Friday, July 16, 2010

Development of Antibody-Based Therapeutics

The antibody-based therapeutic market continues to demonstrate an impressive growth and expansion within the pharmaceutical arena. Since 2000, the monoclonal antibody market has grown in the number of approved clinical submissions to FDA as well as expansion in therapeutic indication and focus. Currently the top therapeutic indications and market focus are oncology, autoimmune, infectious disease and AIID. Brand products or products in discovery and in clinical development or on the regulatory pathway to clinical submission are generated by large pharma in the past. Since 2000, more companies, large and small will be in the market and discovery modes involving therapeutic monoclonal antibody-based products.

The market forecast for antibody-based products will continue to rise between 2010-2011. AIID emerging discovery is gaining dominance over R&D oncology targets and treatments. The science is unique and discriminates itself from other therapeutic modalities such as devices, small and large molecules, synthetics, otherwise. Successful strategies for clinical development require integration of relevant knowledge pertaining to target antigen properties, antibody design, affinity, isotope selection, isolation, characterization, PK/PD properties, biophysical, biochemical characterization, cross-reactivity, sensitivity and specificity analyses. The first product in this class of therapeutics was approved by FDA in 1986, Muromonab-CD3, a T cell CD3 Receptor, for Transplant Rejection. Since the first approval by FDA, there are numerous approved products successfully marketed and demonstrating predicted "intended use" directives. The clinical development plan is generic, however specific to each product on its way from discovery to the clinic. R&D, characterization, preclinical, clinical, regulatory, submission, via PMA, 510(k) is the general path. Quality management plans and systems are essential and often reviewed first by FDA before substantive content is considered. Use quality control measures to ensure data and documentation accuracy and consistency, adhere to process, procedures and ensure regulatory compliance for success.

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