Weston, MA. Biotech and biotherapy are reaching new levels of sophistication and productivity. That inevitably makes health product regulation more demanding and complex. Nothing arouses more interest and concern than transgenicism, or the successful insertion of a gene from one organism into another through recombinant DNA methodology. Whether genetically engineered crops, medicines, or transgenic animals are involved, people are asking what’s in the combination and which ethical and regulatory policies need updating to keep pace with the advance of science.

On Wednesday, February 24, the Boston Chapter of the Regulatory Affairs Professionals Society (RAPS) will meet at Regis College to debate some of these questions. Mina Gerber and Debra Trainor from GTC Biotherapeutics Inc will present on "Strategic and Regulatory Considerations for Transgenic Product Development," reviewing the transgenic production process and outlining the challenges of regulatory compliance in manufacturing with the transgenic platform.

The basis for the case study to be explored is GTC Biotherapeutics Inc.’s ATryn®, the first transgenically produced protein to be approved for human therapeutic use and first recombinant antithrombin product approved anywhere in the world. ATryn is also the first antithrombin product approved through the European Medicines Agency’s Centralised Procedure. Being the first approved transgenic product, GTC developed numerous novel quality systems for the management of the transgenic herd, the collection of source material, and the interpretation and application of the existing biologics and transgenic guidelines to its manufacturing platform in order to attain compliance and regulatory approval.

Speakers Mina Gerber, RAC, and Debra Winslow-Trainor are, respectively, the senior director, quality assurance, GTC Biotherapeutics, Inc., and the vice president, project management and operations planning, GTC Biotherapeutics, Inc.

Sponsored by the RAPS Boston Chapter, the gathering is intended for professionals to promote knowledge and facilitate networking among local regulatory professionals. Attendees are eligible for 1.5 RAC recertification points. Regis College faculty member Charles Burr, SM, MBA, was inducted as a RAPS Fellow in the fall, 2009, and leads the Health Product Regulation Program at the College helping the personnel of local industries keep up with the variety and multitude of regulations and policies.