Element’s significant expertise in all stages of biologics R&D, from in-house protein biochemistry and molecular biology to cellular biology and QC experience, supports the entire product development life cycle from early discovery through IND, BLA, and beyond.
Element’s Ph.D.-led teams of consultative experts have far-reaching experience working with a wide range of biologic drug products and modalities including proteins, peptides, monoclonal antibodies (mAbs), bispecific antibodies, antibody-drug conjugates (ADCs), adeno-associated virus and lentivirus-associated gene therapies, cell therapies, cancer vaccines, and microbiome or other bacterially derived products.
As a trusted biopharma contract research organization (CRO), Element partners with our customers to accelerate R&D efficiency and break down barriers, ensuring customers have the crucial data needed each step of the way during drug development, from discovery to regulatory submissions and beyond.
Element’s industry-leading team of experienced scientists can develop, optimize, and transfer fit-for-purpose analytical methods for biologics and biosimilars, as well as carry out phase-appropriate method validation and raw material analyses for both mammalian and microbial expression systems.
Biopharmaceutical & biologics test methods & techniques
- Amino acid analysis
- Assessment of purity, including AAV purity
- Cell culture media validation
- Cell-based bioassay services
- Cellular potency/efficacy and toxicity
- Determination of concentration/yield
- Determination of viral particle titer
- Forced degradation studies
- Glycosylation determination
- Impurities testing (process and host cell protein impurities, trace metals)
- Method development (specific activity, enzyme kinetics, PK/PD)
- Peptide mapping
- Post-translational modification determination
- Protein characterization
- Raw materials and standards qualification
- Transduction efficacy
- Western Blot
The Element advantage
Customers rely on Element’s comprehensive biologics and biopharmaceutical bioanalysis, analysis, and characterization services to ensure the safety, quality, purity, and potency of novel biologics and biosimilars throughout the product development lifecycle. Our team of experienced scientists stay up to date with the latest scientific breakthroughs and regulatory guidance, ensuring that your large molecule development and manufacturing programs meet rigorous safety, quality, and efficacy standards.
For more information about Element’s biologics analysis or to request a quote, contact us today.
Nearly 190 Years of Making Certain
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