Small molecules continue to dominate over biologics in new pharmaceutical product launches, comprising 33 of the 50 approvals by the US Food and Drug Administration’s Center for Drug Evaluation and Research in 2021, writes Stephen Byard, Principal Research Fellow, Science & Technology, Candidate Development at Quotient Sciences.
The trend toward outsourcing pharmaceutical development and manufacturing has accelerated during the Covid pandemic as pharma companies – globally – seek to streamline their own facilities, focus on core competencies and avoid product delays inherent in decentralized international manufacturing.
Each molecule has unique requirements and challenges, and a variety of solutions for drug substance synthesis and manufacturing are available, so it is important to have a keen understanding of the strategies that can help streamline these processes
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