Final Container Extractables & Leachables Study

We offer an excellent platform for extractables and leachables study of vial, stopper and PFS. Our services include: Container closure selection and integrity test; Container closure extractables and leachables study using GC-FID, GC-MS/MS, ICP-MS, LC-MS/MS;...

Drug Developability / Manufacturability study

We offer a perfect platform for drug developability evaluation during multiple stages of drug development. Our services include: Potential hot spots for degradation and oxidation analysis; Conformational, colloidal and thermal stability study using high-throughput...

Aseptic Filling and Freeze-drying

Our team provides the entire drug product manufacturing chain comprising liquid fill & finish and lyophilization. We offer final drug product formulation, fill & finish and lyophilization services compliant with cGMP conditions. Aseptic filling of sterile...

Formulation Development

Our Pharmaceutical Development team is highly skilled in the development of biopharmaceuticals including standard monoclonal antibodies, recombinant proteins, fusion proteins, antibody-drug-conjugates (ADCs) and peptides. Our experienced Pharmaceutical Development...

Process Development

Cell culture process technology platform provides for optimization of media, seeding densities, feeding and bioreactor process control strategies to maximize expression, enhance process reproducibility and facilitate scale-up. Adaption of cell line to suspension...