Name: Macrogenics, Inc.
Address: 9704 Medical Center Dr, Rockville, MD, 20850-3368, US
Telephone: (301) 251-5172

The employees at MacroGenics are committed to our mission of delivering life-changing medicines to patients. We leverage our world-class capabilities in biologic discovery, development and production to create novel product candidates that are highly differentiated and which are intended to address areas of significant unmet clinical need.

We embrace this mission recognizing its boldness and appreciating the challenges that incumbents in the industry have faced. The discovery and development of novel therapeutics is a process that has historically been characterized by long development timelines, significant investment, high rates of program failure and increasingly stringent requirements by both payors and regulators.

We believe our approach to product development is a unique source of competitive advantage. Our product development model has been constructed with three fundamental goals: identifying the right product candidates early, moving these product candidates quickly through the development process, and always maintaining a keen awareness of the need for improved health outcomes for patients.

Identifying the Right Product Candidates Early and Efficiently Transitioning into Clinical Development

MacroGenics has instituted a rigorous process for characterizing and selecting our development candidates. Given the size of our antibody library, which includes over 1, 300 purified antibodies directed at over 60 different antigens, we are able to prioritize only the most promising programs for additional development. In some instances, we have evaluated as many as 40 different antibodies against a single target antigen before selecting our lead development candidate. We analyze the underlying viability of the target, the biochemical and biophysical attributes of the antibody, and the functional activity of the antibody. Once we have decided on the most promising target and most robust antibody product candidate, we further leverage our world-class protein engineering technologies to select the platform which confers the greatest therapeutic advantages. For instance, we may elect either an Fc optimized antibody or a DART antibody. The result of our approach is a very robust portfolio of clinical candidates, and a highly efficient clinical development program with a reduced risk of downstream failure.

In just fifteen months, MacroGenics was able to in-license an antibody from an academic investigator's lab, re-engineer the product, produce GMP drug supply and initiate a pivotal clinical trial for type 1 diabetes. This treatment represents a significant paradigm shift for a very important medical condition, for which there has not been a new medicine approved since the 1920's. Within the fifteen month period, MacroGenics completed the following:

Generated a CHO cell line versus the original NS0 cell line;

Developed and released the master cell bank;

Manufactured three full-scale lots in a new MacroGenics' cGMP manufacturing suite;

Established and performed 14 assays to establish comparability between the NS0 and CHO material;

Successfully engaged with the U.S. and European regulatory authorities to initiate a Phase 2/3 clinical trial globally; and

Received Orphan Drug designation from the FDA.

Within one year of launching its first pivotal trial, MacroGenics entered into a significant global alliance with Eli Lilly and Company for the development of teplizumab. Learn more

Macrogenics, Inc.

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