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USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics

ISPE

USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics Trudy Patterson Fri, 07/07/2023 - 08:45 Features July / August 2023 USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics John F. This article summarizes trends from the workshop and ponders next steps. Biotechnology and Bioengineering (2023): 1–6.

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Exclusive Pharma Microbiology interview with Maria Jose Lopez Barragan, formerly at FDA

pharmaphorum

SMi Reports: An exclusive interview with María José López Barragán, Founder, Barragan BioConsulting, formerly CMC Product Quality Reviewer, FDA, who will be speaking at the 3rd Annual Pharmaceutical Microbiology East Coast Conference released. Workshop: October 30th, 2020. María José (Pepa) Lopez Barragán is a former U.S.

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Psychedelic medicines: are they gaining traction in Europe?

European Pharmaceutical Review

Legislative hurdles aside, in the same way as any other pharmaceutical companies, psychedelics companies will need to obtain regulatory approvals in the countries where they will carry out clinical trials or market products. Additionally, several US and Canadian states have legalised or decriminalised magic mushrooms.

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2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients

ISPE

The first keynote speaker was Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US FDA. He presented on “Quality: A Key Ingredient for Stable Pharmaceutical Supply Chains.”. Director, Office of Pharmaceutical Quality. Tue, 11/01/2022 - 06:49.

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Research Triangle: Building a Foundation for Pharmaceutical and Biotechnology Excellence

ISPE

Surrounded by universities and community colleges with life sciences programs, companies in RTP were able to access highly skilled graduates, increasing employment in the state. By the 1990s, pharmaceutical companies were looking to partner with contract research organizations (CROs) for drug development and clinical trials.

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Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing

ISPE

For example, one pharmaceutical company that switched to CM reported a 50% reduction in operating costs, a 33% reduction in waste, an 80% reduction in manufacturing and testing cycle time, and a 66% reduction in time from testing to release. 5 In addition, there are human elements to consider.

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