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Element’s consultative team of expert scientists work with customers to design molecule-specific analytical strategies for extensive analysis and characterization of proteins and therapeutic enzymes in support of IND and BLA regulatory pathways.

Proteins and enzymes play a critical role in human health and disease, which has led to protein therapeutics playing a central role in modern medicine. Proteins offer a wide range of benefits when compared to small molecule drugs, including more complex mechanisms and the ability to limit off-target effects through specificity. Furthermore, protein therapeutics are often well-tolerated by patients, and can also be used as diagnostic biomarkers. Although orphan disease or fast-track regulatory pathways are available for many investigational protein investigational protein and enzyme therapeutics, there is a constant and growing need for streamlined, cost-efficient protein analytics.

To mitigate common complications and challenges, including protein solubility, stability, distribution, and route of administration, Element’s scientists use a variety of refined protein characterization assays, in conjunction with specialized tools for protein quantification, stability analyses and more. Our consultative scientists have the experience and expertise to help to identify issues unique to peptide and enzyme therapeutics, such as post-translational modifications (PTM) and enzyme kinetics. Element’s comprehensive protein analytics suite of services brings together a wide variety of methods, including amino acid analysis, concentration/yield determination, cellular potency and in vitro cell culture, glycosylation determination, post-translational modification, and more.

Please note while this section focuses on analytical services for proteins and enzymes, information regarding monoclonal antibodies (mAbs) is not included. Due to both their importance and differences compared to other protein classes, Element’s antibody therapeutics offerings are detailed separately; see here for information about monoclonal antibody analytical services.

Comprehensive therapeutic protein and enzyme analysis and support

Leading biopharmaceutical organizations trust Element’s deep bench of scientific expertise to advance therapeutic enzymes throughout the drug development lifecycle, depending upon our highly skilled teams of scientists to develop robust enzymatic activity assays and enzyme kinetics studies. We offer a comprehensive suite of services to support drug substance characterization for IND and BLA regulatory pathways, including analytical method development, forced degradation studies, stage-appropriate method qualification, stability program, impurity identification, and product quality investigations. Furthermore, our strategic method development services enable the optimization of processes, yield, and purity prior to large-scale manufacturing.

Element’s scientists collaborate with customers to determine the best analytical strategy to help them reach their goals, acting as a true partner and extension of their team. Additionally, consultative regulatory experts also provide guidance around the data and documentation needed to demonstrate long-term safety at the preclinical level.

Therapeutic protein analysis and characterization 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
• Analytical method development, validation, and transfer
• Stage-appropriate method qualification
• Biologic product quality investigations
• Contaminant and impurity identification in large molecule therapies
• Protein characterization assays
• Protein quantification
• Forced degradation studies of proteins and enzymes
• Therapeutic protein stability programs

The Element advantage

Element tailors bioanalytical testing to the needs of each specific large-molecule therapy, considering both the protein and manufacturing approach, ensuring the rapid assessment of biomolecule efficacy and swift delivery of an accurate certificate of authentication (COA), keeping you on track to meet critical milestones. Element’s QC-minded scientists help our customers analyze and develop materials to reach those significant milestones. With our deep knowledge of protein therapies, we can perform a multitude of state-of-the-art analytics to provide the answers you need, fast.

For more information about Element’s protein analytics services or to request a quote, contact us today.