Biologics / Vaccines / Biosimilars

Biologics are a class of drugs and medicines that have genes or proteins as their therapeutic targets. They are large, complex molecules, comprised of biological products such as microorganisms and living cells, and are produced in such systems. Adgyl Lifesciences conducts the full range of Good Laboratory Practice (GLP) and Non-GLP Safety/ Toxicology studies for the development of Biologics within its AAALAC-accredited animal facility. In addition, Eurofins Advinus is a specialist in the preclinical and clinical analysis of Biologics. The Test facility has more than 20- years of experience in conducting Biologics studies for Novel biologics, Biosimilar monoclonal antibodies & Fc fusion proteins, ADCs, Peptides, Vaccines and Gene therapy products, using WHO protocols in various animal models: Rodent, Rabbit, Minipig and Canine, striving to advance scientific knowledge and contribute to the betterment of public health.

Our Expertise:

Toxicokinetic & Immunogenicity studies: As a service provider, we recognize the essential role of toxicokinetic and immunogenicity studies in biologics’ preclinical and clinical development, encompassing monoclonal antibodies, gene therapies, vaccines, and therapeutic proteins. These evaluations assess safety, efficacy, and potential risks linked to human administration.

In Toxicokinetic Studies, our expertise includes investigating biologic behavior within the body, encompassing absorption, distribution, metabolism, and excretion. This extends to analyzing potential interactions with toxins or drugs, determining dosages, dosing regimens, bioavailability, distribution, metabolism, excretion, pharmacokinetic parameters, and toxicity assessment.

In Immunogenicity Studies, we delve into a biologic’s ability to trigger an immune response, particularly in antibody development. This includes detecting anti-drug antibodies, identifying neutralizing antibodies, evaluating clinical impact, cross-reactivity, and assessing potential risks posed by the immune response.

Our comprehensive studies begin in preclinical animal models and extend into clinical trials, informing dose strategies, patient monitoring, and risk management. Notably, regulatory agencies like the FDA and EMA mandate robust toxicokinetic and immunogenicity evaluations for regulatory submissions, ensuring patient safety and advancing biologic drug success.

Vaccine safety studies:  Our specialized expertise extends to both known and exploratory adjuvants, encompassing absorption, distribution, metabolism, and excretion. With a focus on both established and innovative adjuvants, our comprehensive approach ensures a deep understanding of vaccine safety, guiding the development of effective and secure vaccination strategies.

Regulatory Compliance: QAU inspects the critical phases of all studies and with a track record of more than 20,000 completed GLP studies, our testing facility has established a proven reputation for generating top-tier research that aligns with the criteria of diverse regulatory agencies.

Type of our studies:
  • Genotoxicity (GLP) For Novel vaccine adjuvants and additives
    • Ames Test
    • In vitro chromosomal aberration test in Human Peripheral Blood Lymphocytes (MUT-CHAB/HPBL)
    • Micronucleus test (MNT) in mice/rats
  • Safety Pharmacology (GLP)
    • hERG assay
    • Pulmonary functions (rats)
    • Modified Irwin Test/Functional Observation Battery in rats (FOB-rats)
    • CVS function assessment using telemetered dogs
  • Toxicology studies (GLP)
    • Single dose Toxicity study in most relevant species (mice/rats/dogs)
    • Repeat Dose Toxicity study with Recovery & Immunogenicity (mice/rats/dogs)
    • Carcinogenicity Studies in rats or mice or Transgenic mice?For Novel vaccine adjuvants and additives
    • Local Tolerance Study in rabbits
    • Juvenile toxicity studies in rodents
    • Humoral or Cell Mediated Immune (CMI) Response Assessment
  • Reproduction studies (GLP)
    • Fertility and early embryonic development to implantation (SEG-I)
    • Prenatal developmental study (SEG-II)
    • Peri-natal and post-natal developmental study (SEG-III)
Biologics Bioanalysis Services for Novel biologics, Biosimilar monoclonal antibodies & Fc fusion proteins, Peptides, Oligonucleotides, Vaccines and Gene therapy products
  • Regulated bioanalysis (PK/TK) as per ICH M10 guideline under GLP
  • Immunogenicity (Tiered ADA & NAb) as per US-FDA guideline under GLP
  • Biomarkers
  • Serological assays for vaccines & gene therapy products (Antigen and capsid specific titer)
  • Cell based potency assays.
Experience in Customized Polyclonal Antibody Generation for Biologics like antibodies and peptides
  • Applications
    • Positive control for immunogenicity assay
    • Capture and/or detection reagent for PK/TK assay
  • Purification
    • Protein A/G/L
    • Antigen specific
  • Labelling
    • HRP, AP, Biotin, Digoxigenin
  • Identity and Purity
  • Drug-to-Antibody Ratio (DAR)
  • Potency and Cytotoxicity
  • Heterogeneity and Aggregation
  • Residual Impurities
  • Endotoxin
In Vitro Immunogenicity Assays for Evaluating Generic Peptide Drug Products
  • The number of abbreviated new drug application (ANDA) submissions for peptide products has been growing in recent years.
  • The FDA’s draft guidance on ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin (October 2017) provides recommendations for demonstrating equivalence of generic peptide products to their respective reference listed drugs (RLDs).
  • Using in vitro methods to evaluate sameness of impurity profiles and associated immunogenicity risk between the generic and RLD peptide products is recommended in this guidance.

Partner with us for cutting-edge studies in Biologics, Vaccines, and Biosimilars, which adhere to the highest standards of quality and compliance.