We are delighted to welcome Bioassay GmbH, a globally recognized provider of bioanalytical and quality control testing services, to the Contract Laboratory – The Laboratory Outsourcing Network. Based in Germany, Bioassay GmbH brings decades of expertise, a strong regulatory focus, and advanced bioanalytical capabilities to the pharma, biotechnology, and life sciences industries. Operating under good manufacturing practice (GMP) standards and ICH guidelines, Bioassay GmbH ensures that every result meets the highest levels of accuracy, reliability, and compliance.
About Bioassay GmbH
With a deep commitment to quality and regulatory excellence, Bioassay GmbH is a trusted partner for pharmaceutical and biotech companies worldwide. Their client-centric approach and advanced laboratory infrastructure allow them to deliver tailored solutions for complex bioanalytical challenges. This GMP-compliant laboratory integrates stringent quality assurance (QA) protocols into every project, ensuring that all testing meets the rigorous standards required by regulatory authorities.
By combining technical expertise with high-end facilities, Bioassay GmbH supports its clients at every stage of the drug discovery and development lifecycle, from method development to stability studies.
Testing Services Provided
Bioassay GmbH offers a comprehensive range of testing services designed to address critical needs in drug development, manufacturing, and QA:
1. Cell-Based Assays and Potency Testing
Specializing in cell-based assays, Bioassay GmbH evaluates the biological activity of pharmaceuticals, ensuring safety and efficacy. Their potency testing services are meticulously designed to comply with GMP standards and meet regulatory requirements for batch release and stability studies.
2. Method Development and Validation
Their team excels in developing and validating analytical methods tailored to meet regulatory requirements. These custom methods are optimized for precision, efficiency, and compliance with ICH guidelines, supporting batch release, product development, and regulatory submissions.
3. Biosimilar Comparability Testing
For companies developing biosimilars, Bioassay GmbH offers comprehensive comparability testing to demonstrate equivalence with reference biologics. This includes detailed potency, structural, and functional analyses, ensuring compliance with global regulatory frameworks.
4. Immunogenicity Testing
Using advanced immunoassays, Bioassay GmbH performs immunogenicity testing to detect and measure anti-drug antibodies (ADA). This critical service ensures that biopharmaceuticals maintain their safety and efficacy throughout their lifecycle, supporting regulatory submissions and post-market monitoring.
5. Stability Studies
They also provide stability studies in line with ICH Q1A guidelines, evaluating the shelf life, potency, and degradation of pharmaceuticals under various storage conditions. Their expertise ensures accurate results, supporting regulatory compliance and product lifecycle management.
6. Contaminant Detection
This laboratory specializes in detecting contaminants, including endotoxins, mycoplasma, and microbial impurities, to ensure the safety and purity of biopharmaceutical products. Their GMP-certified methods guarantee international standards compliance, minimizing risks for their clients.
7. Customized Testing Solutions
Above all, they work closely with clients to develop bespoke testing protocols that address unique project requirements. Whether for niche bioanalytical challenges or routine quality control, their tailored solutions reflect their commitment to innovation and client success.
Why Bioassay GmbH?
Bioassay, a Reaction Biology Corporation, offers GMP potency assays and functional bioassays, both in vitro and in vivo, as well as GLP-compliant services. Through their sister company PSL, Peptide Synthesis Services, they also provide peptide-specific antibody production and neoantigen synthesis.
With a strong foundation in GMP compliance, advanced testing capabilities, and a commitment to client success, this lab is well-positioned to support businesses in tackling complex regulatory landscapes and delivering high-quality, compliant products to market.
Want to outsource your testing needs to Bioassay GmbH? Simply submit a lab request here and their team will take care!
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