Process 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 20 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 on commercial production processes. We serve customers from the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and other regions including South Korea and Japan. The BioProcess Development department with more than 50 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.
Our strain development services include:
- Design and optimization of host/vector systems
- Customized improvement of expression systems (vector optimization, alternative induction principles and expression systems)
- ESETEC® proprietary E.coli secretion system: highly expressive plasmids and special E.coli K12 strain
- FOLDTEC® proprietary E.coli folding system: highly productive refolding of proteins
- Genetically-stable production 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
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
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
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.
Wacker Biotech develops and validates the manufacturing process in accordance with EU requirements as defined in ICH Q8 to Q11. The BioProcess Development department is equipped to perform comprehensive process development and characterization activities. The procedures ensure reproducible process performance and consistently high product quality.
As a result, controls are defined that include:
- Parameters and attributes related to drug substance and drug product
- Materials and components
- Facility and equipment operating conditions
- In-process controls
- Finished product specifications
- Methods and frequency of monitoring and control
8 x 15 L Biostat bioreactors for upstream process characterization.
Decades of experience in project management, expertise and efficient infrastructure are the basis for successful cooperation and the manufacture of biopharmaceuticals that meet the highest quality demands.
We always work in close collaboration with our customers. Our aim 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 Bioprocess Development, Quality Control, Quality Assurance and GMP Manufacturing departments.