The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
The authors review the various analytical methods that can enable use of PAT.
Challenges of vaccine development include regulatory, technical, and manufacturing hurdles in translating a vaccine candidate into a commercial product.
The author explains the current status of India, the challenges, and recommendations that may alleviate these challenges.
The authors focus on operational excellence in manufacturing of biotechnology therapeutic products in the QbD paradigm.
The authors encourage biotech manufacturers to consult PDA Technical Report No. 49 for a detailed perspective on current practices and issues in biotech cleaning validation.
An approach to reduce batch time, increase productivity, and decrease costs.