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Consultants' Guide to Flexible Biomanufacturing Solutions

As a pharmaceutical consultant, you are an invaluable contributor to the long-term success of small biopharmaceutical companies. Since your clients often operate with small staffs focused on discovery, your expertise as a consultant is essential in filling gaps in manufacturing and regulatory knowledge as well as helping to navigate the complexities of development and commercialization.

In this way, you are a vital resource for helping your clients carefully evaluate and access the manufacturing solutions that underpin a compound's success. Matching a CDMO's capabilities to your client's project, timeline and budget is far more complex than simply fitting machinery. Your network is a valuable resource for identifying a trusted manufacturing partner that offers comprehensive and flexible service options that support production success.

Together with a flexible solution provider like Patheon, you can provide guidance for helping small companies bring life-improving, life-saving drugs to patients in need.

Custom, Flexible Solutions That Cater to the Needs of Small Biopharma

Patheon's Flexible Biomanufacturing Solutions help small biopharmaceutical companies mitigate unnecessary risks in the drug development and commercialization process. We balance the pressure for speed to market with the need to build a streamlined and robust process that is scalable from early to late-stage development and bolstered by the CMC data that regulators require. We offer a development roadmap that provides a comprehensive analysis of the work that is needed upfront. Patheon routinely collaborates with consultants to adjust services to meet clients' needs while reducing the risk of late-stage failure and maximizing financial returns.



Flexible Strategies

Flexible Strategies

To de-risk supply forecasts while saving time and money during process scale-up, flexible options like multiplexing enable firms to easily add capacity without revalidation. Patheon offers several options and approaches that ensure the needs of each client are met. Clients can leverage our single-use systems, which offer greater flexibility and potential cost savings.

Upstream Harvesting, Including Perfusion

Upstream Harvesting, Including Perfusion

Our in-house capabilities enable us to offer a cell-culture platform that best fits your clients’ projects, be it perfusion, high-density fed batch or another format. This flexibility helps ensure a better cost-of-good metric for diverse projects. Patheon has unique solutions in mid-scale perfusion techniques that provide for higher yields from low-titer cell lines, which may be suitable for cells with stability challenges. Perfusion processing also makes it possible to increase yield at a lower production scale, which has a positive cost-of-goods impact for your customers.

Streamlined Technology Transfer

Streamlined Technology Transfer

Not only is tech transfer at Patheon fast and efficient, but your clients can also take advantage of our expertise during this process to elevate projects to the next level—even those in mid-phase. We employ cutting-edge manufacturing techniques that build increased efficiency and strategic advantages into process development as well as simplify supplier relationships. Our team of CMC experts can also design a strategy for filling gaps in data.

Simplified Supply Chain

Simplified Supply Chain

A typical multi-vendor development plan might have as many as 10 different potential sources of time and cost inefficiencies. Bringing multiple vendors—including raw material vendors, manufacturing experts, packaging suppliers and others—under the same roof and accessing a common project management structure through Patheon OneSourceTM creates a more efficient system with cost and timeline advantages. Our integrated drug substance and drug product services shave 14–20 weeks off development timelines for large molecules.

Global Network

Global Network

With manufacturing sites located around the globe, we can ensure your clients’ projects are assigned to a facility with specialized equipment and knowledgeable staff that are well-suited to your product and keep projects on the path to success.

Technical and Regulatory Expertise

Technical and Regulatory Expertise

With solutions for early-stage development through commercialization, we give your clients access to a large pool of experts who can guide every step of a product’s lifecycle. This technical and regulatory knowledge is especially critical for ensuring the necessary data is collected for successful regulatory filings.

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