Barriers to Innovations in Pharmaceutical Manufacturing Proceedings of a Workshop–in Brief (2020) / Chapter Skim
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Barriers to Innovations in Pharmaceutical Manufacturing: Proceedings of a Workshop - in Brief
Barriers to Innovations in Pharmaceutical Manufacturing: Proceedings of a Workshop - in Brief
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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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DELIVERING ON MANUFACTURING INNOVATION: CHALLENGES AND OPPORTUNITIES Roger Nosal, vice president and head of global chemistry, manufacturing and controls (CMC) at Pfizer, opened the first session by highlighting substantial regulatory challenges in advancing innovations in pharmaceutical manufacturing.
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She began by listing several drivers of flexible manufacturing: the movement toward specialized products that are manufactured in smaller volumes, the desire to reduce operating costs, the need to respond rapidly to changes in demand, the need to avoid drug shortages, and the pressure to accelerate drug development. She said that innovations -- such as continuous manufacturing, portable manufacturing, real-time analytics, single-use systems, and point-of-care manufacturing -- are being pursued to create the flexible manufacturing desired.
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Lee emphasized the importance of incentives to accelerate innovative approaches; in the absence of incentives, it will take years to implement what should be relatively straightforward technologies. 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.
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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. He described a continuous manufacturing facility in which unit operations are contained in PODs that can be moved in and out and reconfigured.
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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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Starkey concluded that introducing innovative technology remains a challenge in the global setting; when a company that develops regulatory submissions intended for a global supply chain faces regulatory feedback or standards that are out of broader international alignment, that discordance encourages a company to follow the path of least resistance for global registrations. Discussion Stephen Hadley, senior program officer for vaccine development at the Bill & Melinda Gates Foundation, moderated a panel discussion with the speakers and the workshop audience and began by asking the speakers to reflect on the challenges raised during the session.
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Brent Lieffers, senior director of operations at Singota Solutions, discussed modern aseptic processing and challenges associated with validation. He stated that the trajectory of drug development for biologics involves delivery methods that are parenteral and bypass the gastrointestinal tract, so aseptic processing is required.
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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. To provide insight into the barriers that a company can face, Jae Yoo, chief technology officer at Aprecia Pharmaceuticals LLC, described his company's journey from technology development to FDA approval of 3D printing of pharmaceutical dosage forms.
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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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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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2020. Barriers to Innovations in Pharmaceutical Manufacturing: Proceedings of a Workshop -- in Brief.
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