originally published at Health - Purple Foxy LadiesNew biologics outsourcing solution provider leverages proven track record of Tanvex BioPharma USA Inc. to help early-stage companies bring mammalian and microbial derived biologics from concept to commercialization.
SAN DIEGO, October 16, 2023 (Newswire.com) - Tanvex BioPharma USA Inc., a developer and manufacturer of biopharmaceuticals, has launched Tanvex CDMO to provide comprehensive biologic contract development and manufacturing services, offering its experience and expertise to the biopharmaceutical industry.
Tanvex CDMO is an end-to-end biologics outsourcing solution provider located in the heart of San Diego's Sorrento Valley biotech hub. Its 100,000-square-foot facilities include a state-of-art R&D center, two (2) mammalian GMP manufacturing suites, one (1) microbial GMP manufacturing suite, QC laboratories and GMP warehouse. Tanvex CDMO uses high-throughput workflows to accelerate process development and formulation development. Its GMP facilities have been inspected by the U.S. Food and Drug Administration (FDA) and is equipped with single-use technology.
Tanvex CDMO aims to become a strategic partner to help biopharmaceutical companies advance their products from concept to treatments for patients. Its skilled employees have successfully taken multiple biologics from IND to BLA.
“Our launch of Tanvex CDMO is a testament to our unwavering commitment to advancing biologics development and manufacturing,” said Chief Operating Officer John Mosack. “With state-of-the-art facilities and an experienced team in development and manufacturing, Tanvex CDMO embodies the future of biopharmaceuticals, driving innovation to deliver life-changing biologics to patients worldwide.”
Tanvex CDMO offers the following suite of services:
- Cell line development (microbial & mammalian)
- Microbial and mammalian process development, optimization and scale-up
- Analytical development and phase appropriate qualification/validation
- Potency assay development
- Pre-formulation and drug product formulation development
- Clinical to commercial scale microbial and mammalian GMP manufacturing
- QC release testing and stability
- Regulatory support
With its in-depth knowledge of biologics development, cutting-edge facilities, and commitment to innovation, Tanvex CDMO is ready to serve the global biopharmaceutical communities and help deliver groundbreaking treatments to patients who need them.
About Tanvex CDMO
Tanvex BioPharma USA Inc. (formerly La Jolla Biologics, Inc.) was founded in 2011 with the mission of making biologics more accessible to patients. The company has successfully brought its first product to approval in Canada, and additional BLAs are pending approval by the FDA. Tanvex BioPharma USA Inc. now offers its technical and operational experience in making microbial and mammalian derived biotherapeutics to a greater audience by becoming a Contract Development and Manufacturing Organization - Tanvex CDMO. Tanvex CDMO brings together biologic drug substance and drug product development, GMP manufacturing and regulatory support services to foster a seamless collaboration experience for our clients while maximizing operational efficiency at every step of the drug development process to accelerate our client’s product from concept to treatments for patients.Contact Information:
Sr. Manager - Marketing
Tanvex CDMO Delivering a Shared Vision
Original Source: Tanvex CDMO Launch Empowers Advancements in Novel Biologics and Biosimilars