For many pharmaceutical companies that do not have their own facilities, choosing the right partner for late-phase clinical trials and commercial production is a critical aspect in the management of parenteral products. Oftentimes, small contract development and manufacturing organizations (CDMOs) can provide early-phase clinical material but do not have the ability to move through late stage and into commercialization. This webcast will offer an insight into the importance of looking for a partner with extensive experience in the parenteral arena, as products move through clinical phases and toward commercialization. Learn how the right partner should be able to manage programs at all clinical stages, as well as have the ability and expertise in moving compounds from early-to late-clinical stage and through the process validation process to commercial launch.
Learn the Process Characterization basics, including if it’s a requirement or if optional, and more! Greg Sears, Ph.D, Global Director, Process Characterization, Head of Manufacturing Science and Technology, Pharma Services, Biologics at Thermo Fisher Scientific, focuses on: Why is Process characterization important What does “good” process characterization look like Impact of process characterization and process validation/PPQ campaigns Review available choices and the risks/rewards Learn how to speed up the process
Pharmaceutical developers are under pressure to rapidly advance products to the next clinical milestone. In early development, decisions are made regarding how much should be invested in API process development, characterization, and other parts of the workflow. Not making the right decisions can lead to challenges with drug-product formulation and even clinical data.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.