Explore Our Analytical Testing Services
No matter where you are in your biologics development journey, early clinical to late-stage commercialization, you need reliable, high-quality analytical data to move forward with confidence. Our full-spectrum analytical testing services are designed to meet your evolving needs, from early to late stage clinical and beyond.
Using advanced techniques like HPLC/UPLC, mass spectrometry, PCR, and more, we ensure your testing is aligned with cGMP, ICH, and FDA guidelines, so you're always prepared for regulatory submission.
Whether you're developing recombinant proteins, monoclonal antibodies, vaccines, or cell and gene therapies, our experienced team helps you streamline each phase with data you can trust and flexibility that supports your specific goals.
"Host cell proteins are an inevitable impurity of biopharmaceuticals. Even after multiple sophisticated purification steps, HCPs remain or co-purify with the drug substance. To protect patients from adverse effects, such as immunogenicity, powerful and reliable analytical tools are required to monitor such impurities during the manufacturing process and in final release testing."
Olaf Stamm, Technical Business Development Director
Analytical Testing Regulatory Requirements
Learn more about selecting the right analytical testing methods for regulatory approval.
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Contract Analytical Services
Product Characterization
Our GMP-compliant program includes method development, qualification, validation, and in-depth characterization of physico-chemical properties and general attributes using advanced techniques like UHPLC, electrophoresis, Western blot, and ELISA.
- Protein Characterization Services
- Reference Standard Characterization
- Potency Assays
- Mass Spectrometry Services
Lot Release
Meeting stringent regulatory requirements for product release is critical. We provide rigorous, cGMP-compliant drug substance and drug product lot release testing for the EU, US, and other regulatory markets, and are a one-stop site for global release testing. You can count on fast, reliable results that help keep your product release timelines on track.
Process Characterization
We identify and quantify a wide range of process and product-related impurities (e.g., IPTG, E1a, PEI, kanamycin, HCPs, host cell DNA). Through method optimization and advanced techniques, we ensure compliance with cGMP and ICH guidelines, helping you maintain robust manufacturing processes, enhance product safety, and meet regulatory requirements.
Stability Testing
Our stability testing services are designed to assess the shelf life and quality of your biologic products under various conditions and at designated time intervals. We offer a full range of stability testing services, including real-time, accelerated, and long-term stability testing to support your regulatory filings and ensure product quality throughout its lifecycle. We also offer forced degradation studies for early drug development processes.
Biologics Analytical Services Facilities
Learn more about our global site capabilities for contract analytical services.
Frequently Asked Questions (FAQs) About Biologics Analytical Services
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When do I need to conduct a full validation of my methods?
Full validation is required for phase III products when the manufacturing and purification processes are fixed and well established.
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Why do analytical methods need to be validated?
The analytical methods used in product testing must be validated to show acceptable levels of accuracy, precision, sensitivity, and reproducibility.
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Do I need to validate my characterization methods?
It depends on the methods' purpose and the stage of product development. For example, mass spectrometry used for characterization typically doesn’t require validation due to its nature.
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What critical quality attributes should be included in my release panel?
The release panel should include safety, quality, purity, identity, and potency as critical quality attributes.
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What method types are needed in a release panel?
The required methods depend on the product type but typically include compendial, non-compendial, and potency test methods.
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When do I need to have stability data?
Stability studies should begin as early as possible to establish shelf life and assess how the product changes over time during storage. This data is crucial for ensuring product safety for patients during clinical trials.
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Does a stability program require the same panel of methods as the release panel?
The release panel is used only at time 0 (T=0) of the stability program. Subsequent time points are analyzed using stability-indicating methods instead.