Inoculation & Precultures
The strains are provided by the customer.
Expert Live Microbial Product Manufacturing
For more than 18 years, Wacker Biotech has been a pioneer in the development and manufacturing of Live Microbial Products (LMP). Our Amsterdam site is home to our LMP center of excellence, with expertise producing drug products containing live microbes, including injectable immunotherapies, topical medicines, and live attenuated vaccines.
Contact usLMP Innovation and Expertise
Customers benefit from a broad range of GMP scales fitting the need of each project and development phase. We offer EMA/FDA-approved manufacturing lines ranging from 250 L single use to 1500 L stainless steel.
You also benefit from our unique LIBATEC® platform combined with our extensive experience with a wide variety of bacteria, including wild-type, genetically modified, aerobic and anaerobic strains. These bacteria can be used for a broad range of LMPs, including the FDA-defined class of Live Biotherapeutic Products.
Learn more about LIBATEC®LMP Capabilities
- Multiple Bacterial Strains
Experience and expertise spanning 20+ different strains, including:- Aerobic and anaerobic strains
- Strains up to, and including, BioSafety Level 2
- Spore formers
- Process Development
Support to develop your live microbial process – for example, replacing animal component-containing media and achieving high optical densities during fermentation. - Process Transfer and Optimization
Transfer of fermentation regimes for aerobic and specific anaerobic organisms. - Closed Production Systems
Monoseptic processing compliant with Annex I in order to maintain culture purity, crucial to meeting customers’ and regulators’ quality requirements. - GMP-Compliant Drug Substance
Manufacturing at various fermentation scales up to 1,500 L. - Analytical Capabilities for CBER-Compliant Quality Control
Comprehensive analytical portfolio for process and batch-release testing including Viable Cell Count (TCC), Total Cell Count (TCC), detection of potential contaminants, and detection of residual moisture (in the case of lyophilized products). Additional support for developing custom assays and methods. - Lyophilization and (Bulk) Drug Products
Edwards freeze drier (6 m2) for bulk lyophilization in vials or bulk up to 65 L, plus customized options such as for encapsulation.
Learn More about Our Experience with Different Bacterial Strains
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Key Benefits of Wacker Biotech as Your LMP Partner
- Process Development Support
With 18+ years of experience with many different strains requiring monoseptic processing, Wacker Biotech can develop a custom process that is fully compliant with regulatory requirements and your own quality standards. - Analytical Support
From development of your analytical methods to complete setup, the Wacker Biotech team can support you at every stage of your product’s lifecycle. - Flexibility
We tailor our services to your needs and offer a high degree of customization. - Annex 1 Compliance & Strong Regulatory Experience
Wacker Biotech has manufactured monoseptic processes for clients from diverse geographic locations, meeting the varying requirements of different regulators (e.g., EMA, FDA, Anvisa). Our deep knowledge of the market and regulatory landscape enables us to be your expert guide on your drug product journey. - Full Program Support
We have extensive experience in formulation and lyophilization development and are ready to collaborate with you on the development of your biopharmaceutical drug product.
Learn More about Wacker Biotech’s LIBATEC® Platform for Live Microbial Process Development and GMP Production
Wacker Biotech’s proprietary LIBATEC® (Li ve Ba cterial Tec hnology) platform enables manufacturing without hold times – a critical necessity when working with live organisms – and maintains cell viability throughout the production process. The platform is also perfectly suited for a wide variety of live microbial strains and fermentation regimes for both aerobic and certain anaerobic organisms.
Click orange dots to learn more about each process step
Fermentation
Leveraging Wacker Biotech's EMA/FDA-approved manufacturing lines (ranging from 250 L single-use to 1500 L stainless-steel fermenters) allows customers to adjust the scale of GMP processes to meet the needs of each project and development phase.
Yield & TFF
An existing centrifugation step is usually replaced with an ultra-/micro-filtration step using tangential flow filtration (TFF) This is also a disposable technology and ensures the process remains closed and monoseptic at all stages.
Drug Substance
Bulk drug stubstances can be dispensed into trays and lyophilized. Bulk lyophilization runs up to 65 L are supported.
Drug Product
Aseptic filling operations are carried out within Wacker Biotech's GMP fill & finish facility, which includes both a formulation/preparation area and a principal filling area.
Liquid Formulation or Lyophilization
Drug products can be dispensed into vials. Batch fills are possible up to 20,000 units (DIN 2R to 20R) for both liquid and lyophilized formulations.
Customer/Product Spotlights
- Customer: Aurealis Therapeutics
- Product: AUP1602-C genetically modified lactic bacteria for chronic wound applications
- Scope: Process development, scale-up and GMP manufacturing
Aurealis Therapeutics AG approached Wacker Biotech for process development, scale-up and GMP manufacturing of AUP1602-C, their lead candidate for chronic wound applications. Genetically modified lactic bacteria are administered topically to promote tissue regeneration in patients suffering from non-healing chronic wounds. Manufacturing under monoseptic conditions was required because the product will be in direct contact with human tissue.
The process was successfully transferred, adapted for monoseptic manufacturing under GMP conditions and scaled up. Subsequent manufacturing was performed under monoseptic GMP conditions using Wacker Biotech’s 250 L single-use bioreactor, followed by aseptic filling into ~4,000 vials per batch. The process developed was shown to be highly robust, yielding cells that are resistant to processing, hold times and storage at low temperatures. Cell viability of the resulting drug product met the defined criteria (1010 – 1011 colony forming units/mL). Wacker Biotech also performed setup, development and validation of the required analytical assays for product testing. The drug product was successfully released for use in phase I clinical trials, and a Phase II trial is now planned.
We are very pleased with the high technical competence, reliability and support of the Wacker team to bring our lead candidate into the clinic as planned – Wacker is a true partner in this project.
Juha Yrjänheikki, CEO of Aurealis Therapeutics- Customer: Prokarium
- Product: Genetically modified salmonella
- Scope: Process development and GMP manufacturing
For London, UK-based Prokarium, a pioneer in the field of microbial immunotherapy, Wacker Biotech is conducting GMP manufacturing of an oral biopharmaceutical for bladder cancer. Prokarium’s pipeline is leveraging the most recent advances in cancer immunology to take immuno-oncology to the next level. In particular, it uses genetically modified salmonella as a delivery mechanism for delivering anti-tumor payloads to bladder cells.
We are very pleased to work with Wacker Biotech given their deep expertise with live microbial products and GMP production.
Kristen Albright, PharmD, Prokarium’s Chief Executive Officer
Ready to Partner with Us?
Discover how Wacker Biotech can transform your biopharmaceutical production. Contact us today to learn more about our innovative solutions and how we can help you achieve your goals. Reach out to our team for more information.
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