurry. They found that out when two of their three children tested positive for Cystic Fibrosis (CF). Lauryn and Chris were both carriers of mutations that, when combined, caused the disease. So an active life was replaced with one of endless treatments, trips to the doctor and fear of catching even the slightest cold. Plus the knowledge that life expectancy for patients with CF was typically about 31. Something no parent wants to hear. They learned of a “wonder drug” helping CF patients – one that actually treated the underlying causes of the disease, not just the symptoms. Best of all, it was manufactured in their backyard in Reading, Ohio. After about 6 months of taking the medicine, their doctor said something they hadn’t heard before: “Your daughter looks healthy.” And best of all, life expectancy for patients who respond to this therapy is now into the 60s and beyond. So these two veterans can now look forward to all the dreams that parents have for their kids, including a long life and children of their own some day.
Several Chinese pharmaceutical companies were competing to be first to market. And second place didn’t matter. Hui Wang, from Thermo Fisher’s Brisbane, Australia site, had a client trying to become the first Chinese pharmaceutical company to bring a cancer drug to the U.S. market. The complication? They’re a Chinese company who has never done business in the west. Clearly translators would have to keep things moving. But speaking both Mandarin and English wasn’t enough. With speed at a premium and a tech transfer document needed asap, Hui also needed to be fluent in the language of science. With her extensive scientific and manufacturing background, she worked with client teams, translating technical information in real time. So the process never slowed down. In fact, instead of taking the typical two months, the initial tech transfer document was ready in two weeks. Allowing her client to win that race.
A Korean client was wary of working with a global manufacturing and outsourcing partner because of perceived complications. Different departments, divisions and regions would surely create multiple teams, workflows and contracts to sort through. They believed it would be better to handle as many of the steps themselves as they possibly could. But Yoonhee knew the power of collaboration across Thermo Fisher’s Patheon and Fisher Clinical Services businesses would ensure success. While tirelessly working to ensure a seamless experience for her client, Yoonhee brought together multiple project managers into one team. From there, they coordinated the end-to-end process, from IP manufacturing through supply chain. The client saved months in the process. And now, Thermo Fisher offers one integrated program team under one umbrella CDA and MSA to save clients time and energy right from the start.
When Hurricane Maria hit the island of Puerto Rico as a Category 4 storm, it decimated everything. The entire island was knocked off the grid. No power. No fuel. No water. No food. No communications. Roads were blocked and people everywhere struggled in an environment of complete turmoil. As the General Manager of Thermo Fisher’s drug manufacturing site in Manati, Puerto Rico, Francis had a seemingly insurmountable challenge ahead of him. But with his calm demeanor, he took it one step at a time. First priority, find his people. Make sure they and their families are safe. Next, get to the site, begin the process of bringing it back. Then, establish communications by setting up a network of information distribution until cell service could return (weeks later). Give the growing list of employees managing to show up for work, despite all that was going on in their lives, more and more jobs to get the facility operational again. Keep clients informed of daily developments and goals. And most important, get the equipment up and running so that patients around the world didn’t go without their life-saving medications. Francis even opened the facility to locally-based clients on the island who needed a place to work. And finally, with the full efforts of his whole team, the facility was back online two months after the storm. It just goes to show how far you can go with commitment, teamwork and a ton of heart.
In the world of drug manufacturing not all life-saving decisions happen in the lab. Sometimes it’s a lot closer to delivery that key moments require fast thinking. Such as one Saturday morning in Memphis, TN, when Marcus noticed the freezer temperatures were out of range. With over 2,000 cold chain shipments leaving his facility per day, he couldn’t afford to lose a week’s supply due to warm temperatures. As the repair crew worked on the issue, Marcus knew it wasn’t an easy fix and he needed a backup. So he had to make a call, on a weekend, without time to consult the chain of command. Soon, Marcus had a few freezer trailers on site, and an emergency work crew helping to load ice into them, so they could keep the week’s supply safe. And on Sunday, when he got the notification that the main freezer was having issues again, he knew he had made the right call. Today, the freezer is fully operational, and such issues are rare. However, we now keep extra freezer trailers on site permanently as a back-up, just in case.
It all starts with your discovery. A molecule, small or large, that needs a partner. Let Patheon be that partner.
The pressure to file an IND makes accelerated Phase I safety testing a priority. With the Quick to Clinic program, Thermo Fisher Scientific can deliver your large molecule drug substance for First-in-Human studies in as little as 12 months. Now you can meet important milestones – such as filing the IND – or secure additional funding with all the confidence your project needs and, we can supply. Because helping you reduce the time it takes to get your discovery to the patients who need it matters, our Quick to Clinic for Biologics is made with speed and flexibility.
