Process & Analytical Development

Process development is the link between research and the subsequent commercial production of biopharmaceuticals. Its goal is to develop a cost-effective and robust manufacturing process that can be validated and yields maximum quantities of high-quality product, while complying with all process and product specifications.

With over 30 years of experience and more than 200 successfully accomplished projects for our customers across the globe, Wacker Biotech has the expertise to develop processes that satisfy customers’ demands for rapid availability of clinical materials, while bearing in mind the long-term demands of commercial production processes. We serve customers under the regulatory jurisdiction of the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and similar agencies of other regions including South Korea and Japan.

The BioProcess Development department with more than 80 full-time employees (the vast majority with academic degrees) is focused solely on process development, material supply for preclinical trials, strain/analytical development, process transfer and process characterization.

Fermentation Development

Wacker Biotech has built up a wealth of knowledge in the development of robust and efficient fermentation processes for production of biologics with microbial systems. We develop processes that operate at the scale of production required during clinical trials, but we will also focus on your long-term goals and plan your process with these in mind. Our expertise includes soluble expression and production of inclusion bodies as well as fermentation development for vaccine and live microbial processes.

Wacker Biotech has a well-established BioProcess Development department with a wealth of experience in microbial upstream development for all your biopharmaceutical types. Our robust fermentation processes can be validated and ensure high, reproducible yields up to 14 g/l.

Our services include:

Development of the entire fermentation procedure from the cell bank to the commercial fermentation process
Medium development and optimization (defined media)
Process optimization based on the physiological needs of the microorganisms
Process development for high-cell-density fermentation
Definition of key fermentation parameters
Validation of fermentation

Refolding Development

Refolding is the art of converting denatured and misfolded recombinant proteins back into their biologically active form. Wacker Biotech has an in-depth understanding of protein folding and the technical requirements of large-scale manufacturing.

Various physical parameters, additives and buffer components influence the outcome and efficacy of refolding processes. Selection and proper adjustment of these conditions is of utmost importance for the cost-efficient industrial manufacturing of biopharmaceuticals. Our integrated approach and constant communication throughout the entire development phase ensure that the subsequent process scale-up and cGMP requirements are taken into account.

Our services include:

Development of inclusion body preparation step based on our FOLDTEC^® system or on a customer’s system
Development and optimization of the refolding procedure based on our FOLDTEC^® system or on a customer’s system
Iterative screening to identify suitable conditions for in vitro folding of the target protein
Development of clarification step after refolding and conditioning to meet the requirements of the capture step in later DSP
Process optimization in terms of yield, process time and product quality
Validation of the refolding process

Purification Development

Efficient purification processes are the result of our employees’ experience, systematic selection of the chromatography media and filtration steps, and specification of chromatography parameters in direct liaison with the process development analytical team.

Our integrated approach and constant communication throughout the entire development phase ensure that the subsequent process scale-up and cGMP requirements are taken into account.

Our services include:

Development of the entire purification procedure from cell harvest to the final active ingredient
Selection and optimization of a suitable cell harvesting method (centrifugation, separation and cross-flow filtration)
Design, selection and optimization of a suitable purification method (chromatography instructions, media and scale, and filtration steps)
Process optimization in terms of yield and product quality
Optimization of the purification process based on process- and product-specific contamination to increase product quality and safety
Definition of key purification parameters
Validation of the downstream process including lifetime studies

Analytical Development

The development of your process is always accompanied by extensive analytical support. The instruments Wacker Biotech employs are validated according to current guidelines (including ICH) and the methods of analysis meet all international requirements and will be qualified/validated for the specific product development stage.

Wacker Biotech has a wide range of state-of-the-art analytical methods in-house as core expertise for the development of efficient, high-quality processes. We use analytical methods for product characterization and have a comprehensive set of analysis techniques for determining product- and process-related impurities at our disposal. A product-specific set of analytical procedures is developed for each product to monitor critical control points during the process and to comprehensively characterize the end product.

Plasma Half-Life Extension

Wacker Biotech has extensive expertise in the development and performance of the PEGylation step of biologics and synthetic peptides in our GMP facilities.

Product/Customer Spotlights

Development of a cancer drug from strain to approval

Customer: medac GmbH
Product: Spectrila^®, recombinant L-asparaginase, for treatment of acute lymphocytic leukemia (ALL)
Scope: Wacker Biotech developed the entire manufacturing process for the drug substance – recombinant L-asparaginase – from the initial cell line to commercial production.

Based on a production strain of Escherichia coli, the new WACKER process for Spectrila^® utilizes proprietary technologies such as high-cell-density fermentation. The WACKER contribution to the Spectrila^® drug substance approval covers biopharmaceutical process development in its entirety – from generating the cell line, to establishing and validating the analytical methods for process control and release of the bulk drug, to the final, validated, industrial-scale production process. Wacker Biotech now provides medac with the drug substance from its modern GMP facility in Jena for market supply of Spectrila^®. It obtained approval from the European Medicines Agency (EMA) in 2016 and from the FDA in 2018.

Development of a novel regenerative therapeutic for phase I/II

Customer: Caeregen Therapeutics
Product: Noregen™, a novel regenerative therapeutic for the treatment of retinal-related vision loss
Scope: As Caeregen’s CDMO partner for CTR-107, Wacker Biotech will produce drug substance at its site in Halle, Germany, and complete clinical trial drug product production at its site in Amsterdam, the Netherlands, to support Phase I/II clinical study initiation in 2024.

CTR-107 is the first program to obtain U.S. FDA Rare Pediatric Disease Designation for treatment of Familial Exudative Vitreoretinopathy (FEVR).

As a potential break-through program for a rare, devastating retinal disease with no therapeutic options for patients, we selected Wacker Biotech as our CDMO partner for CTR-107 development because of their long-standing experience and deep understanding of protein chemistry, and shared urgency in advancing transformative science.

Walter Capone, CEO of Caeregen Therapeutics

Development of a mRNA-based therapeutic

Customer: Pantherna Therapeutics
Product: PAN004, active ingredient based on mRNA and lipid nanoparticles (LNPs) for combating acute respiratory distress syndrome (ARDS)
Scope: Wacker Biotech developed large-scale production process and covers the entire production process – from starting material and plasmid DNA through to the mRNA LNP formulation and dispensed mRNA active.

We have established a very good collaborative R&D footing with WACKER and value its broad expertise in the production of mRNA active ingredients – expertise that we were able to use to turn our innovative technology into a product. WACKER plays a special role in the market, as it combines many years of experience in the toll manufacturing of complex biopharmaceuticals with the capabilities of its own Corporate R&D unit. We are delighted to now see our innovative mRNA active ingredient move from the laboratory to regulated production. This marks an important milestone for our company and opens a new chapter in our joint collaboration.

Dr. Jörg Kaufmann, CSO of Pantherna