White Paper

Industry Best Practices For Novel Biotherapeutic Entities

Antibody

After years of study, bispecific antibodies and antibody drug conjugates (ADCs) are rapidly coming to the forefront of therapeutic research. The modular architecture of antibodies offers the potential to create highly specific therapeutics. More than 35 formats of bispecific antibodies and derived constructs are under development by biopharma companies and several are approved for therapy. As this next wave of antibody-based therapies gains momentum, biochemists have begun to create even more innovative molecules with additional modes of action including multispecific antibodies and other so-called Frankenmolecules.

However, informatics technologies have not kept pace with these scientific innovations. That makes it difficult for people in pharmaceutical  companies to work with novel constructs in a unified and efficient way. These professionals face tough questions. How do we store information about new biological entities so that it is searchable and sharable? How do we register them and what is the accepted standard for regulatory submission? How do we ensure we have complete information about these molecules so we can make educated decisions?

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