Identifying the most appropriate contract manufacturer that is most likely the best match for your lead pharmaceutical candidate is a true challenge. Rentschler is a biopharmaceutical manufacturer with a proven track record for over 40 years. Focused on mammalian cell lines, our experience covers the development, production, and aseptic filling of recombinant proteins such as cytokines, enzymes, monoclonal antibodies, and fusion proteins in compliance with international GMP standards (EMA/FDA). We don’t just claim to be reliable and experienced; our many successful projects and long-lasting client relationships show that we are.
TurboCell™ Technology
Rentschler’s proprietary TurboCell™ platform enables the simultaneous production of up to 20 early stage drug candidate variants in stable CHO cell lines. TurboCell™ is a technology for the fast generation of highly stable recombinant mammalian (CHO-K1) cell lines based on cassette exchange (RMCE). The cassette allows the precise integration of the gene of in...
Sandoz is one of the leading specialists in biotech development and manufacturing. Comprehensive know-how is based on more than two decades in microbial and mammalian cell culture production at commercial scale. Today Sandoz offers a broad variety of integrated services, including innovative expression systems, process development, scale-up, and production of recombinant products derived from microbial systems and mammalian cell culture in state-of-the-art facilities.
Our expertise is based on numerous projects successfully performed in collaboration with our customers. Currently, Sandoz is manufacturing more than 25 different recombinant products for well-known pharmaceutical and biotechnology companies located in the United States, Europe, and Japan. Our FDA-approved facilities fulfill worldwide quality requirements.
Services Offered
Production of Recombinant Peptides and Proteins:
150-L, 1,300-L, 3,000-L, 13,000-L, and 40,000-L fermentors are available in our facility in Kundl, Austria. Each fermentat...
Contract manufacturing of biologics is more than having superior technology — it’s having experienced people who are passionate, responsive, and committed to developing and manufacturing your biotherapeutics to improve patient care. As a fully integrated contract development and manufacturing organization (CDMO), Therapure Biomanufacturing has the scientific and technical expertise to successfully deliver at every stage of product development (preclinical, clinical, and commercial). Our 130,000-ft
2
(12,000-m
2
) current good manufacturing practice (cGMP) manufacturing facility meets FDA, EMA, and HPFB regulatory standards and includes flexible clinical and commercial production suites.
Development Services
Therapure appreciates the complexity of the development process. Our range of services is supported by a deep scientific understanding of process and analytical development. Our development services include
Cell Line:
generation of well-characterized, stable mammalian cell lines
Upstream:
developmen...
Vetter, a leading provider of aseptically prefilled drug-delivery systems, operates a state-of-the-art facility at the Illinois Science and Technology Park in suburban Chicago. The site offers a central US location with a domestic and international airline hub. It is uniquely situated in a thriving biopharmaceutical region that offers an established infrastructure and prominent research institutions.
The company’s Chicago site supports preclinical through phase 2 development projects. The 27,000-ft
2
facility’s functional areas include microbiology and chemical analysis laboratories; materials preparation; compounding; aseptic CGMP filling for vials, syringes, and cartridges; quality assurance; and seamless transfer to Vetter commercial manufacturing.
DeveIoped at the urging of Vetter’s North American clients, the Chicago site supports small-batch, early stage products. Vetter has extensive experience working with biologics, including monoclonal antibodies, peptides, interferons, and vaccines.
Supporting...
Wacker Biotech GmbH is “The Microbial CMO” — the partner of choice for the contract manufacturing of therapeutic proteins in microbial systems. The company is built on more than 20 years of experience in biopharmaceutical manufacturing. Founded in 1999 as a spin-off from the Hans- Knöll Institute in Jena, Wacker Biotech is a 100% subsidiary of Wacker Chemie AG since 2005.
Wacker’s integrated service portfolio covers molecular biology, process and analytical development, and the GMP manufacturing of biologics for clinical trials and commercial supply. We round out our offering with outstanding Escherichia coli technologies that can significantly increase bioprocess efficiency and thus reduce cost of goods.
In 2014, Wacker acquired Halle-based Scil Proteins Production GmbH. The merger has leveraged complementary skills in the production of biopharmaceuticals, thus creating a strong and highly competitive microbial CMO. The acquisition has doubled our development and manufacturing capacities and has added va...
