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Reduce Your Risk Instead of Your Return

Tom Sellig

August 10, 2016

3 Min Read

Patheon_FLEX_Logo_wGray_RGB-300x38.jpgBiopharmaceutical companies face a broad range of challenges when developing new large-molecule products, including

  • Potential failures in the clinic or, even worse, an inability to manufacture because of an increase in the number of complex molecules in a company’s pipeline

  • Under- or over-manufacture of a drug substance raw material because of demand uncertainty

  • Limited access to right-sized capacity, driven by the bioprocess industry’s shift away from large-volume stainless steel tanks toward mid-scale bioreactors

  • A company’s inability to find a manufacturing slot for its trial or product launch, given capacity limitations within contract development and manufacturing organizations (CDMOs) and biopharmaceutical organizations

  • Missing first-to-market position as a result of increased competition.

Flexible Biomanufacturing
Patheon flexible biomanufacturing solutions offer a unique combination of expertise in development and manufacturing with advanced technological capabilities, innovative approaches, and flexible business models that can overcome challenges and reduce your risk.

Perfusion Processing: Our expertise in mid-scale perfusion techniques allows for higher yields from low-titer cell lines as well as manufacturing of recombinant proteins with stability challenges, which result in higher product volumes at any given reactor size.

Single Use or Flexible Stainless Steel: Single-use technology allows for faster, more efficient technology transfers; eliminates cross-contamination concerns; and simplifies management of your supplier relationship by streamlining your process. For processes that require stainless steel systems, our experienced staff achieves a 95% success rate to ensure 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 manufacture simplifies the supply chain and enhances quality control by eliminating potential hand-off issues. You can achieve a stronger CMC filing and time savings of 14–20 weeks.

Global Network: Our global footprint offers a range 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 traditional capacity, Patheon offers five biologics manufacturing models that can be customized to match your unique program needs.

Dedicated Capacity: For companies that have two or more products with similar bioprocessing requirements, launching within 18 months, and needing a dedicated facility or line, dedicated capacity allows for modifications to manufacturing schedules until you know the exact demand for each product. Within a dedicated facility, you can allocate capacity for each product and transfer technology in and out of the line without additional fees.

Fractional Ownership: For companies that don’t have the budget (or the volume) for a dedicated facility or manufacturing line, Patheon can build a single CMO facility or a line for two or three clients, providing flexible capacity for each. This model is less expensive than a 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 ensures you anytime access (within a specified period) to a specific type of capacity within Patheon’s global network. You can adjust the product mix with the assurance that you will have the right type of capacity when you need it.

Condominium Capacity: This is a fully customized solution for a new product that cannot be manufactured on a conventional manufacturing line. Patheon provides design services, works with equipment suppliers, validates a process, builds a line, and manages operations on your behalf. Overhead is shared, and the line can operate as needed to meet demand.

Enterprise: 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. Patheon can manage these facilities to accomplish those goals, allowing you to focus on your core competencies.

Tom Sellig is senior vice president of sales at Patheon; 1-919-220-3200; [email protected].

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