–News Direct–
AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced the completion of work with VAR2 Pharmaceuticals on the production of the companys two antibody candidates targeting cancer-specific carbohydrate structures for cancer treatment.
The CDMOs 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 with an ADC.
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 CDMOs 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.
To learn more about microbial system-based biologics, pDNA, and mRNA development and manufacturing at AGC Biologics Heidelberg, visit www.agcbio.com/facilities/heidelberg.
For more information on our Protein Biologics, pDNA, Cell Therapy, Viral Vector and mRNA drug product services go to www.agcbio.com.
About VAR2 Pharmaceuticals ApS
VAR2 Pharmaceuticals is a near-clinical stage biotechnology company developing first-in-class therapeutics for onco-fetal Chondroitin Sulfate, a pan-cancer, tumor-specific glycosaminoglycan discovered by VAR2 Pharmaceuticals during malaria research. Founded in 2012, VAR2 Pharmaceuticals is based in Copenhagen and has raised >20M to date. Our experienced team of innovators and scientists are committed to developing safe and effective cancer therapies targeting this unique cancer-specific carbohydrate modification, with a particular focus on hard-to-treat, recurrent and metastatic cancers. For additional information, please visit www.var2pharma.com.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is a part of AGC Inc.s Life Science Company. The Life Science company runs more than 10 global facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com.
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AGC Biologics
COMTEX_451323399/2655/2024-04-24T02:05:33