Innovations in Pharmaceutical Manufacturing on the Horizon Technical Challenges, Regulatory Issues, and Recommendations (2021) / Chapter Skim
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Appendix E: Barriers to Innovations in Pharmaceutical Manufacturing Proceeding of a Workshop - in Brief
Appendix E: Barriers to Innovations in Pharmaceutical Manufacturing Proceeding of a Workshop - in Brief
Pages 97-110
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From page 97... ...
Kopcha stated that 62% of drug shortages result from quality issues and that advanced manufacturing could help to address supply disruptions. Advanced manufacturing includes novel manufacturing methods that can improve process robustness and efficiency, novel dosage forms that can improve drug delivery and targeting, and analytical tools that can improve product quality testing, process monitoring, and control.
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From page 98... ...
at Pfizer, opened the first session by highlighting substantial regulatory challenges in advancing innovations in pharmaceutical manufacturing. He noted that the pharmaceutical industry has often been characterized as using outdated technology, relying on vulnerable and complex supply chains, having too limited and fixed capacity, and being overregulated.
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From page 99... ...
Benefits of continuous manufacturing include shorter processing times, integrated unit operations, a smaller equipment footprint, elimination of traditional scale-up, and a system that enables real-time analytics and control. Technical and regulatory challenges include uncertainties regarding real-time release testing and controls and possible difficulties in tracing materials through the system, predicting disturbances of homogeneity, and segregating potentially nonconforming material.
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From page 100... ...
To achieve flexible, agile manufacturing, however, he noted that an industry survey conducted by NIIMBL indicated that analytical technologies and technologies associated with upstream operation and process monitoring and control are needed.5 Lee next described an active listening meeting between the industry and FDA to understand the challenges in implementing new technologies in biopharmaceutical manufacturing.5 Companies were asked to consider several questions and were then interviewed individually before the meeting to identify consensus topics and areas of concern. The process revealed that the industry has had a wide variety of experiences with CDER and that the industry can rarely identify a business case for implementing new manufacturing technologies.
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From page 101... ...
BLURRING THE BOUNDARIES: INTEGRATION, INTENSIFICATION, AND CONTROL Paul Collins, senior director of small molecule design and development at Eli Lilly and Company, opened the afternoon session by suggesting that continuous manufacturing is key to the future of new drug development. He said that the human genome project opened the door to new modalities and that pharmaceutical processing operations need to evolve to produce new drugs.
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From page 102... ...
Thomas agreed with Collins that it is critical to shrink the footprint of unit operations so that a company can optimize its facilities and that one approach is to use continuous manufacturing. He said that using continuous manufacturing successfully for biologics requires a focus on a few critical needs: aseptic conditions throughout the entire production process, process control that can maximize productivity while delivering consistent product quality, and a supply chain for high-quality disposables and consumables used in the process.
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From page 103... ...
Kim Wolfram, director of regulatory CMC at Biogen, discussed the alchemy of process control, which she defined as the transformation of designated process controls into a control strategy that is derived from prior knowledge and product and process design and that ensures process performance, product quality, and sustainable supply. She added that regulatory flexibility is needed and that the strategy needs to be built on a foundation of trust, diversity and inclusion, and patient-centricity.
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From page 104... ...
He emphasized that advanced process control strategies allow one to ensure product quality by understanding and monitoring process and analytical controls, not simply by product testing. The key, he said, is to understand how process controls affect product characteristics, such as glycosylation on antibodies, which ultimately might affect potency.
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From page 105... ...
She said that product development and manufacturing challenges include sophisticated technologies required to produce complex dosage forms and the need for new devices to deliver products, aseptic manufacturing conditions, long shelf-life, and cost-effective approaches. Zhao elaborated on the regulatory challenges.
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From page 106... ...
printing, can also pose some issues inasmuch as defects in a new product might not be similar to the defects in traditional products and that there might even be questions about how to categorize the product created. Khan concluded that the keys to developing and implementing innovative technologies are to continue to develop strong science-based policies, to use internal and external resources to promote and publicize innovative products and manufacturing, to understand past recalls and connect solutions with modernization of pharmaceutical manufacturing, and to recognize and promote advances in science in the regulatory agencies.
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From page 107... ...
Discussion Kelley Rogers, NIIMBL technical program manager in the Office of Advanced Manufacturing at the National Institute of Standards and Technology, moderated the panel discussion with speakers and workshop audience. Several questions were raised about the 3D printing process for pharmaceuticals.
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From page 108... ...
Hershenson hoped that regulatory approaches would evolve soon that facilitate approval of dosage forms that use an active pharmaceutical ingredient that has already proved to be safe and effective. In 10 years, she hopes, mobile manufacturing units described earlier in the workshop will become a reality because they would greatly strengthen global supply chains.
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From page 109... ...
He added that intensified continuous manufacturing is being investigated as the next-generation platform to improve productivity and efficiency and reduce the equipment footprint. Afeyan concluded his presentation by describing three innovations in cellular therapy.
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From page 110... ...
2020. Barriers to Innovations in Pharmaceutical Manufacturing: Proceedings of a Workshop -- in Brief.
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