Aseptic Filling & Lyophilization

Some vaccines and other medicines contain ‘adjuvants’, which help stimulate the production of immunity against the vaccine ingredients, thereby increasing their efficacy. The word ‘adjuvant’ is derived from the Latin word ‘adjuvare’ which means ‘to help’. Aluminum salts have frequently been incorporated as adjuvants in vaccines licensed around the World. The aluminum is used to bring the antigen — the substance that stimulates the specific protective immune response — into contact with the immune system and to influence the type of immunity produced, as well as the quality of the immune response (magnitude or duration). The aluminum also decreases the toxicity of certain antigens and provides solubility to some vaccine components.

SynCo has acquired extensive expertise in both the formulation and aseptic filling of alum-containing vaccines (aluminum containing vaccines) in its facilities. The process concerning the formulation and the aseptic filling of the aluminum containing vaccines has been fully validated to ensure product homogenicity throughout the manufacture.

SynCo is experienced in both clinical and market supply 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. for the recombinant protein used in the aluminum-containing vaccine) that are produced elsewhere.

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