FDA Seeks to Advance Pharma Manufacturing


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 05-29-2014 19:10

  

FDA has issued a Broad Agency Announcement (BAA) for soliciting research and development to support regulatory science and innovation, which includes innovation in manufacturing. The BAA fulfills an FDA requirement to use industry capabilities for advancing and achieving improvements in technology, materials, processes, methods, devices, or techniques for specific topics, and the agency has selected nine topics, which includes manufacturing. The nine areas of focus of the BAA are to:

  • Modernize toxicology to enhance product safety; 
  • Stimulate innovation in clinical evaluations and personalized medicine to improve product development and patient outcomes
  • Support new approaches to improve product manufacturing and quality;
  • Ensure FDA readiness to evaluate innovative emerging technologies;
  • Harness diverse data through information sciences to improve health outcomes;
  • Implement a new prevention-focused food safety system to protect public health;
  • Facilitate development of medical countermeasures to protect against threats to US and global health and security;
  • Strengthen social and behavioral science at FDA by enhancing audience understanding; and 
  • Strengthen the global product safety net.

With respect to manufacturing, FDA is seeking to support the application of novel technologies to product development and innovative analytical approaches to improve product manufacturing and quality through active research intramural and collaboratively with external partners. With respect to manufacturing, the agency wants to:

  •  Investigate the effects of continuous manufacturing (manufacturing using a continuous process, rather than a batch approach) on product quality; t>
  • Examine specific novel manufacturing technologies to determine how they impact product failure rates; and
  • Evaluate the role excipients and complex dosage forms on product safety, efficacy, and quality and further process analytical technology and quality-by-design approaches to maintain consistent quality. With respect to advancing innovative analytical methods, the agency wants to:  
  • Investigate the feasibility and value of using emerging and improved analytical technologies, such as nuclear magnetic resonance), mass spectrometry, or near infrared or Raman spectroscopy for evaluating product quality of pharmaceutical agents, and evaluate whether these technologies should replace existing methods;
  • Evaluate applicability of various analytic technologies for determination of the "similarity" of biosimilars to their reference products;
  • Perform statistical research to support development and evaluation of new assays and tests needed to assure analytical methods give consistent reproducible results; and
  • Develop improved methods and tools to detect and measure the physical structure, chemical properties, and safety of engineered nanomaterials and complex dosage forms (e.g., transdermal patches, inhalation delivery systems, and targeted drug delivery systems etc.) in FDA-regulated products.

The agency also wants to develop ways to reduce risk of microbial contamination of products with two areas of specific interest to:

  • Develop sensitive, rapid, high-throughput methods to detect, identify, and enumerate microbial contaminants and validate their utility in assessing product sterility; and
  • Develop and evaluate methods for microbial inactivation/removal from pharmaceutical products that are not amenable to conventional methods of sterilization.
Anticipated funding for the program (not per contract or award) may range from $200,000 to $6 million, subject to Congressional appropriations. This funding profile is an estimate only and will not be a contractual obligation for funding. All funding is subject to change due to government discretion and availability. To be eligible for award, a prospective recipient must meet certain minimum standards pertaining to financial resources, ability to comply with the performance schedule, prior record of performance, integrity, organization, experience, operational controls, technical controls, technical skills, facilities, and equipment.This BAA is open to all responsible sources. Offerors may include single entities or teams from private sector organizations, government laboratories, federally funded research and development centers, and academic institutions.

Source: FDA




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