25 April 2024 | Thursday | News
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AGC Biologics announced the completion of work with VAR2 Pharmaceuticals on the production of the company’s two antibody candidates targeting cancer-specific carbohydrate structures for cancer treatment.
The CDMO’s work included information transfer and master cell bank creation, method implementation, pilot-scale evaluations, preparation for large-scale manufacturing, regulatory documentation support for EMA or FDA guidelines and product stability studies.
"We prioritize unparalleled support for every project we undertake, ensuring our clients receive the highest level of service and satisfaction. This project is a good example of how fast we are able to deliver results in close collaboration with our clients," said Dieter Kramer, General Manager of AGC Biologics Heidelberg.
VAR2 Pharmaceuticals proprietary antibody fragments –Vartumabs – have been shown to bind with high affinity and high specificity to onco-fetal Chondroitin Sulfate, a pan-cancer, tumor-specific glycosaminoglycan first identified by VAR2 Pharmaceuticals. The two antibody fragments produced in collaboration with AGC Biologics will be used in an upcoming, first-in-human, nuclear imaging microdosing study paving the way for efficacy trials.
AGC Biologics runs multiple cGMP microbial production lines at its Heidelberg facility. The AGC Biologics Heidelberg site has produced biologics products for 40 years and has built a track record for navigating clients through the early clinical phases and into later stages, including commercial production. In addition to protein-based biologics, the site serves as the CDMO’s Center of Excellence for plasmid DNA (pDNA) and messenger RNA (mRNA), offering full-scale support for microbial drug substances, plasmid materials, starting material for in-vitro transcription mRNA vaccines, and raw material for adeno-associated vectors and lentiviral vectors.
The AGC Biologics Heidelberg facility has been producing biopharmaceuticals for four decades. The facility offers developer partners a segregated line design that increases flexibility and cGMP compliance.
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