Large Molecules & Biologics

Bioassays are essential for the development of new biopharmaceuticals. In particular, per regulatory requirement, they are performed to determine the biological activity or potency of the product, a critical quality attribute according to ICH Q6B.

Due to their complex nature, bioassays are one of the most challenging assays to perform. Therefore, consistent assay performance requires a controlled environment, skilled analysts with a thorough understanding of cell physiology and a well-developed and characterized method.

Bioassays for biopharmaceuticals

Applied methods and guidelines

In addition to various validated and customised bioassays, we have developed and implemented different methods for the characterisation of well-known biosimilars as patents on popular biopharmaceuticals have expired. The growing need for biosimilar development and analysis requires reliable testing capabilities and a regulated environment, which we can provide.

The regulatory guidelines recommend the performance of extensive and robust comparability studies on both physicochemical and functional characteristics between the individual biosimilar and its respective reference product.

Gene therapy products are a unique class of biopharmaceuticals that offer exciting potential to treat life-threatening or debilitating diseases. Like all biopharmaceuticals, critical quality attributes of gene therapy products need to be carefully assessed to ensure product safety and efficacy. Unlike traditional protein therapeutics, efficacy of gene therapy products depends on multiple coordinated steps, including efficient cell entry, expression of the gene of interest, and proper biological function of the protein. Consequently, a matrix approach involving multiple bioassays - such as an infectivity assay combined with one or more functional assay(s) - are often required to sufficiently characterize the products. Oftentimes, the complexity of the mechanism of action also leads to higher intrinsic variability in bioassays, making them the most challenging assays to implement in quality control.

Eurofins BioPharma Product Testing offers extensive experience in bioassay development, optimization, phase appropriate method validation/transfer, as well as assay maintenance to support routine lot release and stability testing.

Product Types

• Plasmid Vector
• Lentiviral Vector
• Helper Dependent Adenoviral Vector
• Adeno Associated Viral Vector (AAV)
• Retroviral Vector
• Oncolytical Viral Vector
• Viral Like Particles (VLP)

Assay Experience

• Viral vector TCID50 titration assay with qPCR and ddPCR readout
• Vector potency assay - transduction/transfection followed by gene expression and/or functional readout using qPCR/ddPCR, quantitative and binding ELISA, flow cytometry and enzymatic assays

Why Choose Eurofins BioPharma Product Testing?

• Unmatched expertise and proven track record for cGMP potency assay testing ensures successful and timely completion of your testing program.
• We have more experienced Ph.D.s than any other contract laboratory, including scientists dedicated to troubleshooting problematic assays and developing new assay platforms and methodologies.
• We offer a phase appropriate validation approach to meet early clinical stage, late clinical stage, and commercialization of your product.
• Our secure, 24/7 online data portal, LabAccess.com, provides timely access to your test results.

As patents on popular biological medical products begin to expire, there is an emerging need for reliable testing capabilities to support biosimilar development.

Regulatory guidance recommends that extensive and robust comparability studies be performed on both physicochemical and functional attributes between the biosimilar product and its respective reference/innovator product.

Eurofins BioPharma Product Testing network of laboratories is proactively expanding our offering of validated cell based potency assays that are ready to use to test biosimilar drug substance and drug product samples, as well as to assist process development and validation.

In addition to the cell based potency assays being developed in the US, we also have method development and testing capabilities at our laboratory in Munich, Germany for Surface Plasmon Resonance (SPR) assays—alternative methods to study the binding activity/affinity of the biosimilar products to their intended target (and/or Fc receptors), which are frequently adopted as additional functional characterization assays. Amongst others, our Munich lab has also developed and qualified a set of characterization assays that can be used for a comparative study of innovator Simponi^® and biosimilar product Golimumab.

We also collaborate with our colleagues in the US and Europe to transfer and co-validate methods to provide a global offering.

Comprehensive Services to Support Biosimilars

Our comprehensive offering of testing services enables us to support all aspects of your biosimilar development project, including:

• Full GMP Stability and Release Testing
• Biochemistry Characterization, meeting ICH guidelines (particularly ICH Q6B)
• cGMP Mammalian Cell Bank Manufacturing and Cell Line Characterization
• Viral Safety and Viral Clearance
• Lot Release for adventitious agents
• Microbiology
• Molecular and Cell Biology

Available Assays

*Full panels of GolimuMab assays are available at our site in Munich, Germany. The lot release assay will be transferred to our site in Lancaster, PA.

**We are sensitive to the unique needs of each of our biosimilar clients and will work with clients to prioritize development of a given method to support specific requests

Protein analysis for testing process-related impurities

Eurofins BioPharma Prouct Testing DACH offers testing of all process-related impurities such as residual protein A, DNA or host cell proteins (HCP) under GMP standards at its sites in Homburg and Munich.

In addition, for product-related substances/impurities, such as post-translational modifications, assays must be used to ensure that all impurities present are below the specified acceptable levels.

To this end, we have established analytical methods such as ELISA, MSD, chromatography and capillary electrophoresis techniques in the Eurofins BioPharma Product Testing Network of Laboratories. Physical and chemical tests, i.e. pH, appearance, osmolality or particles, complete the package of protein analytical tests we can perform for you.

The importance of Extractables and Leachables

Extractables and leachables (E&L) studies enable drug sponsors to quantify and identify the risks of potentially toxic leachable impurities migrating into a drug solution from container closure systems, processing equipment or packaging. Extractables & leachables testing services play a pivotal role in ensuring the safety and quality of healthcare products. A proper evaluation is a key requirement for most regulatory bodies, including FDA and EMA.

The heightened and increasing demand for biopharmaceutical medicines has resulted in greater demand for E&L testing in drug safety, such as when mitigating cross-contamination risks.  Companies will have to sharpen their understanding of evolving E&L regulatory expectations in order to remain compliant - Industry testing experts play a crucial role in achieving success.

Trusted leader in Extractables and Leachables testing

With a strategic focus on quality and reliable services, we have established the most complete variety of extraction and testing options to meet your extractables and leachables needs. Through the provision of well-engineered and innovative testing solutions, we have gained the confidence of international manufacturers and regulatory agencies.

With over 15 years of experience, we offer the highest standards on extractables studies on primary packaging, medical devices, biologics, single-use systems (SUS) and other consumables used in the pharmaceutical manufacturing chain (filters, tubes connectors,ecc), as well as leachables testing in the final product. Thanks to our dedicated team of 40+ expert toxicologists and consultants, we can address all the issues associated to toxicological safety assessment. 

Our dedication on offering exceptional testing services, fuels our commitment to contribute on the best practices and strategies to increase the efficacy in extractables and leachables testing. Let us develop with confidence your next project!

Discover the advantages of partnering with us for your regulatory success.