Peptides – With properties that land somewhere between small molecules and proteins, peptides have a long history in human medicine. Our industry-leading, 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. As a trusted biopharma contract research organization (CRO) and contract development and manufacturing organization (CDMO), 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.Įlement’s 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.

Along with access to our purposefully equipped labs, our team has significant expertise in all stages of biologics R&D, enabling the rapid design and development of robust cellular potency or in vitro efficacy methods to help obtain the pivotal data necessary for regulatory submissions and release testing. This is just one of the reasons why Element is an invaluable partner for biologics analysis.

This is especially true for companies lacking the capacity and know-how in-house to develop and execute necessary analytical methods for biologics. Despite this growth, R&D efforts can be limited by the significant costs associated with efficiently discovering biological materials and developing them at a commercial scale. Furthermore, their share continues to increase relative to traditional small molecule drugs. 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.īiologics now represent a major class of modern therapeutics, as the healthcare landscape has undergone a massive shift toward biopharmaceutical drugs over the past few decades.

Biologics development lifecycle