Whether your company is built on a single molecule or you’re a global pharmaceutical leader, you need fast, cost-effective and scientifically-based insights during early-phase development. Patheon can provide you with customized early development strategies and technical solutions to solve complex development challenges.
The challenges, risks and costs of bringing complex large molecule products to market are growing exponentially. Gaining a competitive advantage is more difficult. Drawing on 20 years of biologic experience, Thermo Fisher Scientific offers you flexible, end-to-end solutions and expertise in development and manufacturing combined with advanced technical capabilities.
Take a big picture approach to small molecules. Ensure that you always have the exact resources and expertise you need, especially for your most difficult to manufacture compounds. With Patheon you’ll have access to a vast array of small molecule API capabilities in Europe and the United States. Reactors ranging from 30 L up to 16 m3, comprehensive analytical services and expertise in all the chemistries you expect, as well as many unique solutions and innovative technologies you won’t find anywhere else. It’s a big-picture approach that delivers high-quality API via a seamlessly scalable process that will rapidly achieve your goals at each phase of development while laying a sound foundation for your future success.
Once deemed an “experts-only” approach to chemical synthesis, flow chemistry is a cost-efficient technique growing in popularity that can increase safety and flexibility and improve product quality. However, not all chemical profiles perform better under flow conditions.Download this whitepaper to learn how to evaluate whether your API will perform better with batch versus flow chemistry, as this dictates not only the process you will use for scale-up but also the facility and expertise needed to do it successfully.
The landscape of today’s drug development industry looks far different than it did only a decade ago. Innovation is creating exciting new possibilities in patient care. Improvements in synthetic chemistry and high-throughput screening have opened up the small molecule chemical space, leading to novel compounds with the desirable potency. However, they also come with greater solubility challenges. Download this whitepaper to learn why it is critical that formulation scientists use the most appropriate solubility enhancement technology and formulation strategies to improve the bioavailability of poorly soluble drugs.
When developing new pharmaceutical products, it is very important to get to Phase I clinical trial in a fast, efficient and cost-effective way. With Quick to ClinicTM for Oral Solid Dose, Thermo Fisher Scientific can deliver a drug in a phase-appropriate formulation for first-in-human studies in as little as 14 weeks from API receipt to release to clinic. This process includes one-months stability testing data to help complete regulatory submissions.
The market momentum of novel therapies targeting unmet needs is creating a new landscape for pharmaceutical drug manufacturers. As the focus on these smaller patient pools grows, so does the complexity of drug development. Companies must understand how the molecules filling today’s pipeline are changing our business, as they are causing a dramatic shift in how we plan for and execute drug development and manufacturing. As a CDMO, our customers’ needs give us a unique perspective on the evolution of the industry and how it is shaping today’s market. By passing this insight on to you, we at Patheon, part of Thermo Fisher Scientific, hope it gives you a better idea of industry trends in drug development.
Patheon, part of Thermo Fisher Scientific, is transforming the way pharmaceuticals are made with a simplified, end-to-end supply chain for pharmaceutical and biopharmaceutical companies of all sizes. Drug substances and drug products. Development and manufacturing. Small and large molecules. Sterile, oral solid and softgel dosage forms. Patheon offers a comprehensive range of services spanning all phases and scales that is wider and deeper than any other CDMO. Gain instant access to a fully integrated global facilities network.
Discover Thermo Fisher Scientific’s early development site in Bend, Oregon, featuring proven expertise in solving solubility challenges for clients.
Learn about Thermo Fisher Scientific’s expansion of its biologics site in St. Louis, Missouri. The facility will be the single largest single-use technology CDMO in the United States.
Meet the people who work with our clients at our API development and manufacturing site in Florence, South Carolina. Florence East is Patheon’s new, state-of-the-art API manufacturing facility that works on molecules from preclinical through commercialization. The team at Florence East works with batches of all sizes, from 10 kg demo runs in the pilot plant to metric tons in the commercialization facility – all at the same site.
In August 2017, Thermo Fisher Scientific completed the acquisition of Patheon, creating the world’s most comprehensive and sophisticated end-to-end CDMO partner. One year later, Thermo Fisher’s Pharma Services is delivering integrated drug development and clinical trial services to clients across the globe. In this webinar, Thermo Fisher senior executives Franco Negron and Leon Wyszkowski provide an inside view of how Pharma Services is redefining outsourced biopharmaceutical services.
