Biologics

Drug Product Development

Developability and Formulation Screening Platform

Asymchem’s leading formulation development platform builds developability studies that support higher success rates. We employ Design-of-Experiment-based formulation screening to identify traditional and innovative formulation candidates for regular mAb or protein molecules (such as fusion proteins/enzymes) with unique stability challenges. Formulation confirmation and long-term stability studies are also part of our platform.

Our highly integrated drug product development platform also supports studies such as forced degradation, container/closure screening (CCS), integrity testing, and clinical in-use study.

Development Platform

Quality by design is integral to process development (PD) for the liquid filling steps. Scale-down models are used in every step (freeze/thaw, pool/mixing, aseptic filter, filling) to sufficiently understand the production processes (CPPs and AORs). These studies and models guide subsequent GMP scale up and tech transfer to ensure success.

Advanced lyophilization PD, including determination of excipients, Tg and Tc determination, lyo product physicochemical property determination, container/stopper selection, and lyo cycle development are done. These studies support the formulation development of an unstable molecule in liquid.

Non-GMP / GMP Pilot Aseptic Liquid Filling / Lyophilization Production Platform

Asymchem uses a septic liquid filling/lyophilization production line with advanced washing, depyrogenation, filling, and capping assembly functions. It supports pilot-scale production of small volume parenteral (SVP) (including lyophilized products) in a broad range of vial formats. A pre-filled syringe fill/finish production line is under construction.

Aseptic liquid Filling / lyophilization production platform supports the development and validation of processes during freeze and thaw, buffer preparation, sterile filtration, filling, lyophilization, stoppering and capping for biologics. In addition, our advanced environmental monitoring system ensures the pilot production for various types of biologics under cGMP conditions.