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Biologics testing
Biologics testing
Mavens offers a one-stop-shop for biologics/biosimilar testing, including toxicology, TK, and immunogenicity evaluation. For toxicological research, Mavens has assessed over a dozen biologics/biosimilars.
The following Biologics/Biosimilar services are provided by Mavens.
Toxicology services for Biosimilars:
Toxicology studies (GLP)
- Single-dose Toxicity study in most relevant species (mice/rats/dogs)
- Repeat Dose Toxicity study with Recovery & Immunogenicity (mice/rats/dogs)
- Local Tolerance Study in rabbits
Toxicology Services for Biologics:
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 / Large Molecule Analysis:
Biologics are sophisticated living-system products that are being used in a variety of therapies. Their analysis is more difficult and time-consuming than that of tiny molecules. These biologics can trigger severe allergic and anaphylactic reactions, as well as immunological responses that can reduce their efficiency. For all of your biologics analysis needs, Mavens has extensive expertise in designing and validating sensitive and specific analytical/immunogenicity procedures. The procedures are tailored to the specific needs of your biologic product, such as peptides, enzymes, monoclonal antibodies, vaccines, and gene therapy products.
Our team has worked on a variety of biologics services, including end-to-end development, validation, and sample analysis; method transfer and validation; commercial kit optimization and sample analysis, and so on.
- In-house production of particular essential reagents (polyclonal antibody).
- Pharmacokinetic parameters are assessed using precise and sensitive procedures that have been validated according to the most recent criteria.
- A multi-tiered method was used to determine immunogenicity.
- Anti-drug-antibody (ADA) screening assay
- Confirmatory assay
- Titre estimation
- Neutralizing antibody assay by ELISA or cell-based assays
- Antibody isotyping
- Functional bioassays
- Biomarker analysis such as Cytokines
- Well-defined strategies for specific assays.