Bringing a biologic to market is not easy, and there are several key considerations to how sponsor companies should approach commercial-scale manufacturing that may aid the success of their product’s commercial launch. In this article, experts share how scale-up, regulatory expectations, demand forecasting and process validation play into the success of a biologic's commercial manufacturing journey.
The choice of potential technology transfer partners can be bewildering. Understand how factors such as consolidation, outsourcing, as well as equipment and material challenges should be taken into consideration when making this decision.
Two of the challenges in thr early stages of a pharmaceutical are a limited supply of protein to use in formulation screening studies, and a need to obtain stability data quickly to initiate tox studies. In this poster, scientists at Catalent Biologics outline a method of utilizing a high-throughput, microwell plate platform to economically screen a monoclonal antibody (mAb) in 96 formulations.
Catalent Biologics is your one integrated partner with expertise to get your biologic to market faster. We have the passion to help you accelerate, simplify, and derisk your next biologic from development and manufacturing, to fill/finish, clinical supply, and commercial launch.