Our clients develop safe, efficacious products with confidence thanks to the high quality data we deliver as their partners in Biologics and Advanced Therapy Medicinal Products (ATMPS) such as cell and gene therapy. Element's experience in ATMPS and particularly biological therapeutics span from R&D to CMC activities to support IND and BLA filings, commercialization, and post-marketing product lifecycle management.
What are the key challenges on the path to biologics and ATMPs commercialization?
Biologics and ATMPs 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. Despite this growth, the path to commercialization is bottle-necked by the significant costs associated with Chemistry, Manufacturing, and Control requirements. This is especially true for companies lacking the capacity and know-how in-house to develop and execute necessary analytical methods that meet regulatory intent.
What are the key benefits of Element biologics and ATMP analysis?
When you partner with Element for biologics analysis, you’ll be able to:
- Gain a competitive edge through a more efficient process: As a trusted biopharma contract research organization (CRO) and contract testing laboratory (CTL), Element partners with our customers to increase efficiency, cut down on cost, 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.
- Confidently submit robust data to agencies: Our clients trust that we’ll deliver the critical data they need and answer any questions they have along the way. Along with access to our purposefully equipped labs, you can tap into our team’s expertise in all stages of biologics and ATMP testing, spanning from R&D to commercialization. Our rapid design and development of robust cellular potency or chromatography methods for complex molecules helps clients obtain the pivotal data necessary for regulatory submissions and release testing.
- Receive tailored, phase-appropriate testing services that meet your exact needs: Element’s teams of consultative experts have far-reaching experience working with a wide range of biologic drug products and modalities such as:
- Recombinant proteins
- Recombinant proteins
- Monoclonal antibodies (mAbs)
- Bispecific antibodies
- Antibody-drug conjugates (ADCs)
- Peptides
- Cell and Gene Therapy Products (e.g. adeno-associated virus and lentivirus-associated therapeutics)
- Cancer vaccines
- Microbiome or other bacterially derived products.
Element's industry-leading biologics testing & analysis
Our industry-leading, experienced scientists can develop, optimize, and transfer fit-for-purpose analytical methods for biologics, as well as carry out phase-appropriate method validation and raw material analyses for both mammalian and microbial expression systems.
Recombinant proteins and enzymes: Proteins and enzymes can be active ingredients in replacement therapies or as a reagent in a diagnostic and molecular biology kit. CMC strategies for proteins and enzyme replacement therapies can be incredibly diverse. Element could be your CMC partner while providing you with the analytical solutions for a successful filing.
Monoclonal antibodies represent a large class of biological therapeutics. Common analytical methods to analyze mAbs therapeutics include mass verification by QTOF, purity by HPLC, and assay by immunoreactivity.
Peptides: With properties that land somewhere between small molecules and proteins, peptides have their own analytical challenges. The structure of a polypeptide could be a simple coil-coil, or more complex if they take on a cyclic ring structure, or if they form oligomers and have the tendency to aggregate. Element has the experience to develop and validation robust liquid chromatography methods to analyze peptide assay and related substances. Mass verification by LC-QTOF or immunoreactivity by dot blot are used for identification of peptides.
Gene Therapy & AAV Vectors: Biotechnological advancements in the past few years have gained momentum in regulatory agency made room for safer and more effective gene therapies many of which use adeno-associated viruses (AAV) as viral vectors. However, determining viral vector purity and transduction efficiency remains a significant analytical challenge for many innovators. Here, Element can help companies develop the right method for each unique AAV product using our proteomics experience and extensive mass spectrometry availability, BioRad digital droplet (ddPCR), HPLCs equipt with RI, ELSD, CAD, UV detectors, Protein Simple capillary electrophoresis system, and cell culture facility.
Common Process Impurities Testing: Element has developed analytical methods to detect and quantify common impurities from upstream and downstream biologics manufacturing processes. Common impurities include host cell DNA, host cell protein, Iodixanol, Poloxomer, CsCl, etc. Contact us for the full list of impurities and associated methods.
Biologics test methods & techniques
- Custom designed method development and validation for non-compendial methods utilizing chromatography, mass spectrometry, and bioassays
- HPLC (CAD, IR, ELSD, CD, DAD, FLD, UV Detectors)
- LC-MS/MS (Agilent QQQ, Sciex QQQ, Thermo Orbitrap)
- LC-QTOF
- GC-MS
- GC-MS/MS
- Cell culture
- ddPCR
- Plate readers
- Immunoassays
- Capillary Electrophoresis (CE, CE-SDS by Protein Simple)
- SDS-PAGE
- Western Blot
- Cellular-based potency assays
- Specific activity, enzymatic activity assays
- Peptide map
- Bottom-up proteomics
- Top-down mass determination
- Post-translational modification analysis
The Element advantage
Customers rely on Element’s expertise to ensure the safety, quality, purity, and potency of novel biologics throughout the product development life cycle. 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.
Learn more
Vaccine Analysis
As you develop your vaccines, having assurance that they are safe is a critical regulatory requirement. Element provides vaccine analysis and safety testing.
Gene Therapy
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.
Therapeutic Protein Analysis
Element provides a variety of therapeutic protein analysis and characterization services to design molecule-specific analytical strategies in support of IND and BLA regulatory pathways.
Resources for Biologics Testing Challenges
Getting Ahead of Industry Expectations for Biological Therapeutics Testing
Throughout this article, you'll learn some insight into three different pressures creating changes in industry standards that ultimately impact safety testing in biological therapeutics.
Biologics CMC methods
Click the orange "view methods" button for the complete list of qualified biologics CMC platform methods we offer.