Crystallization is the most common unit operation for isolation and purification of solid intermediates and active pharmaceutical ingredients (APIs). As the end point of both the chemical development process and later manufacturing, the quality of the API delivered has a direct impact upon drug product formulation development and manufacturing.
Take a look inside Thermo Fisher Scientific’s sterile fill-finish manufacturing site in Monza, Italy. The site currently manufactures commercial supply, but has recently invested $50 million in sterile drug development capabilities.
Crystallization is the most common unit operation for isolation and purification of solid intermediates and active pharmaceutical ingredients (APIs). As the end point of both the chemical development process and later manufacturing, the quality of the API delivered has a direct impact upon drug product formulation development and manufacturing.
Collaboration is an important part of our culture at Thermo Fisher Scientific and it starts with our people. Emily and Jessica are a great example of how a mentor relationship facilitates the transfer of critical knowledge to achieve long-term results. This information sharing allows us to get product into the hands of our clients faster, resulting in patients receiving their medications sooner.
At Thermo Fisher Scientific, everything we do is made with the right balance of heart and science. Find out how Angie and our Fisher Clinical Services team went above and beyond to overcome tough obstacles in order to ensure thousands of patients around the globe received life-saving medications.
Learn how Whitney took on the challenge of creating more flexibility within existing rigid processes to better meet the needs of her client. Together, they came up with a solution to optimize critical paths forward to expedite getting life-saving therapies to the patients who need them.
The stakes were high for a client who needed material for a novel drug to in order to proceed to clinical trial. With millions of dollars on the line, Jeff’s team had one shot to develop a process to scale up or risk failing the batch. They took critical steps forward to de-risk the process and solve the problem. Helping our clients hit their next milestone is why we go to work every day.
Tony and the team at Thermo Fisher Scientific understand the needs of small and emerging companies. They come to us to take advantage of our experience, expertise and global network. When every dollar counts and everything is on the line, companies put their trust in our experts to provide a solution. Tony’s “eureka moment” helped this small company make a big impact.
Meet Gavin and his mom, Nicole. Learn how Gavin’s battle with a brain tumor led him to the bottle of hope that allowed him to be a kid again. His courage and refusal to give up proved that not even a brain tumor can hold him back from his big plans for the future.
Outsourcing API development can save time and money. Or it can waste them. Since the difference between these outcomes stems from your choice of a development partner, careful consideration of these eight critical areas is required to help ensure a fast, smooth API development process.
The challenges for new drugs looking to enter the market are numerous and varied. But many are self-inflicted – especially in small molecule development. A dangerous perception persists that aside from highly potent APIs, small molecule medications have simple process requirements. The reality, however, is that most APIs will require numerous steps or significant work upfront to avoid development delays, rework or outright failure.
The biologics market is quickly evolving from a focus on developing blockbuster drugs to exploring niche markets with unmet needs. While the changes are exciting, they pose several risks to a molecule’s success as competition intensifies, timelines shorten and capacity challenges emerge. Yesterday’s solutions may not be a perfect fit for today’s molecules.
The combination of Fisher Clinical services with Patheon manufacturing brings an entirely new level of customer service to the pharmaceutical industry. Watch this video to see the clinical supply chain in action, between Patheon in Monza, Italy and Fisher Clinical in Basel, Switzerland.
As the biopharmaceutical industry continues to evolve, the Quality by Design (QbD) holistic and proactive approach to drug development and manufacturing is transforming key processes. In response to increased interest from global regulatory agencies, QbD seeks to further reduce the risk associated with drug development and bring much-needed therapies to market quicker. Sponsors who implement QbD early can save money through increased product / process knowledge, less re-work, less product deviation, less product out-of-specification, fewer rejects and improved quality.
In small pharmaceutical start-ups, you have to move fast with a limited amount of budget and resources to get your molecule to first-in-human, and then to proof-of-concept (POC). You keep headcount low and outsource wherever you can, often to multiple vendors. Working with multiple vendors means investing significant time to negotiate terms and conditions as well as to oversee the project.
“Faster and better” has become the mantra for biopharmaceutical companies as they face intense pressure to get therapies to market quicker than ever before. The incentive of securing market share with first-to-market offerings is felt by all industry players. Whether biopharmaceutical companies have one candidate or 100, the directive is clear: moving quickly into FIH testing is essential. Learn key strategies for speeding time to clinic.
