SynCo regularly is approached by members of the biopharmaceutical market to fill a number of novel product-types.  Its medium-size automated fill facility for the GMP production of biopharmaceuticals is second-to-none and its experience in biologics is one of the widest in the industry.  Projects completed have included:
• Monoclonal antibodies
• Recombinant proteins
• Allergy vaccines
• Alum-containing vaccines
• Multi-protein containing products with complex formulation processes
• Live-microbial-based products
• Polysaccharides

Each of these product types is very different and the formulation and fill setup varies.  For one such project in 2008, SynCo was requested to fill a product for which few fill facilities have experience.  This was for the filling of a protein-based medicine into 20 R vials.

With any biopharmaceutical product, SynCo is well aware that bulk drug substance material is extremely valuable.  Therefore, when a new product-type is to enter its filling facilities, SynCo takes a risk-based approach and recommends the best course of action to its clients to minimize expensive losses during GMP filling. 

Stage 1

As the client’s (Company X) product-type was new to the SynCo facility and process losses had to be kept to a minimum, SynCo recommended a feasibility study to allow potential product losses to be evaluated and to ensure that the right number of vials at the right volume were produced.  This involved the completion of:
• Dry run to check BPRs, and equipment settings
• Wet feasibility run with formulation buffer only.  This enabled fill line and needles to be tested with the aim of minimizing future product losses and reducing potential foaming in the vial.

Following the successful completion of this short piece of work (1 week only), GMP batches for use in Phase I US clinical trials were filled and released with minimal losses.  This enabled company X’ timelines to be met and clinical milestones to be reached.

Stage 2

Following the successful completion of stage 1 of company X’ project and the development of a strong relationship between SynCo and its client, company X requested that SynCo complete the next phase of clinical filling and triple its standard batch size to accommodate its later phase clinical plans.

SynCo was extremely committed to the success of its client and was keen to work with its client to expand its capabilities.  SynCo therefore completed a study to determine how it could increase its total fill size, followed by testing this planning with process validation (3 x media fill simulations).  This was undertaken successfully and enabled SynCo and company X to work together in the production of Phase II US clinical trial supplies.

This case exemplifies SynCo’s aims to develop strong collaborative relationships and to grow with its clients.

For more information, please send an email to contact@syncobiopartners.com