Many large biopharmaceutical companies have the means to develop their therapeutics, conduct the manufacturing and prepare the regulatory submissions needed to advance these products to the healthcare marketplace. As the demand for new biotherapeutics continues to surge, however, small and mid-size biopharmaceutical companies need an experienced Contract Development and Manufacturing Organization (CDMO) that can help them accelerate their products from a concept to a treatment more than ever.

That’s a major reason why Tanvex BioPharma USA, Inc., is launching Tanvex CDMO, a pre-clinical-to-commercial, full-service CDMO specializing in mammalian- and microbial-derived biologics and biosimilars. Tanvex BioPharma USA has successfully advanced biologics from the Investigational New Drug Application (IND) stage to a Biologics License Application (BLA). Now as a CDMO, it aims to leverage its technical insight, regulatory knowledge and vertically integrated infrastructure to foster its clients’ biotherapeutics production and delivery.

More companies are focusing on cultivating biotherapeutics, but they face several steps and obstacles in moving their product from an idea to an approved drug used by healthcare systems. Typically, these companies are start-ups to med-size companies that lack all the necessary resources.

Tanvex CDMO immediately aims to serve biologics and biosimilar companies seeking to outsource their therapeutics development and Good Manufacturing Processes (GMP) services. Despite just recently launching, Tanvex already has the capacities, infrastructure and know-how to be an effective CDMO partner. Through its biosimilar development experience, the company has built strong product characterization and comparability analytical capabilities, as well as formulation expertise.

Tanvex has successfully developed and commercialized two multiple biologics derived from microbial and mammalian systems. One has been approved in Canada, and has additional BLA’s pending approval in the U.S., for example. It has also established key partnerships, including a drug product collaboration with a nearby fill/finish CDMO provider, and recently hired a few executives with extensive CDMO experience. Tanvex has also been on the innovator side of outsourcing partnerships, so it intrinsically understands what innovators are working through while developing their own products, what assistance they need and what they are seeking in an outsourcing partner.

Tanvex CDMO’s core service offerings include:

• Cell line development (mammalian and microbial)
• Microbial fermentation process development and optimization
• Mammalian cell culture process development and optimization
• Purification process development
• Analytical and potency assay development, and method qualification/validation
• Product and process characterization
• Pre-formulation and drug product formulation development
• GMP services for both mammalian- and microbial-derived therapeutics
• Quality control and lot release testing
• Stability study (protocol generation, storage and testing)
• Regulatory support

Tanvex CDMO’s location and facility also make it an attractive partner. It is based in the Sorrento Valley area of San Diego, a biotech hub, providing biotherapeutics companies there with convenient access to both development and manufacturing services. Tanvex is also one of the few west coast companies that conducts biologic or biosimilar manufacturing and has easy access to the Asian market—including its sister company, Tanvex Taiwan, which helps Tanvex understand how to work with Asia-Pacific region (APAC) companies as well.

Tanvex CDMO’s 100,000-square-foot campus includes a research & development (R&D) center, two mammalian GMP manufacturing suites, one microbial GMP manufacturing suite and quality check (QC) microbiology laboratories. The facility applies high-throughput workflows, the latest DOE statistical and data analysis software, single use technology and streamlined equipment to accelerate drug development. It has been inspected by the Food and Drug Administration (FDA) three times since 2019. Tanvex has over 160 skilled scientists with extensive IND and BLA regulatory filing experience working on-site to provide efficient and collaborative support for clients.

These attributes can really aid biotherapeutics developers. The high throughput technologies and DOE software allow Tanvex to maximize product knowledge while minimizing experimentation requirements, for example. The company also aligns equipment with manufacturing and QC to simplify process and method transfer.

Through every stage of product development, spanning pre-clinical and all three clinical phases, Tanvex offers the key services needed to assist biotherapeutics companies. It then aids with commercial production, continuous improvement activities and post-commercial regulatory compliance work during the commercial stage.

Then there are Tanvex’s program management capabilities. For each account, the company offers a designated manager, an internal team of SME’s accessible throughout the partnership and ad hoc technical calls when needed, and coordinated team meetings. Staff also track progress, timelines and budgets; and establish and share project governance structures.

In the long run, Tanvex CDMO aims to become a trusted biologics CDMO partner and establish itself as a premier CDMO. With its resources, knowledge and experience to build on, it has the potential to do so. More immediately, it is positioned to provide exceptional CDMO services to the growing number of biotherapeutics companies working in a healthcare marketplace demanding more of such treatments.

To learn more about Tanvex CDMO, visit www.Tanvexcdmo.com or https://www.linkedin.com/company/tanvex-cdmo/, or contact the company at CDMOsales@tanvex.com