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 Team
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.
This is just one of the reasons why Element is an invaluable partner for biologics analysis. 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. 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.
Element’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. 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.
Biologics Analysis
Peptides – With properties that land somewhere between small molecules and proteins, peptides have a long history in human medicine. They also have their own bioanalytical challenges, particularly bioavailability and peptide stability. Element understands the unique challenges associated with determining peptide purity and potency and can help you investigate your molecules stability through forced degradation studies.
Proteins and enzymes – Proteins and enzymes can be used for an incredibly diverse set of therapeutic functions, from replacement therapies to diagnostics. Element offers standard analytical services such as extra characterization, forced degradation studies, peptide map analysis, product-related and process-related purity analyses, specific activity, in vitro cellular uptake method development and validation, and more.
Monoclonal antibodies (mAbs) – Monoclonal antibodies represent the fastest growing class of protein therapeutics. Given their clinical (and economic) significance, Element has devoted special resources and techniques to mAb bioanalytical testing.
Gene Therapy & AAV Vectors – Biotechnological advancements in the past two decades have 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 Protein Simple capillary electrophoresis system, UPLC capabilities, and cell culture facility; all while keeping clinical safety at the forefront.
Biosimilars – As biopharmaceutics continue to grow in emphasis and importance, an increasing number of FDA-approved innovator biologics’ patents will expire. As a result, biosimilar development will expand significantly. While these materials can reach the market rapidly, there are challenges associated with proving the similarity of these new product to the originally approved innovator drug. Element understands the emerging potential biosimilar development holds and knows how to efficiently compare biologics to determine similarity.
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
- • SDS-PAGE
- • 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 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.