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 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 valuable expertise in the refolding of insoluble proteins, thus expanding the service offer to suit all possible customers’ needs.

Facilities: Flexible and Approved

Our sites in Jena and Halle provide a complete range of services for the development and GMP-compliant manufacture of biopharmaceuticals using microbial hosts. Two manufacturing lines with 300-L and 1,500-L fermentation vessels and matching DSP scales are available to flexibly serve our clients. The proximity of Jena and Halle facilitates the exchange of know-how, and a combined team of approximately 160 experienced staff is committed to delivering superior solutions.

Wacker holds biomanufacturing certificates from the relevant authorities for both sites and follows ICH Q7A guidelines for GMP-compliant production of active pharmaceutical ingredients (APIs). Our quality systems are continuously assessed by a combination of internal, customer, and official audits. The GMP production facility in Halle received EMA approval for the commercial manufacture of Reteplase in 2012 and was successfully inspected by the FDA in the same year. The facility in Jena is scheduled to start commercial manufacturing of an API in 2015.

Technologies: Cutting Cost of Goods

Wacker offers cutting-edge proprietary technologies for the efficient and cost-effective production of biologics.

ESETEC® Proprietary E. coli–Based Secretion System: Wacker’s secretion system allows for the recovery of high yields of correctly folded proteins directly from culture broth, without the need of cell disruption or refolding. The technology has been successfully used to produce a broad variety of recombinant proteins, including therapeutic Fabs and scaffold proteins.

DENSETEC® Proprietary Technology for High–Cell- Density Fermentation: Wacker holds intellectual property for a high–cell-density fermentation technology that allows optimal volumetric productivity in robust and highly reproducible fermentation regimes.

In Vitro Folding: Using a matrix-based screening approach in combination with a proprietary expression vector portfolio, Wacker provides solutions for complex and challenging in vitro folding processes. The combination of better folding efficiencies with the reduction of the folding volume results in fully scalable manufacturing processes.

PASylation® Innovative Technology for Extension of Plasma Half Life: In collaboration with the German company XL-protein GmbH, Wacker offers the production of PASylated biopharmaceuticals using ESETEC®. Recently, PASylated Fabs were produced with yields >3 g/L.

Track Record: From Scratch to Commercial Batch

Wacker Biotech has an established track record and more than 20 years of experience in process design, process transfer, and manufacturing of therapeutic proteins for a vast number of customers ranging from small biotechnology companies to big pharmaceutical corporations. Wacker’s experience covers all aspects “from scratch to commercial batch” — from preclinical development to API delivery for market supply.

Dr. Silvana di Cesare is business development manager at Wacker Biotech GmbH, Hans-Knöll-Strasse3, 07745 Jena, Germany, 49-3641- 53-48-150; fax 49-3641-53-48-160; [email protected]; www.wacker.com/biologics.