Biopharmaceutical outsourcing has changed over the years. In this Featured Report the authors explore the increasing complexities of devising long-term business strategies, the importance of choosing between long-term partnerships or one-time/transaction-based projects; the assurance that adequate business support and technical capabilities exist on both sides of the relationships; and the criticality of navigating the uncertainties of working with different quality organizations. Issues that affect decisions to outsource include cost, converging quality systems, change management, and staff training/expertise (including statistical capabilities).
Outsourcing Manufacturing and Analytical Needs in the Biopharmaceutical Industry
S. Anne Montgomery, with Jeff Staecker
BPI’s editor in chief spoke with Jeff Staecker, principal consultant at BioPhia, about his view of current outsourcing trends. Those identified in this discussion set the stage for the articles that follow. Issues that affect decisions to outsource include cost, converging quality systems, change management, and staff training/expertise (including statistical capabilities).
Accelerated Development Through Strategic Analytical Partnerships
Michael Merges and Brian Fahie
The author notes that most outsourcing business drivers have been reactive, functional, or financial in nature. For example, a merger might drive installation of a new sourcing model (reactive). A small company may not have good laboratory or manufacturing practice (GLP, GMP) capabilities for supporting clinical trials, drug stability, or manufacturing (functional). Those approaches are appropriate for short-term needs, but they are inefficient and ineffective for long-term success and profitability. His case study presents implementation by his company’s technical development analytical team of a four-quadrant strategic sourcing model developed at Biogen.
Outsourcing Biosimilar Development
Cassidy Cantin and Kristi Sarno
Biosimilar companies are working at a feverish pace to develop the next generation of follow-on products. Outsourcing to a growing group of contract development and manufacturing organizations (CDMOs) is a key strategy for savvy developers to accelerate their products’ launch. Cost and capabilities continue to be key factors used to differentiate competitors in a crowded market, but biosimilar companies face a number of unique strategic challenges that must be considered as well. The authors interviewed companies that are sponsoring biosimilar candidates and CDMOs that manufacture such products to identify some challenges and find out how CDMOs are adapting to capture this portion of the biopharmaceutical market.
Specialized Outsourcing Services: Antibody–Drug Conjugates
Managing only the conjugation part of an antibody–drug conjugate (ADC) project can be a challenge in and of itself. So considering all the component parts of an ADC, it is understandable why so many related activities may need to be outsourced. The author offers guidelines for assessing a CMO/CDMO’s relevant development expertise, technological understanding, ability to integrate key groups/sites, flexibility in response to issues arising in clinical trials or in shipment of raw materials, and competitive pricing.
Critical Aspects of Technology Transfer to CMOs
Technology transfer to contract pharmaceutical manufacturers demands knowledge, transparency, trust, competence, and structured data when appropriate. No matter how thorough or transparent is the transfer of knowledge, what separates merely adequate CMOs from the cream of the crop is adaptability and versatility in the face of adverse events and the ability to translate lessons learned to efficient execution of complex projects. The author looks at elements of modern technology transfer approaches, conducting gap analyses, addressing potential pitfalls, and managing risks.