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.
Element’s comprehensive protein analytics suite of services brings together a variety of methods, including amino acid analysis, concentration/yield determination, cellular potency and in vitro cell culture, glycosylation determination, post-translational modification, and more.
Leading biopharmaceutical organizations trust Element’s deep bench of scientific expertise to advance therapeutic enzymes throughout the drug development lifecycle, depending on our Ph.D.-led teams of scientists to develop robust enzymatic activity assays and enzyme kinetics studies.
Therapeutic protein analysis and characterization services
- Analytical method development, validation and transfer
- Biologic product quality investigations
- Contaminant and impurity identification in large molecule therapies
- Forced degradation studies of proteins and enzymes
- Protein characterization assays
- Protein quantification
- Stage-appropriate method qualification
- 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.
For more information about Element’s protein analytics services or to request a quote, contact us today.
Nearly 190 Years of Making Certain
More from Element
As you develop your vaccines, having assurance that they are safe is a critical regulatory requirement. Element provides vaccine analysis and safety testing.
Element uses a wide range of orthogonal analytical methods and capabilities to ensure the safety, identity, quality, purity and strength of gene therapies.
Monoclonal Antibody (mAb) Characterization & Analysis
Element’s phase-appropriate monoclonal antibody (mAb) characterization and analytics services are tailor-made to meet your needs throughout the biopharmaceutical product lifecycle.
Element’s comprehensive bioanalytical testing services are dedicated to bringing industry-leading scientific expertise to help customers advance drug development programs.