Our team has over 100 years of experience in the development of marketed biologics. Our experiences in biotechnology began as early as 1980 and several of us were key to early drug development at Genentech, demonstrated by over 30 years of cumulative time at this pioneering company. Team members have played major roles in the development of seven marketed products with a cumulative market value in excess of $20 billion. The protein products and drug candidates the team has worked with encompass a variety of classes of proteins such as: growth factors, cytokines, proteins in the clotting cascade, neurotrophic factors, fusion proteins and monoclonal antibodies.

Market Research

We can provide you with an understanding of the evolving, competitive landscape of biosimilars. We are familiar with the opportunities, challenges and competition to be faced in the marketplace. Our ability to stay up to date with new developments, progress and advancements in biosimilars is backed by our scientific and business backgrounds and our knowledge of the molecules in play and their intellectual property status. We can help you find out what you need to know to support you with commercialization strategy, due diligence, and intellectual property analysis.

DNA Sequence With Full Documentation

To build our proprietary protein therapeutics database, we have gathered original source information on all approved protein therapeutics. A key feature in the development of this database is the protein sequence for the originator drug. In many cases, the branded drugs have been sequenced to validate the sequences identified. In addition to the protein sequence of the branded drug, in most cases, we can provide information on patent expiry dates for IP covering the DNA and protein sequences.

Cell Line Development

We can provide access to comprehensive and rapid solutions for stable, high yield mammalian cell lines used in recombinant protein manufacturing of therapeutic drugs. Our selected Cell Line Development contract services and technology can significantly reduce traditional mammalian cell line development (e.g. DHFR) from approximately 12 months to as little as 6 weeks. These selected technologies have been proven to improve the yield and stability of production cell lines and has been found to increase recombinant protein expression up to 20 foldfor mammalian cells in serum free suspension culture.

Members of our team have been involved in the development of production cell lines for such branded products as Activase, Kogenate, Herceptin, Xolair and Avastin. In addition, team members have also been associated with the development of production cell lines for Adalimumab, Cetuximab, Darbepoetin, Etanercept, Infliximab, and Rituximab. Taken together, team members have impacted the development of over 400 protein production cell lines.

Process Development / Manufacturing

Our team’s experience includes the process development and transfer of scalable isolation/purification processes for pre-clinical, clinical and commercial manufacturing of recombinant products, from the bench top scale to 10,000L. Our advanced know-how and expertise in purification, separation and recovery technologies ireflects our ability to achieve and maintain technical know-how in recombinant pharmaceuticals production. In the manufacturing of recombinant proteins, our team members have developed, transferred and implemented production processes for both INDs and BLAs. We are familiar with the requirements for GMP production of clinical grade and commercial materials. We have been involved in facility design, development, auditing and operations. We can provide strategy, guidance and troubleshooting in the development of biosimilar manufacturing processes. In advance of manufacturing, we can work with you to provide assistance in the selection and management of quality, cost effective contract services for both the development and manufacturing of your biosimilar. We can be by your side during the process development of production processes and the technical transfer and implementation of those processes to the contract manufacturing organization, helping to insure accurate and effective operations to produce your product. Where necessary, we can perform process and operations troubleshooting and evaluate or audit facilities or technologies for your program.

CMC Project Support and Documentation

We can assist you to develop and implement a complete CMC strategy, with a forward looking view. The experience of our team enables us to anticipate CMC development issues and devise effective approaches to overcome obstacles. We are very familiar with the interplay between the CMC components of your package and the needs of other development disciplines such as Preclinical Safety, Clinical Evaluation and Regulatory.

We can provide experienced CMC project management, from assistance with technology transfers to the selection and management of contract service organizations (CMOs, CDOs, and selected CROs). We can support you through the development of the strategy for, the writing of and the reviewing of pertinent CMC regulatory documentation.