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Flexible Biomanufacturing Solutions
Biopharmaceutical companies are facing more and more challenges when developing new large molecule products. There are an increasing number of complex molecules in the biologic pipeline as therapeutic targets narrow to orphan indications and specialized medicines. And with the market growing double the rate of the small molecule market, there are increasing numbers of biologics competing to be first to market for these smaller therapeutic populations. Advances in bioprocesses and capabilities, along with the focus on smaller, niche populations, has led to a shift in the types of capacity the market demands. These challenges are only compounded by inaccuracies in product forecasting. There is a solution: Flexible Biomanufacturing Solutions. We also recognize that pharmaceutical consultants are an invaluable contributor to the long-term success of small biopharmaceutical companies. We will partner with you to offer flexible biomanufacturing solutions that cater to your clients’ needs.
Top Experts’ Advice for Mid-Size BioPharma
Challenges in the Biopharmaceutical Industry and Inaccurate Demand Forecasts
Insights on biologics drug substance manufacturing and the regulatory approval process
Biomanufacturing Strategies and Regulations Governing the Industry
Advice for Mid-Size Biopharma on Biomanufacturing Challenges and Strategies for Success
Fed-Batch vs Perfusion Processing Debate with BioPharm International
Insights on Fed-batch vs Perfusion Processing and Upstream vs Downstream Process Improvements
Recommendations on Biologics Drug Substance Manufacturing and Fed-Batch vs Perfusion Processing
Challenges for Today’s Biopharmaceutical Organizations and the Impact of Inaccurate Forecasting
Thermo Fisher Scientific’s Flexible Biomanufacturing Solutions help biopharmaceutical companies manage these challenges and resulting risks. We combine expertise in development and manufacturing with advanced technological capabilities, innovative approaches and business models to overcome development hurdles and speed-to-market.
Our expertise in mid-scale perfusion techniques allows for higher yields from low-titer cell lines and the manufacture of recombinant proteins with stability challenges. This results in a higher volume of product at any given reactor size, as well as the manufacture of complex proteins.
Single Use or Flexible Stainless Steel
Single Use Technology allows for faster, more efficient tech transfers, eliminates cross contamination concerns and simplifies management of your supplier relationship. For processes that require Stainless Steel, our experienced staff achieves a 95% success rate so you can be confident in quality results no matter which method you require.
Integrated Drug Substance and Drug Product Services
Our ability to take your large molecule project from development through commercial simplifies the supply chain and enhances quality control by eliminating potential hand-off issues. You can see stronger CMC filing and time savings of 14-20 weeks.
Our global footprint offers a variety of benefits from simplified logistics to secondary supplier sources to R&D tax credits. Simply put, our scale works to your scale-up advantage.
Flexible Business Models
In addition to the traditional capacity approach, Patheon, by Thermo Fisher Scientific, offers five flexible biologics manufacturing models. These five options are points on a spectrum. Patheon can customize any solution to match your unique program needs.
Companies that have two or more products with similar bioprocessing requirements, launching within 18 months, need a dedicated facility, or line, so they can modify their manufacturing schedule until they can understand the exact market demand for each product. Within the dedicated facility, a client can determine how much is used for each product and can transfer technology in and out of the line without additional fees.
For companies that don’t have the budget (or the volume) for a dedicated facility or manufacturing line, we build a single CMO facility or line for two or three clients, providing flexible capacity for each. This model is less expensive than the dedicated line but still provides flexibility and scalability.
Flexible Network Access
For regulatory purposes, global companies often need manufacturing capabilities in both North America and Europe. Or they simply may want on-demand access to capacity without preference for location. Flexible Network Access assures the client anytime access (within a specified period) to a specific type of capacity within our global network. Clients can adjust the product mix with the assurance they will have the right type of capacity when they need it.
This is a fully customized solution for a company introducing a new product with unique characteristics (for example, unique product types or platforms) that cannot be manufactured on a conventional manufacturing line. We provide design services, works with equipment suppliers, validates the process, builds the line, and manages operations on behalf of the client. Overhead is shared, and the line can operate as needed to meet demand.
This is a solution for companies that own facilities in need of operational improvements. Some facilities may need to repurpose existing equipment; some should be closed. Our experts will then manage these facilities to accomplish these goals, allowing our clients to focus on their core competencies.
Download our whitepaper, “Is Your In-House Strategy Ready For The Uncertainties Of Biologic Drug Development?”