There are many equally important considerations that must be balanced during early development while still ensuring a molecule’s formulation can scale successfully from early to late stage development. Over- or under-engineering a product for its stage of development is a common, costly error. Discover the criteria that pharmaceutical development teams should consider when ensuring their parenteral dosage form is prepared to scale to late stage and commercial.
There are many parenteral dosage forms from which the pharmaceutical scientist can choose to develop their drug product. For primary pack choices, there are traditional vials, ampoules, cartridges, pre-filled syringes and complex containers such as the various types of dual chamber syringes. Additionally, there are newer dosage forms such as wearable injection devices or pump patches. Each have their own merits and advantages, but these advantages may not be realized until the product is marketed. Consideration must also be made on the form of the product within the container and the environment in which it will be used and needs to be (or is able to be) stored.
Biologics have experienced steady double-digit growth over the last 15 years and now comprise slightly more than a quarter of all New Molecular Entity (NME) FDA approvals. Similarly, EvaluatePharma’s 2017 report on orphan drugs projects that by 2020, six of the 10 best-selling global drug therapies will be biologic sterile injectable drugs. Precision medicine is also on the rise, with the FDA approving a record number of precision drugs in 2017. The rise in these targeted therapies and precision medicine means big changes for drug development and manufacturing companies. Learn what pharma companies should look for when navigating this new era of small-volume manufacturing.
The numerous controls and processes in place to ensure a medication is safe, effective, and manufactured with the utmost efficiency make drug development extremely complicated. The challenges of drug development can increase if a manufacturer assumes an existing formulation for an adult can also be used for a child. Pediatric drug development requires a formulation designed to fit the specific needs of that patient population. Not considering these requirements early enough could add significant delays and costs to the development process.
Given the increasing pressure to speed up drug development and make the process more cost-effective, pharmaceutical companies want to ensure that their most promising drug candidates hit the market. However, while speed to the clinic – and then to market – is often thought to be the key to success, it is equally important that formulation, process development, scalability, and stability challenges are addressed by systematic, smart scientific solutions to de-risk the drug development process so that costly late-stage failures can be avoided.
With few potential blockbuster drugs in the pharma pipeline right now, drug companies are increasingly looking at other options to meet the needs of patients and increase revenue in the oral solid dosage (OSD) arena. Current areas of exploration include novel drug combinations, oral delivery of large molecules that were available only as injectables, and perhaps most interesting, drugs that carry digital, ingestible sensors that can send information directly to a physician.
The opioid abuse epidemic is a serious public health crisis that demands action on the part of many stakeholders. While abuse-deterrent opioids will not solve the opioid abuse epidemic alone, they play a critical role in the fight against it. While Collegium had come up with an innovative new approach to abuse deterrent formulations, it did not have the capacity or resources to manufacture its drug on a commercial scale.
Innovations in science and technology over the last few decades enable scientists to create far more advanced pharmaceuticals for today’s industry. As a result, patients rightfully expect medication with fewer side effects and physicians anticipate new and better cures for formerly untreatable diseases. Finding a balance between a complex API, its formulation, and its synthesis requires equipment, knowledge, and processes more extensive than those typically required for traditional drug development. It also calls for collaboration across several teams in order to break down the silos that can interrupt the flow of open and clear communication.
The pharmaceutical industry must constantly evolve as companies race to develop the next blockbuster drug. As they face pressure to bring new drugs to market more quickly and at minimal cost, pharmaceutical and biotechnology companies are increasingly outsourcing various parts of the drug development and manufacturing process. Outsourcing eliminates the need to maintain expensive in-house facilities while providing access to a broad range of different technologies and expertise.
An Independent Executive Research Study by ORC International examines how large molecule drug substance manufacturing and demand forecasting is riddled with complexity. The long cycle time and short shelf life of a biologic drug substance makes it difficult to adapt the supply chain with agility, even at the earliest stages of development. As a result, inaccurate demand forecasts can have significant implications for companies developing biologics. And with less industry-wide available capacity for biologic production, it is increasingly difficult to locate capacity to respond to demand changes and ensure products achieve commercial goals.
We are the first CDMO to build and manufacturing client product on a continuous manufacturing line. The suite, located at the site in Greenville, NC, is custom built to utilize the best equipment available. The cutting-edge process allows materials to flow through several small-unit operations without stopping. The result? Lower costs, reduced interbatch variability, and tighter process control.
From preclinical to clinical trial distribution to commercial manufacturing, we can help you through the entire process.
