Inoculation & Precultures
The strain(s) for the production of polysaccharide(s) are provided by the customer for the initial production step.
Expert Vaccine Manufacturing
Wacker Biotech is your CDMO partner of choice for the process development and manufacturing of a diverse array of vaccines, ranging from live, attenuated, inactivated and (conjugated) polysaccharide vaccines, to protein and mRNA-based vaccines.
Contact usVaccine Innovation and Experience
Wacker Biotech has more than 30 years of experience manufacturing conventional vaccines using microbial hosts for various infectious diseases. We are proud to have partnered with clients to bring several commercial programs to market that continue to protect populations worldwide.
More recently, after years of research, we have developed the expertise to produce next-generation mRNA-based vaccines and have built a center of competence in Halle, Germany with four new dedicated lines for mRNA production. The state-of-the-art center was partially funded by the German Government as part of its Pandemic Preparedness program.
Vaccine Capabilities
- Customized Process Development
A dedicated process development lab to support feasibility, process development and optimization as well as comparability. - Technology Transfer
Flexible and experienced MSAT teams to accommodate your customized protein processes. - Analytical Capabilities
Comprehensive analytical portfolio for product release, cell-based assays and stability studies. - GMP Cell Banking
Master and working cell bank production. - GMP Manufacturing
Scalable production from 250 L to 1,500 L scale for BSL 1 and 2 products for clinical trials or commercial supply. Learn more about our state-of-art production facilities. Link to Manufacturing
Vaccine Types
- Live, attenuated vaccines
- Inactivated vaccines
- Polysaccharide (conjugated) vaccines
- Protein-based vaccines
- mRNA-based vaccines
Experience with Diverse Bacterial Strains
- Escherichia coli
- Corynebacterium diphtheriae
- Haemophilus influenza B
- Klebsiella oxytoca
- Neisseria meningitidis A, C
- Pseudomonas aeruginosa
- Salmonella typhi
- Saccharomyces cerevisiae
- Vibrio cholerae
Key Benefits of Wacker Biotech Vaccine Services
- Versatile Capabilities across Multiple Sites
EMA/FDA-approved sites for GMP vaccine manufacturing at scales up to 1500 L in Amsterdam, plus capabilities to produce 200 million next-generation mRNA vaccine doses annually in our new mRNA Competence Center in Halle. - A Partner who Delivers
A total of +750 GMP batches of vaccines released for clinical (phase I to III trials) and commercial applications. - Biosafety
State-of-the-art biosafety level 1 (Halle, Jena) and 2 (Amsterdam) facilities, as well as an explosion-proof room (Amsterdam) for manufacturing vaccine products under strict ICH and GMP quality guidelines. - Diverse Scales
Scales range from single use reactors accommodating volumes up to 250 L, to stainless-steel fermenters with capacity from 350L up to 1,500 L. - End-to-End Upstream and Downstream Services
Efficient solutions for customer-specific process development, transfer, characterization and validation, complemented by tailored analytics for quality control.
Learn More about Conjugated Polysaccharide Vaccine Production
Fermentation
Leveraging Wacker Biotech’s EMA/FDA approved manufacturing lines (fermenter capacities ranging from 250 L single-use to 1,500 L stainless steel reactors) allows customers to adjust the scale of GMP processes to meet the needs of each project and development phase.
Purification
Purification of the polysaccharide from the fermentation broth usually includes several steps, such as:
• Centrifugation of the pathogen after chemical/thermal inactivation
• Concentration of intermediate product by ultrafiltration and/or depth filtration
• Precipitation of the polysaccharide using inorganic salts and/or organic solvents (explosion-proof rooms and equipment required)
• Chromatography steps
Lyophilization
Conjugating the purified polysaccharide to a carrier protein involves dispensing the polysaccharides into LYOGUARD® trays for lyophilization. Bulk lyophilization runs of up to 65 L are supported.
Activation
The bulk lyophilized polysaccharides are activated through a chemical activation step.
Conjugation
In the final step, the activated polysaccharides are chemically conjugated to the carrier protein(s).
Product/Customer Spotlights
- Customer: PaxVax
- Product: Vaxchora®
- Scope: Commercial GMP manufacturing
At our Amsterdam site, we manufactured Vaxchora®, a live, attenuated oral cholera vaccine for the commercial market for customer PaxVax (since acquired by Emergent BioSolutions). Oral vaccines are now the standard for helping to prevent cholera disease after injectable vaccines were discontinued in the 1970s when they were found to cause too many side effects.
Approved by the FDA in 2016, Vaxchora® is for those 2 to 64 years of age who are traveling to an area where the disease is endemic. It is the only cholera vaccine approved in the United States and has also been approved by the European Medicines Agency (EMA).
Vibrio cholerae is a species of Gram-negative, facultative anaerobe bacteria that frequently causes intense and fatal diarrhea and vomiting. Our state-of-the-art facilities were ideal to conduct the fermentation for this bacterium in a monoseptic, Biosafety Level 2 environment.
- Customer: MinervaX
- Product: GBS Vaccine
- Scope: Technology transfer, process characterization, process validation and GMP production for Phase III clinical supply
Denmark-based MinervaX recently answered the call of the World Health Organization to develop a vaccine for Group B Streptococcus (GBS), a bacterium that can cause life-threatening infections in infants, pregnant women and older/at risk adults. It is linked to half a million pre-term births annually. Not only will a vaccine save lives, but it will also alleviate the need for excessive use of antibiotics, which can lead to antibiotic resistance.
Arising out of research conducted at Lund University, MinervaX’s lead vaccine candidate is a novel protein-only vaccine, based on fusions of highly immunogenic and proactive protein domains from selected surface proteins of GBS. Wacker Biotech will produce a supply of the active protein ingredient for clinical Phase III clinical testing. Our vaccines center of excellence in Amsterdam will also perform technology transfer, process characterization and process validation for later-stage commercial manufacturing.
Wacker Biotech is a robust manufacturing partner with a strong track record in late clinical and commercial supply and we look forward to collaborating with the team ahead of commencing Phase III studies.
Per Fischer, CEO of MinervaX
