Analytical Methods for Biologics
Over the past few decades, the healthcare landscape has undergone a massive shift towards biopharmaceutical drugs. Biologics now represent a major class of modern therapeutics and their share continues to increase relative to traditional small molecule drugs. Despite this growth, the significant costs associated with efficiently discovering biological materials and developing them at a commercial scale can limit R&D efforts. This is particularly true for companies that lack the capacity and know-how to develop and execute the necessary analytical methods for biologics in-house.
This is just one of the reasons why Avomeen is an invaluable partner for biologics analysis. Along with access to our purposefully equipped labs, our team has significant expertise in all stages of biologics R&D; from early discovery through IND, BLA, and beyond. For each unique project, our team brings a combination of in-house protein biochemistry, molecular biology, cellular biology, and QC experience. This enables rapid design and development of robust cellular potency or in vitro efficacy methods to help obtain the pivotal data necessary for regulatory submissions and release testing. In partnership with our clients, we work to accelerate R&D efficiency and breakdown roadblocks when they need us most.
Our Biologics Analysis
Peptides – With properties that land somewhere between small molecules and proteins, peptides have a long history in human medicine. They also have their own bioanalytical challenges, particularly bioavailability and peptide stability. Avomeen understands the unique challenges associated with determining peptide purity and potency and can help you investigate your molecules stability through forced degradation studies.
Proteins & Enzymes – Proteins and enzymes can be used for an incredibly diverse set of therapeutic functions, from replacement therapies to diagnostics. Avomeen offers standard analytical services such like extra characterization, forced degradation studies, peptide map analysis, product-related and process-related purity analyses, specific activity, in vitro cellular uptake method development/validation, and more!
Monoclonal Antibodies (mAbs) – Monoclonal antibodies represent the fastest growing class of protein therapeutics. Given their clinical (and economic) significance, Avomeen has devoted special resources and techniques to mAb bioanalytical testing.
Gene Therapy & AAV Vectors – Biotechnological advancements in the past two decades have made room for safer and more effective gene therapies, many of which use adeno-associated viruses (AAV) as viral vectors. However, determining viral vector purity and transduction efficiency remains a significant analytical challenge for many innovators. Here, Avomeen can help companies develop the right method for each unique AAV product using our Protein Simple capillary electrophoresis system, UPLC capabilities, and cell culture facility; all while keeping clinical safety at the forefront.
Biosimilars – As biopharmaceutics continue to grow in emphasis and importance, an increasing number of FDA-approved innovator biologics’ patents will expire. As a result, biosimilar development will expand significantly. While these materials can reach the market rapidly, there are challenges associated with proving the similarity of these new product to the originally approved innovator drug. Avomeen understands the emerging potential biosimilar development holds and knows how to efficiently compare biologics to determine similarity. If you’re interested in partnering on biosimilar development, speak to Avomeen to find out more about our capabilities.
Biological Testing Capabilities:
We work with our partners to determine what assays, methods, and instruments will best help them reach their goals. This may include:
- Amino acid analysis
- Western Blot
- PK/PD method development
- Peptide map
- Protein identification services
- Forced degradation studies
- Cellular potency/efficacy and toxicity
- Specific activity method development
- Enzyme kinetics method development
- Glycosylation determination
- Post-translational modification determination
- Host cell protein impurity detection
- Cell culture media validation
- Viral particle titer determination
- AAV purity
- Transduction efficacy
- Concentration/yield determination
- Purity assessment
- Process impurity detection
- Trace metal analysis
- Serology test development
- Capillary electrophoresis (CE, Protein Simple Maurice)
- Ultra-performance liquid chromatography (UPLC, Agilent) with ELSD, UV-DAD and FLD
- High-performance liquid chromatography (HPLC, Agilent) with UV-DAD, Sedex, Varian, ELSD
- Dionex ICS-3000 Ion Chromatography System
- Seivers Total Organic Carbon Analyzer
- Agilent 7500ce ICP-MS
- AB Sciex Triple Quadrupole API 2000 and 3000 Mass Spectrometers
- Waters Acquity UPLC with Xevo G2-S Quadrupole Time of Flight (QTOF)
- Mammalian cell culture facility
- Caron stability chambers (custom settings)
- Metrohm 899KF Karl Fisher Coulometer
- Perkin-Elmer Spectrum 65 and Spectrum 100 Fourier Transform Infrared Spectrometers (FTIR)
- Perkin Elmer Lambda 365 UV/Vis Spectrophotometer
- Fluorescent & UV plate readers
In addition to a litany of analytic tests and capabilities, Avomeen has the cell culture facility and know-how to test your biologic products in clinically relevant bioassays. Our team can help develop and optimize bioassay methods that accurately collect data reflecting your biomolecule’s functional potency, thereby improving discovery efforts.
Regardless of your challenges, Avomeen is the partner you need to advance your biologics analysis. So, whether you are at the beginning stages of discovery or ready to formulate, give us a call!