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Accelerated CMC workflows to enable speed to clinic in the COVID-19 era: A multi-company view from the biopharmaceutical industry.
Higgins, Matthew F; Abu-Absi, Nicholas; Gontarz, Elena; Gorr, Ingo H; Kaiser, Klaus; Patel, Pramthesh; Ritacco, Frank; Sheehy, Patrick; Thangaraj, Balakumar; Gill, Tony.
  • Higgins MF; BioPhorum Development Group, London, United Kingdom.
  • Abu-Absi N; AbbVie Bioresearch Center, Worcester, MA, USA.
  • Gontarz E; Thermo Fisher Pharma Services, St Louis, USA.
  • Gorr IH; Therapeutic Virus Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany.
  • Kaiser K; Bayer AG, Germany.
  • Patel P; GlaxoSmithKline, Philadelphia, USA.
  • Ritacco F; Thermo Fisher Pharma Services, St Louis, USA.
  • Sheehy P; Janssen Pharmaceuticals, Inc., Malvern, USA.
  • Thangaraj B; Catalent Pharma Solutions, Madison, USA.
  • Gill T; BioPhorum Development Group, London, United Kingdom.
Biotechnol Prog ; 39(2): e3321, 2023 03.
Article in English | MEDLINE | ID: covidwho-2296459
ABSTRACT
The COVID-19 pandemic has placed unprecedented pressure on biopharmaceutical companies to develop efficacious preventative and therapeutic treatments, which is unlikely to abate in the coming years. The importance of fast progress to clinical evaluation for treatments, which tackle unmet medical needs puts strain on traditional product development timelines, which can take years from start to finish. Although previous work has been successful in reducing phase 1 timelines for recombinant antibodies, through utilization of the latest technological advances and acceptance of greater business risk or costs, substantially faster development is likely achievable without increased risk to patients during initial clinical evaluation. To optimize lessons learned from the pandemic and maximize multi-stakeholder (i.e., patients, clinicians, companies, regulatory agencies) benefit, we conducted an industry wide benchmarking survey in September/October 2021. The aims of this survey were to (i) benchmark current technical practices of key process and product development activities related to manufacturing of therapeutic proteins, (ii) understand the impact of changes implemented in COVID-19 accelerated Ab programs, and whether any such changes can be retained as part of sustainable long-term business practices and (iii) understand whether any accelerative action(s) taken have (negatively) impacted the wider development process. This article provides an in-depth analysis of this data, ultimately highlighting an industry perspective of how biopharmaceutical companies can sustainably adopt new approaches to therapeutic protein development and production.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Biological Products / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Qualitative research Limits: Humans Language: English Journal: Biotechnol Prog Journal subject: Biotechnology Year: 2023 Document Type: Article Affiliation country: Btpr.3321

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Biological Products / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Qualitative research Limits: Humans Language: English Journal: Biotechnol Prog Journal subject: Biotechnology Year: 2023 Document Type: Article Affiliation country: Btpr.3321