Aseptic Filling & Lyophilization

SynCo has a proven track record in the formulation and aseptic filling of monoclonal antibodies for a wide variety of companies and projects. SynCo is experienced in both clinical and market supply, with batch sizes up to 10,000 vials with fill volumes up to 22mL per DIN20R vial. The standard range of vial sizes is between DIN2R and DIN20R. 

Analytical and Regulatory Support

Analytical quality control comprises the testing of raw materials, packaging materials, bulk solutions, in-process materials and finished product (drug product). SynCo’s personnel are trained in state-of-the-art analytical techniques.

The instruments SynCo employs are validated according to current guidelines, and SynCo’s selected methods of analysis meet all international requirements for each project stage. SynCo also supports its clients in IMPD and IND filling during the clinical stages of the project.

In parallel with clinical-phase support, SynCo assists its customers in reviewing and preparing the appropriate CMC documents required for international product registration. SynCo’s personnel has extensive knowledge of all the FDA and EMA requirements and will ensure an efficient and cost-effective approval process. 

SynCo is also licensed to perform analytical testing of products (e.g. monoclonal antibody drug products) that are produced elsewhere. 

If you are interested in learning more about SynCo’s monoclonal antibody aseptic filling services, please do not hesitate to contact us.