Kaspar van den Dries, Ph.D. discusses the benefits of working with Patheon for your softgels project.
Learn more about the Softgel expertise at Patheon, by Thermo Fisher Scientific.
Kaspar van den Dries, Ph.D. discusses the many advantages for drug developers who choose Softgels.
Tony van Bijleveld, Head of Softgels Business Unit discusses the benefits of the recent Thermo Fisher Scientific acquisition, as well as Softgel expertise & technology to enable innovative customer solutions for patients.
Learn more about the capabilities and expertise at our Swindon, UK site.
Learn about Patheon’s full dose form capabilities and technologies, including various tablets, caplets, chewables, powders, softgels, and more. Leverage Patheon’s broad range of expertise, from pre-formulation through commercialization, to help your project achieve success.
Your molecule has the power to change lives and shape the future. Patheon is the company that offers you the agility and speed to help you get there ahead of schedule while maintaining the highest quality. We bring deep scientific expertise to every challenge and our proven track record of scaling up biologics help ensure you gain cost and time savings at every stage of the biologic development process.
Tufts Center for the Study of Drug Development (CSDD) recently completed research, titled “Assessing the Economics of Single-Source vs. Multi-Vendor Manufacturing” that compared cycle times and development economics between multi- and single-source CDMO models. While there are many studies that debate the total cost of drug development,1-3 the Tufts study sought a better understanding of which model offered the most accelerated time-to-market for its clients. By focusing on time as a primary value driver, a sponsor can lower the overall cost of bringing its drug to market, and more importantly, achieve the speed-to-market patients both want and need.
Excerpts from the Patheon-sponsored Super Session at BIO International 2017, as Steve Lam presents, “So Many Choices: What’s the Right Biomanufacturing Strategy for Me?”
The need for new medicines for previously untreatable diseases creates new challenges for drug development. When a new lead is generated, small amounts of preclinical material are needed and produced—at any cost—to demonstrate a first proof of concept. In subsequent development phases, however, the pharmaceutical company must quickly develop an acceptable and scalable synthesis of complex new drug candidates to meet accelerating timelines and rapidly move the molecule through clinical development.
Patheon’s Jennifer Therrien discusses findings of a Tufts Center for the Study of Drug Development (CSDD) study that reveals how pharmaceutical companies using a single-source outsourcing partner can achieve a net gain of $45 million in early drug development.
Michel Lagarde, President of Pharma Services, Thermo Fisher Scientific, discusses why Pharma Services employees are so passionate about partnering with small and emerging biopharma clients.
Leon Wyszkowski, President of the Clinical Trials Division of Thermo Fisher Scientific, discusses the value of Patheon and Fisher Clinical Services joining together to provide integrated solutions for our clients.
Video Webinar with The Medicine Maker, Chapter 1: Understanding Industry Shifts
Video Webinar with The Medicine Maker, Chapter 2: Overcoming Commercial Launch Challenges
Video Webinar with The Medicine Maker, Chapter 3: Identifying Volatile Forecast Variables
Video Webinar with The Medicine Maker, Chapter 4: Measuring Forecast Accuracy
Video Webinar with The Medicine Maker, Chapter 5: Planning for Insourcing or Outsourcing
Video Webinar with The Medicine Maker, Chapter 6: Leading Industry Transformation
Traditionally, the development of a small-scale synthesis for an active pharmaceutical ingredient (API) and its scale-up to meet the materials demand for clinical trial phases is a sequential activity that passes through multiple sets of hands. Even if the synthesis used at a small scale is the same one used at a large scale, the developer must be prepared to encounter and react to any changes to the API’s quality attributes, such as by-product profile and physical form. Learn why a company must be aware of any potential conditions that could occur at a small-scale that could create major issues during commercial scale-up.
Pacira Pharmaceuticals is working to curb the opioid epidemic with its injectable suspension, EXPAREL®. EXPAREL is produced at Patheon’s Swindon facility, creating a strategic partnership between the two companies.
The pharmaceutical development of a product can be a difficult journey to navigate with lots of ups and downs along the way. Many challenges can arise that pose a risk to timelines, cost, and clinical success. View this webcast to hear experts evaluate how pharmaceutical development teams can balance development needs and mitigate risks by applying phase-appropriate, science-driven formulation and design principles.
Biopharma executives face a daunting number of decisions daily as they address the challenges of bringing drugs—which may be unstable and unpredictable—to market. Perhaps the most important decision is selecting the biomanufacturing strategy that is the best fit for their organization.
