Aseptic Filling & Lyophilization

SynCo has developed a unique position in the area of live biotherapeutic product (LBP) manufacture. In addition to manufacture of the drug substance of LBPs, SynCo has acquired extensive experience in the niche market of filling LBPs in its aseptic filling facility.

With its unique approach in only using disposable technology for the production of these drug products, SynCo has produced a considerable number of different LBPs for both clinical and market supply. These include: Lactococcus lactis, Lactobacillus acidophilus, Oxalobacter formigenes, Bifidobacterium lactis and Bifidobacterium longum. 

The projects range from liquid fills and freezing (-20˚C or -70˚C) the drug product to performing the liquid fill including lyophilization, with batches sizes up to 20,000 vials. 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. LBPs) that are produced elsewhere.

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