Therapeutic Enzymes & Protein Analysis
Accelerate your protein therapeutic development with comprehensive analytical support tailored to your specific molecules. Our consultative scientists deliver specialized characterization, stability analysis, and testing data that supports your IND and BLA submissions. We provide swift, accurate results with a QC-minded approach, helping you overcome development challenges throughout your product lifecycle.
What is Therapeutic Enzymes & Protein Analysis at Element?
Therapeutic protein analysis provides comprehensive characterization and testing of protein-based drugs to validate their safety, efficacy, and quality for medical use. At Element, our team of expert scientists works with you to design molecule-specific analytical strategies for extensive analysis and characterization of proteins and therapeutic enzymes in support of IND and BLA regulatory pathways.
What Can Element Offer You For Therapeutic Enzymes & Protein Analysis?
What we test
What we test
Support your development pipeline with comprehensive analysis of therapeutic proteins and enzymes. Our testing covers process-related and product-related impurities, host cell proteins, trace metals, and cell culture media. We analyze post-translational modifications, glycosylation patterns, and protein structure to provide complete characterization of your therapeutics.
Key tests offered
Key tests offered
- Amino acid analysis and concentration determination
- Process-related and product-related purity assessment
- Protein identification by mass spectrometry
- Cellular potency and in vitro efficacy testing
- Enzymatic activity assays and kinetics studies
- Glycosylation and post-translational modification analysis
- Host cell protein impurity analysis
- Trace metals analysis by ICP-MS
Methods and solutions offered
Methods and solutions offered
Element's comprehensive protein analytics suite brings together a wide variety of methods to support your development from early-stage characterization through regulatory submission and manufacturing scale-up. Our services include amino acid analysis, concentration/yield determination, cellular potency and in vitro cell culture, glycosylation determination, and post-translational modification. 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
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.
Which labs offer this service
Which labs offer this service
Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.
Regulatory-aligned testing
Regulatory-aligned testing
Navigate complex regulatory requirements with our comprehensive testing approach. Our scientific experts help design analytical testing strategies that generate the data you need for IND and BLA submissions. We focus on delivering high-quality analytical results that support your regulatory journey from development through approval.
Materials we test
- Therapeutic proteins
- Therapeutic enzymes
- Cell culture media
- Process-related impurities
- Product-related impurities
- Host cell proteins
- Post-translational modifications
- Glycosylation patterns
Your Challenges, Our Solutions
Streamlined regulatory compliance
Optimized protein stability
Efficient manufacturing scale-up
Smart analytics solutions
Why Choose Element
True partnership
Comprehensive analytics
Speed to market
Quality-focused approach
Explore our global network of labs and find your nearest location
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