When aggressive timelines are a “must,” it’s critical that companies don’t gloss over early-phase scale-up throughout the development process. The time and effort spent on risk assessments and thinking about scalability early on will pay dividends in the long run as the path toward regulatory approval is smoother.
In drug development, designing a formulation for a drug product (a tablet, for example) calls for careful attention to both the physical and chemical properties of the active pharmaceutical ingredient (API or drug substance). It also requires awareness that certain physical attributes, such as particle size distribution of the drug substance, can change with processing conditions and changes in the synthesis route that is employed. Find out how a pharmaceutical company can recognize both unfavorable drug substance properties and incompatibility between an API and its formulation to avoid potential risks to the patient as well as costly interruptions during development.
Changes in the Drug Substance (DS) process as it scales up can affect the Drug Product (DP). As processes change, many properties of the DS can also change. Therefore, as DS manufacturers evaluate and optimize the synthetic route, process conditions, crystallization solvents, etc., they must understand and track these changes, and discuss them with DP formulators to anticipate challenges in formulation.
In 2016, Patheon successfully completed 111 technology transfers to help our clients safeguard supply, improve distribution and reduce program costs and risks. This has allowed firms to take advantage of specialist expertise, solid processes and standardized operating procedures and equipment.
The traditional business model for in-house pharmaceutical manufacturing is nearly a thing of the past. More companies are turning to outsourcing to achieve flexibility and efficiency in a highly competitive market.
Regardless of whether your group has been diligently planning for scale-up since Phase I or you have delayed scale-up work until now, it would be a mistake to assume Phase III will be clear sailing. The reality is that several manufacturability problems could be brewing that will rain down during Phase III and cause costly delays, no matter how skilled the product and process development teams may be.
As part of the FDA’s efforts to address opioid addiction, the agency put an opioid action plan into effect in 2011 to “reduce opioid abuse, dependence, and overdose in the United States.” Part of this plan included a call to pharmaceutical manufacturers to develop and expand access to abuse-deterrent formulations (ADFs) in order to discourage abuse among patients and promote innovation in the industry.
The pharmaceutical industry’s past reliance on blockbuster drugs has evolved to include a focus on developing drugs that treat the unmet needs of smaller patient populations. These niche drugs most often come in the form of biologics, which are an increasingly larger share of new drug approvals in the past decade, from a low of 10 percent to a high of 27 percent. By 2022, 50% of the value of the top 100 products is expected to come from biologics.
When a biologics company prepares to launch a new product, it must forecast the manufacturing capacity it will need. To create this forecast, it must factor in its estimate of the size of future sales, the timing of the launch, the dosage of the product, its strategy for building its market and a host of other variables. Variations in any one of those factors can lead to drastically different demand scenarios. If a company overestimates demand, it may end up investing in too much capacity, and therefore find itself paying more per unit of the product than it needs to, thus impacting its margins. If it underestimates demand, it risks not being able to satisfy demand, therefore losing revenue. Forecasting demand is a complex endeavor. For instance, it’s not unusual for the forecasted and actual dosage of a product to vary by a factor of as much as three. Obviously, that makes a big difference to a demand forecast. If a manufacturer has built capacity in anticipation of a new product and its clinical trial is delayed (for any number of reasons), that manufacturer’s capital is tied up in a fallow facility. For a small company for which liquidity is critical, that can be catastrophic.
The road to take a drug compound from discovery to commercialization is long, expensive and often fraught with unforeseen challenges. While every project will undoubtedly face some bumps along its path, far too many programs hit insurmountable obstacles that require innovators to backtrack and correct their course before proceeding, further extending timelines and adding costs.
Formulation problems are arising with greater frequency, delaying development, and burdening developers with unanticipated and heavy costs. Identifying the critical attributes of the API and having a full understanding of the impact of these on the drug product manufacturing and scale up is the key to anticipate problems and address them early. Adapting the API manufacturing process and an early systematic characterization could prepare the drug developers to solve problems earlier in the program.
View Patheon’s short video webinar, “How adaptable manufacturing models are paving a steady path into an unpredictable future,” hosted by Rich Whitworth from The Medicine Maker. In this webinar, Rich sits down to discuss real-world implementations of adaptable manufacturing models with Patheon’s Joe Principe, Vice President of Strategic Partnerships, and Pacira’s Steve McCairns, Executive Director of UK Operations.
