Regulatory Beat: New Policies Seek to Spur Biopharmaceutical Development - FDA is working to bring new therapies to market while also modernizing manufacturing processes to assure product quality. - B

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Regulatory Beat: New Policies Seek to Spur Biopharmaceutical Development
FDA is working to bring new therapies to market while also modernizing manufacturing processes to assure product quality.


BioPharm International



Jill Wechsler
Last year's catastrophic flu vaccine shortage and escalating Congressional debate over drug safety continue to shine the spotlight on biotech product manufacturing. FDA officials are under pressure to address concerns about access to quality biotech products, while also encouraging the development of new treatments to meet patient needs. Meanwhile, Congress is weighing incentives for developing new counter-bioterrorism treatments (see sidebar).

While the design of clinical and pre-clinical studies absorbs considerable attention in the biomedical research world, manufacturing science has emerged as a critical element in moving products from clinical testing to commercial scale-up. Ensuring access to consistently high-quality biotech therapies, vaccines, and blood products is the focus of efforts by the Center for Biological Evaluation and Research (CBER) to spur new product development. This topic was explored at a CBER workshop last October (2004) on opportunities for collaboration with industry and other stakeholders under FDA's "Critical Path" initiative.

MORE ASSISTANCE To ensure that early studies will lead to quality products, CBER officials are emphasizing the value of discussing critical manufacturing issues with sponsors early in the clinical development process. CBER's Office of Compliance and Biologics Quality (OCBQ), now headed by Mary Anne Malarkey, is encouraging this approach, especially for companies considering novel methods for scale-up, product sampling, manufacturing process control, or compliance with good manufacturing practices (GMPs). Meetings to address topics such as appropriate containers and shipping is particularly critical for cellular and gene therapies. Despite ever-tightening resources, OCBQ is offering decision-making assistance on raw material selection, sampling techniques, product shipping, technology transfer, manufacturing scale-up and automation, and other key activities.


Incentives for Countermeasures
"WISH-LIST" ITEMS Increased interaction with manufacturers not only will help industry achieve high quality manufacturing on a consistent basis, but also may assist CBER in evaluating its regulatory process and identifying opportunities for collaborative science to promote innovation. In recent years, CBER research programs have supported the development of new methods for conjugate vaccine synthesis, prion inactivation and testing, and standards for influenza seed strains.

At the Food and Drug Law Institute (FDLI) annual meeting in April, CBER director Jesse Goodman described continuing efforts to gain manufacturer input in setting priorities for cross-cutting collaborative research that could develop:

  • well-characterized cell banks and new safety assays for vaccine and biologics production
  • characterization of cell therapies to provide links to standardized clinical and laboratory outcomes
  • methods to validate pathogen inactivation for blood, plasma, tissues, and other products
  • multipathogen rapid detection methodologies
  • improvements to the longevity and storage of blood and tissues
  • new flu vaccine assays, standards, and reagents.

MODERNIZING SPECIFICATIONS Efforts to ensure the quality of biotech products also derive from FDA's GMP modernization campaign. While biotech manufacturers have incorporated many elements of a more risk-based oversight system into operations, the search continues for new ways to ensure product quality.

One current initiative seeks to help manufacturers adapt marketed products to meet changing needs and technological advances by setting more appropriate product specifications and limits. The current system has been criticized for relying on end-product testing to ensure that production batches are similar to batches tested in the clinic. This approach, though, fails to explain the relationship between specifications and desired clinical outcomes. Product specifications often are too wide, too tight, overly rigid, or irrelevant to clinical performance and thus frequently lead to excessive out-of-specification results that can be very costly.


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