Author Archives: Silvana Di Cesare

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The Microbial CMO: Discovering Expertise in a New Scale

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…

Scale Up on Efficiency in Biologics Contract Manufacturing

Wacker Biotech is a dedicated contract manufacturer of biopharmaceuticals with over 20 years of experience in microbial systems. Our customers benefit from a comprehensive service for the development of robust and highly efficient production processes and GMP-compliant manufacturing for clinical trials and commercial supply. Service Wacker Biotech’s services cover the whole process chain: from construction and optimization of host/vector systems to delivery of the bulk API. A well-equipped quality control department supports characterization of master and working cell banks and…

High-Yield Production of PASylated Human Growth Hormone Using Secretory E. coli Technology

Since the 1985 approval of the first recombinant human growth hormone (hGH, such as Protropin/somatrem human growth hormone from Genentech, now Roche), the number of clinical indications for therapy with hGH has steadily increased (1). That led to a highly successful drug with more than US$3 billion sales in 2011 (2). Even so, hGH shares a common problem with most other first-generation protein therapeutics: a very short plasma half-life of just about two hours in humans. Because such biologics are…

Scale Up on Efficiency in Biologics Contract Manufacturing

      Wacker Biotech is a dedicated contract manufacturer of biopharmaceuticals with more than 20 years of experience in microbial systems. We offer proprietary technologies (ESETEC®, DENSETEC®) that significantly lower the cost of goods. Our customers benefit from a comprehensive service for the development of robust and highly efficient processes and GMP-compliant manufacturing for clinical trials and commercial supply. We opened recently a new process-development unit to optimize the entire process-development chain, from gene to purified protein. A second…

Scale Up on Efficiency in Biologics Contract Manufacturing

Wacker Biotech is a dedicated contract manufacturer of biopharmaceuticals with more than 20 years of experience in microbial systems. We offer proprietary technologies (ESETEC®, DENSETEC®) that significantly lower the cost of goods. Our customers benefit from a comprehensive service for the development of robust and highly efficient processes and GMP-compliant manufacturing for clinical trials and commercial supply. We opened recently a new process-development unit to optimize the entire process-development chain, from gene to purified protein. Asecond extension at the Jena…