As drug companies have fewer and fewer new compounds entering their R&D pipelines, outsourcing of development and manufacturing activities for oral solid dosage forms and sterile forms is on the rise. Pharmaceutical Technology recently spoke with Anil Kane, PhD, MBA, executive director and global head of technical and scientific affairs at Patheon, about trends and significant changes in outsourcing the manufacture and development of solid oral dosage forms.
Join Paul Jorjorian for a 20 minute “Ask the Expert” webcast with BioProcess International. During the webcast, Paul reviews how biopharmaceutical companies are facing increasing constraints when developing and manufacturing their large molecule drugs and how, as a result, selection of the right biomanufacturing partner is critical.
ORC International’s report “Implications of Inaccurate Forecasting on Biologics Drug Substance Manufacturing” explores the causes, consequences, and potential solutions to forecasting challenges specifically related to biopharmaceutical drug substance manufacturing. This analysis provides further insight and perspective on the key themes that emerge from the report and offers additional solutions to companies to better prepare for the inevitable forecast inaccuracies for biopharmaceuticals.
Consultants play a critical role in ensuring the long-term success of small biopharmaceutical companies, though much of their work happens behind the scenes. From lifecycle planning to marketing advice, consultants help fill gaps in knowledge while having their fingers on the pulse of new production strategies that might be a fit for clients. Counseling clients on such solutions—especially those that may help to de-risk the increasingly challenging biopharmaceutical development process—can be a win-win for the industry and consumers alike. What follows is a guide to some key strategies that consultants can keep in mind for their smaller biopharmaceutical clients.
Drug development is an expensive proposition. Discovery and preclinical work are estimated to cost $318 million per compound, with an additional $800 million to $1.1 billion required to advance a molecule from first-in-human testing to market approval. For small biopharmaceutical innovators, steep development costs are compounded by the fact that large molecules are becoming increasingly complex and serious clinical or manufacturing problems may not surface until late in the process. Building upon this risk, events such as mergers, acquisitions, restructurings, political uncertainty and even public criticism can all have a huge effect on a small company’s stock and monetary resources. With a limited amount of money at their disposal for generating clinical data, biopharma firms are often waiting for the perfect moment to pull the trigger and move products quickly through development. This creates a situation where highly compressed process development timelines lead companies to overlook critical factors that could delay— or even suspend—efforts down the road. In this whitepaper, we identify some important risks that consultants should put on the radars of their small biopharma clients. Doing so, along with choosing the right outsourcing partner, will ensure their risks—not their financial returns—are diminished.
ORC International’s 2016 study highlights issues inherent in forecasting biologic drug substances. From discussions with pharmaceutical and biotechnology industry leaders, it is clear that demand forecasting is a significant challenge when planning biologic drug substance production. The biologics development and approval process is typically long and complicated, increasing the risk of accurately forecasting demand. Overestimating demand can lead to higher per unit cost and disposal expenses, and underestimating it can result in missed market opportunities and negative reputational consequences for the company. Download and read Patheon’s perspective to the ORC study “Challenges, Risks and Strategies for Biologic Substance Manufacturing” and discover how biologics companies are increasingly demanding modular and disposable technologies and continuous manufacturing because of the need for flexible capacity.
We live in a time when breakthrough medicines are being discovered at an unprecedented rate. Yet whether from big pharmaceutical companies or small hubs of innovation, these treatments of tomorrow are often held up by a complex supply chain. Patheon offers a cure.
Formulation problems are arising with greater frequency, delaying development, and burdening developers with unanticipated and heavy costs. Find out how to best anticipate formulation challenges of complex molecules and APIs.
Take months off the development timelines of your large and small molecule discoveries. With Quick to Care™ you can combine your drug substance and drug product development, demand planning and clinical trial supply execution into a single customized solution to simplify your supply chain and accelerate your discovery through clinical development. You’ll be able to develop small molecules 8–12 weeks faster than the industry-standard 15 months, and large molecules 14–20 weeks faster. And the advantages don’t end there…
Pharmaceutical companies walk a tightrope in early drug development. They have to balance speed, quality, scientific risk, and API cost. Compromising on any one of these four crucial elements can prove fatal to a product candidate. Appropriate use of sound science applied at critical junctures will improve efficiency in the high-wire act of drug development.
Pharmaceutical companies around the world are under tremendous pressure – from regulators, legislators, payers, and patients – to reduce the cost of drugs. In response to the outcry for cost-cutting, pharmaceutical company leaders are examining every aspect of their business to determine where they can derive savings, particularly when planning for the launch of a new product.
