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Therapeutic Protein Characterization

Therapeutic Protein and Enzyme Analysis

Given the critical role of proteins and enzymes in human health and disease, it’s no surprise that this class of therapeutics plays a dominant role in modern medicine. Relative to small molecule drugs, proteins offer more complex mechanisms, limit off-target effects through specificity, and are often well-tolerated. They can also be used as diagnostic biomarkers.

While a lot of investigational protein and enzyme therapeutics qualify for orphan disease or fast-track regulatory pathways, the need for streamlined, cost-efficient analytics remains. Complications with protein solubility, stability, distribution, and administration route are relatively common and can cause expensive delays. To mitigate these challenges, Avomeen uses a variety of refined protein characterization assays, alongside specialized tools for quantification, stability analyses and more. We can also help you identify issues that are unique to peptide and enzyme therapeutics, such as post-translational modifications (PTM) and enzyme kinetics.

Note: While this section focuses on analytical services for protein/enzymes, it does not include information pertaining to monoclonal antibodies (mAbs). Due to their special importance and general differences to other protein classes, Avomeen’s antibody therapeutics offerings can be found separately. See here for our monoclonal antibody analytical services.

Avomeen brings:

Expertise to tackle routine and specific therapeutic challenges, from enzyme kinetics to cellular potency testing. Strategic method development, to optimize processes, yield, and purity prior to large-scale manufacturing. Guidance around the data and documentation you need to show long-term safety at the preclinical level.

Let’s Talk Specifics

Protein Analytics Capabilities:

We work with our partners to determine the best analytical strategy to help them reach their goals. We offer drug substance characterization for IND and BLA, analytical method development, forced degradation studies, stage-appropriate method qualification, stability program, impurity identification, and product quality investigations:

Services:

  • Amino acid analysis
  • Concentration/yield determination
  • Process-related and product-related purity assessment by U/HPLC (Reversed-phase, Size Exclusion, Ion-exchange, etc…)
  • Product purity assessment by capillary (gel) electrophoresis (CE and CGE)
  • Charge heterogeneity and weighted pI determination by capillary isoelectric focusing (cIEF)
  • SDS-PAGE / Western Blot
  • Protein identification by mass spectrometry
  • Cellular potency and in vitro efficacy in cell culture
  • Enzymatic activity assay development
  • Enzyme kinetics studies
  • Glycosylation determination by mass spectrometry
  • Post-translational modification determination by mass spectrometry and CE
  • Host cell protein impurity analysis by ELISA
  • Trace metals analysis by ICP-MS
  • Cell culture media characterization and qualification

    Instruments:

  • Capillary electrophoresis (CE, Protein Simple Maurice)
  • Waters Acquity UPLC with Xevo G2-S Quadrupole Time of Flight (QTOF)
  • Ultra-performance liquid chromatography (UPLC, Agilent) with 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
  • 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

Technical Progress in Therapeutic Enzymes and Proteins

Since the introduction of the first protein therapeutics in the 1980s, this drug modality has steadily grown and diversified, in line with the natural diversity of protein structures and functions. This has been supported by vast improvements in protein and enzyme design, production, purification, and analyses.

One example is the rise of recombinant proteins. These man-made proteins play a pivotal role in antibody therapies, protein replacement therapies (PRTs) and enzyme replacement therapies (ERTs), which remain the gold-standard treatment for a variety of genetic diseases. The first ERT, approved in 1991 for Gaucher disease, was manufactured by isolating the enzyme from the human placenta. Nowadays, ERTs are derived from other human cells, animal cells (i.e. CHO cells), and even plant cells.

To keep pace, bioanalytical testing throughout the development process needs to be dynamic and tailored to both the protein and the manufacturing approach. Given the speed of enzyme and protein therapy R&D, rapidly accessing your biomolecules efficacy and producing an accurate certificate of authentication (COA) are key. Avomeen’s QC-minded team members help you analyze and develop your material to reach those important milestones. With our deep knowledge of protein therapies, we can perform a multitude of state-of-the-art analytics that get you the answers you need, fast.

 

Have questions about how we can help? Contact Avomeen today.

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