Experience

Compass Biotechnology is a new consulting firm, but our partners have deep experience. The partners at Compass Biotechnology have over 70 years of experience in the biotechnology industry. We have experience in:

  • Large pharma and startup companies
  • Contract negotiation
  • Process development and transfer
  • Clinical and manufacturing scale production

Compass partners have worked to overcome challenges in regards to CMO negotiations/ongoing relations, fermentation and recovery process yield, purity and scale-up. We are skilled in writing, reviewing and editing the CMC sections of the US and international regulatory submissions (IND, BLA, CTD, IMPD, etc). Compass also has experience in Health Authority inspections, including new (PAI) and recurring agency inspections.

Projects that Compass partners have worked on:

Nexbio

NexBio

For its lead candidate, Fludase™, for the treatment of influenza, NexBio utilizes a semi-virtual business model, with their R&D managed internally, and their GMP manufacturing and testing being outsourced. A Compass partner managed their Drug Substance Development, Drug Product Development, Analytical Development, Manufacturing, Facilities and Quality programs.

Cell Genesys

Cell Genesys

A Compass partner managed Cell Genesys’s 100,000 sq ft biotech facility with direct and indirect oversight of its120 employees representing all facets of GMP operations, producing GVAX® cancer immunotherapies, with direct line function responsibility for Manufacturing, Facilities, Engineering and Supply Chain.

BioMarin

A Compass partner managed their CMC operations, facilitating and managing their FDA approval for N-acetylgalactoseamine-4-sulfatase (Naglazyme®). Also, managed the commercial manufacturing of both Naglazyme® and alpha-L-iduronidase (Aldurazyme®).

Onyx Pharmaceuticals

Onyx Pharmaceuticals

A Compass partner managed clinical development of the oncolytic adenovirus ONYX-015 program, which was subsequently commercialized by Sunway in China.

Bayer

Bayer

A Compass partner managed process development and protein characterization, working directly on rFVIII (Kogenate®), IgIV (Gamunex®), alpha-1PI (Prolastin®), and ATIII(Thrombate III®). Built and managed a new manufacturing science organization for Kogenate® operations, with separate groups providing technical support to the cell culture, purification and fill/finish production functional areas.

Genentech

Genentech

A Compass partner focused on fine tuning specific process development and protein characterization work. Worked on tPA (Activase®), IGF1 (Increlex®), anti-IgE (Xolair®), anti-Her2 (Herceptin®), and DNase (Pulmozyme®).

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