Aseptic Filling & Lyophilization

SynCo has over 11 years of experience with aseptic filling and lyophilization of small volume parenterals (drug products) in its facilities. The processes used at SynCo for the manufacture of our client drug product batches are in compliance with EMA standards and FDA guidelines. SynCo has experience with both clinical and licensed product aseptic fill and lyophilization services for a broad range of biopharmaceuticals:

Aseptic liquid filling

• Monoclonal antibodies
• Recombinant proteins
• Alum-containing vaccines
• RNA/DNA
• Allergy vaccines
• Live biotherapeutic products (LBP)
• Diluents and placebo

Lyophilization (Lyoguard trays or vials)

• Recombinant proteins
• RNA/DNA
• Allergy vaccines
• Live biotherapeutic products (LBP)
• Placebo

Our aseptic filling operations are completed within our filling facility consisting of a formulation/preparation area as well as the principle filling area which contains a Flexicon FMB210L Monobloc semi-automated filling machine (filling, stoppering and capping) and Edwards freeze drier (6m²). Depending on vial size (DIN 2R to 20R), batch sizes up to 20,000 units per batch can be filled. 

Following the completion of the filling operations, SynCo’s well established Quality Control group with experience in the release testing of biopharmaceuticals for clinical trials and for licensed products will perform analytical testing of the filled product.

Through one of its partners SynCo is also able to offer formulation and freeze drying cycle development for direct implementation at its site in Amsterdam.

With its excellent project management systems, SynCo has the resources and flexibility to complete projects in a timely and cost-effective fashion.

If you are interested in learning more about SynCo's aseptic filling or lyophilization services please do not hesitate to contact us or to download our factsheet.