Biopharmaceutical companies take on a lot of risk developing new large molecule drugs. With more complex molecules in development, changing capacity needs, uncertain forecasts and increased competition, the market demands flexibility and innovative approaches to address today’s new challenges.
Opportunities to transform an industry are rare, but often they develop from unexpected sources. Long considered an essential yet largely commodity-output business, biopharmaceutical supply chain management may emerge as a hidden transformational force for the industry.
We know the cost of developing a prescription drug is estimated at $2.6 billion, and takes 10 to 15 years from target selection to drug approval with an overall success rate around 10%. Furthermore, only about 35% of drug discovery projects succeed in delivering experimental drugs ready for clinical testing.
Nearly 75% of drugs in development have solubility challenges which often leads to failure in clinical trials. Fortunately, by addressing solubility earlier in a development program, timelines can be shortened and risks can be mitigated. By analyzing the physical and chemical characteristics of a given drug through molecular modeling, a rational selection of the most promising solubility enhancement technologies, including amorphous dispersion (AD) formulations, can be achieved before any experimental work is performed.
Poorly managed postoperative pain can have a significant impact on a patient’s recovery. Consequently, more patients relying in opioids furthers compounds the opioid epidemic. This case study discusses how Patheon and Pacira Pharma partnered to help curb this epidemic.
When pharmaceutical companies introduce a new drug to market, they invest enormous amounts of capital, and assume equally enormous amounts of risk. As it usually takes three-to-four years to prepare manufacturing capacity for the large scale production of a new product, the decision as to how much volume a company will need often must be made before Phase III trials are completed. At that point, it is difficult for developers to forecast demand. Therefore, deciding how much manufacturing capacity they will need is problematic, to say the least. Underestimating or overestimating demand can have a devastating impact on the bottom line.
In this webinar, experts will explain the benefits of considering lipid formulation early in the development process and how a structured screening and development approach can assist in overcoming potential barriers associated with lipid formulations.
In today’s drug manufacturing environment, demand forecasts provide critical input that ultimately affects pharmaceutical companies’ decision-making processes. Pharmaceutical companies utilize drug forecasts to design clinical programs, position sales force resources, allocate geographic resource distribution, and obtain company or licensing assets. However, achieving accurate forecasts is extremely challenging, especially for new drug launches.
When planning for the commercialization of a new product, pharmaceutical manufacturing executives must plan for capacity needs very early in the process. Download this whitepaper to learn about key variables that manufacturing executives should consider when evaluating flexible manufacturing solutions for commercial manufacturing projects.
The Biopharmaceutics Classification System (BCS), developed by the U.S. Food and Drug Administration to simplify and accelerate the drug development process, helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.The objective of the BCS system is to predict in vivo performance of drugs from in vitro measurements of solubility and permeability. The system has evolved to classify low-soluble drugs according to their permeability (BCS Class II or IV). A compound’s classification (I through IV) is indicative of its potential bioavailability.
What’s the best path for your low soluble molecule? Two molecules, both designed to treat the same condition, both with solubility challenges. Two biopharma companies racing to be first. Biopharma A chooses to move into trials as quickly as possible, while Biopharma B decides to address broader solubility concerns first. Who gets to market first may surprise you.
As the need for more targeted drug therapies has increased and drug development has become more complex, the industry has seen a corresponding rise in the number of molecules with low solubility challenges. In fact, up to 90% of today’s drug candidates are plagued with low solubility. In light of this challenge, drug formulators must look to new techniques and formulation technologies to proactively address low solubility challenges and ensure effective treatments are reaching patients in need.
Patheon Solubility Enhancement Services approaches BCS II drug substance solubility issues a fundamentally different way. By evaluating your molecule’s physiochemical characteristics in advance, we identify the solubility enhancement technologies most likely to work, before any work is done. That helps eliminate rework and worry later on — and saves you time and money.
Oral Solids. Access a remarkable range of conventional and specialized oral solid dosage form capabilities and scale. Further expand your options with innovative combinations of these forms and a variety of controlled-release technologies.
Phase I clinical materials in as little as 12 weeks. Only twelve weeks from receipt of your API, Patheon Quick to Clinic™ can deliver bulk clinical trial materials for first-in-human studies. That includes a one-month stability study so you have all the data you need to make informed proof of concept decisions and complete regulatory submissions. What’s more, this accelerated program gives you the choice of five dosage forms. In the pharmaceuticals industry, speed is important but consistent high quality is a must. Your project will be carefully monitored by our global quality management system. This will ensure that each and every dose is equally compliant, safe and effective.
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