Drugs

Pros and Cons of Continuous Manufacturing Guidance

GlaxoSmithKline says a draft FDA guidance on quality considerations for continuous manufacturing is “a good first step toward establishing current Good Manufacturing Practices around emerging continuous manufacturing technology.” The company says it expects that once the International Conference on Harmonization Q13 guideline on continuous manufacturing of drug substances and drug products is adopted and implemented, FDA will withdraw its guidance and align to the Q13 practices and recommendations to ensure global harmonization of the new technology.

A similar view on Q13 was expressed by the Active Pharmaceutical Ingredient Committee.

Apotex cautions that although the draft is conceptually innovative, it proposes significant changes in knowledge, risk, change, and talent management, which will have a huge impact on the current traditional manufacturing setup and operations. “Apotex is of the opinion that the proposed guidance may increase the burden of product development, manufacture, and overall cost for the industry,” it says.

That caution also was raised by the Association for Accessible Medicines (AAM), which says it applauds the progress in continuous manufacturing and encourages its member companies to fully explore its potential benefit. “At the same time,” it says, “AAM is keenly aware of the many economic and practical considerations that clearly demonstrate that continuous manufacturing is not the panacea it is often depicted to be.” The generic and biosimilar drug trade group says policy makers and thought leaders should consider both the benefits and costs involved in adopting continuous manufacturing.

Bayer presented specific technical comments, as did several others.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome