GTC Biotherapeutics, Inc. (GTC, Framingham, MA) has entered into an extended agreement with PharmAthene, Inc. (Annapolis, MD) under which GTC will provide continuing process development and clinical supply manufacturing services for PharmAthene’s Protexia program.
GTC Biotherapeutics, Inc. (GTC, Framingham, MA) has entered into an extended agreement with PharmAthene, Inc. (Annapolis, MD) under which GTC will provide continuing process development and clinical supply manufacturing services for PharmAthene’s Protexia program. The manufacturing work is planned to conclude in the third quarter of 2008. Protexia is a recombinant form of human butyrylcholinesterase (rBChE) produced in the milk of transgenic goats, which is being developed by PharmAthene as a pre- and post-exposure therapy for victims of a chemical nerve agent attack.
Although the use of human plasma derived butyrylcholinesterase (BChE) to protect against nerve agent toxicity is well documented, a major limitation hindering its commercial development has been the inability to produce commercial quantities because of a limited availability of appropriate blood supplies, low levels of the protein in plasma, and low production yields using traditional biotechnology methods. Protexia overcomes these limitations by enabling substantially larger production yields than are possible using other expression systems or through purification of the native protein from human plasma. Transgenic production and manufacturing is estimated to be capable of supplying sufficient rBChE to make Protexia available for use by the military and civilian populations.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Oligonucleotide Analysis in Pharmaceutical Quality Control
January 14th 2025Melting point determination using ultraviolet-visible (UV-Vis) spectrophotometry can be used as a sequence-specific method for identifying therapeutic oligonucleotides in pharmaceutical quality control. This method offers a simple, highly selective approach to differentiate between isomers and ensure the integrity of oligonucleotide active pharmaceutical ingredients (APIs) and drug products.