CREATING TOMORROW S SOLUTIONS BIOPHARMACEUTICALS I CONTRACT MANUFACTURING WACKER BIOTECH: THE MICROBIAL CMO

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1 CREATING TOMORROW S SOLUTIONS BIOPHARMACEUTICALS I CONTRACT MANUFACTURING WACKER BIOTECH: THE MICROBIAL CMO

2 STATE-OF-THE-ART GMP FACILITIES Our sites in Jena and Halle (Germany) provide a complete range of services for the development and GMP-compliant manufacture of biopharmaceuticals using microbial hosts. Two manufacturing lines with 300-liter and 1,500-liter fermentation vessels and corresponding DSP capacities are available to flexibly serve our clients. The proximity of Jena and Halle facilitates the exchange of know-how, and a team of approx. 200 experienced staff delivers superior customer service with tailor-made solutions. ESETEC and FOLDTEC are registered trademarks of Wacker Chemie AG. WACKER holds biomanufacturing certificates from the relevant authorities for both sites, and follows the ICH Q7A guidelines for GMPcompliant 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 commercial manufacturing in 2012 and U.S. FDA approval in The GMP facility in Jena has been approved by EMA in 2016.

3 A DEDICATED BIOLOGICS CONTRACT MANUFACTURER Wacker Biotech GmbH is THE MICROBIAL CMO the partner of choice for the contract manufacturing of therapeutic proteins in microbial systems. Integrated Service Portfolio WACKER s services cover molecular biology, process and analytical development, and the GMP manufacturing of biologics for clinical trials and commercial supply. We offer our customers added value with outstanding E. coli technologies that significantly increase the bioprocess efficiency and so reduce the cost of goods. 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 corporates. Our experience covers all aspects from scratch to commercial batch, namely projects from preclinical development to drug substance delivery for commercial supply. We have completed more than 125 customer projects. More than 20 Years of Experience Founded in 1999 as a spin-off from the Hans-Knöll Institute in Jena, we have been a 100% subsidiary of Wacker Chemie AG since Biopharmaceutical manufacturing in Jena already started in the early nineties. In 2014, we rounded off our portfolio by acquiring Hallebased Scil Proteins Production GmbH.

4 EFFICIENT PROJECT MANAGEMENT Excellence in project management is key to the success of a project. For this reason, professional and dedicated project management is our top priority. Decades of experience in project management, know-how and efficient infrastructure are the basis for successful cooperation and for manufacturing products that meet the highest quality demands. Each project is unique and requires an individual approach. We are firmly focused on customer requirements and are sufficiently flexible to take on projects at any phase. We always work in close collaboration with our customers. Our work to achieve clearly defined and realistic targets is based on open and continuous communication. A dedicated project manager ensures focused and efficient project execution. Project managers are supported by teams of experts from the process development, quality control, quality assurance and production departments. For more information, please visit our website

5 CUTTING-EDGE TECHNOLOGIES Wacker Biotech offers innovative proprietary technologies for the efficient and cost-effective production of biologics: ESETEC : E. coli Secretion Technology WACKER s unique secretion system allows for high yields of correctly folded proteins in the culture broth. It comprises an engineered E. coli K12-based host strain, a set of proprietary plasmids, and a genetic toolbox to increase secretion. The technology has been successfully used for the production of a broad variety of recombinant proteins, including therapeutic Fabs, scaffolds and single domain antibodies with yields up to 14g/L. With straightforward strain and process development and 3 times lower COGS, ESETEC is a costand time-efficient alternative for mammalian systems. FOLDTEC : E. coli Folding Technology While WACKER s own ESETEC technology has proven highly efficient in producing soluble proteins via secretion, poorly soluble substances form aggregated inclusion bodies within the cell. Here protein refolding is a key production stage in order to achieve the desired active properties. The FOLDTEC technology is based on proprietary E. coli strains optimized for high-quality inclusion bodies and superior yields (up to 12 grams per liter). Complemented by our years of experience in refolding and a tailored screening approach, FOLDTEC offers better efficacies, smaller folding volumes and fully scalable manufacturing processes without the need for antibiotics or undesired phage components. In synergy with WACKER s high-cell-density fermentation systems, FOLDTEC provides unique solutions for the sophisticated manufacturing of biopharmaceuticals by refolding. 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 > 4 g/l.

6 The data presented in this medium are in accordance with the present state of our knowledge but do not absolve the user from carefully checking all supplies immediately on receipt. We reserve the right to alter product constants within the scope of technical progress or new developments. The recommendations made in this medium should be checked by preliminary trials because of conditions during processing over which we have no control, especially where other companies raw materials are also being used. The information provided by us does not absolve the user from the obligation of investigating the possibility of infringement of third parties rights and, if necessary, clarifying the position. Recommendations for use do not constitute a warranty, either express or implied, of the fitness or suitability of the product for a particular purpose. 7093e/07.17 replaces 7093e/05.17 Wacker Biotech GmbH Jena and Halle, Germany Tel info.biologics@wacker.com