Developments and opportunities in continuous biopharmaceutical manufacturing

Challenges and opportunities in biopharmaceutical manufacturing control

The total sales of biopharmaceuticals have been steadily increasing for decades with growing approval of new drug products, especially for monoclonal antibodies. This trend motivates the development of deeper understanding and advancement of biopharmaceutical manufacturing operations. This article describes opportunities, needs, and challenges in process control and operations for biopharmaceut...

Advances in Biopharmaceutical and Vaccine Manufacturing Plants

Sei Murakami, Dr. Eng. Haruo Suzuki Keisuke Shibuya, Dr. Sc. OVERVIEW: The development of innovative pharmaceuticals with potential for meeting unmet medical needs and vaccines that protect against infectious diseases is very important for ensuring people’s health and welfare. However, biopharmaceuticals and vaccines that make these developments possible are more easily affected by the producti...

Opportunities , challenges and regulatory developments

Vertical Integration of Disposables in Biopharmaceutical Drug Substance Manufacturing

level: interMediAte S ingle-use (disposable) technologies are gaining significant traction in biopharmaceutical manufacturing due to reductions in capital investment for plant construction, lower requirements for cleaning and sterilization, and the advantages of eliminating crosscontamination during multiproduct manufacturing (1–4). In the early days of disposables, single-use (SU) systems were...

Implementation of Single-Use Technology in Biopharmaceutical Manufacturing