Biologics CROs for Preclinical Programs

2 contract research organizations in our directory list at least one of Antibody Programs, AAV Biodistribution, Oligonucleotide Therapeutics, Cell Therapy, Ligand Binding Assays or Immunotoxicology, across 2 countries. 1 reports GLP capability and 2 report AAALAC accreditation. Compare their species, services and accreditations below, and contact labs directly from their profiles.

2 CROs 1 GLP 2 AAALAC 2 countries

About Biologics

Biologics include monoclonal and bispecific antibodies, antibody-drug conjugates, fusion proteins, peptides, gene therapies, cell therapies and oligonucleotides. Their preclinical programs are shaped by ICH S6(R1), which asks for safety testing in a pharmacologically relevant species: one in which the molecule binds its target and produces the expected effect. For many human-specific antibodies that is only the nonhuman primate, and for some it is no species at all, which means surrogate molecules or genetically modified mice.

Several capabilities separate CROs that handle biologics well. Species selection relies on binding and functional data and, for antibodies, tissue cross-reactivity studies. Bioanalysis uses ligand binding assays for PK and anti-drug antibody (ADA) assays for immunogenicity, which can change exposure in repeat-dose studies. Gene and cell therapies add biodistribution, shedding and persistence endpoints, and oligonucleotides bring class-specific findings and often require CNS delivery routes.

If you are asking which CROs offer in vivo pharmacology for antibody programs, start with the antibody programs list below and confirm two things with each lab: that its models express a target your antibody binds, and that it can measure both drug levels and ADA in the same animals.

Species selection guide →

Showing 2 CROs. Order rotates daily so no lab is permanently listed first.

NeuroBridge

CN Verified GLP AAALAC

NeuroBridge Biotechnology is a specialized preclinical research organization based in Guangzhou, China, focused on non-human primate (NHP) and pig disease models and exploratory non-GLP translational studies. We support…

AAV Biodistribution Oligonucleotide Therapeutics Acute Toxicity ADME Studies Behavioral Assessment Cynomolgus monkey Minipig Non-human Primate Rhesus monkey

Biomere

US Verified AAALAC

Biomere (a JOINN company) is a preclinical CRO based in Worcester, MA. Services include non-GLP PK/PD, discovery toxicology, surgical services, disease models, and laboratory sciences. Surgical services include…

AAV Biodistribution Oligonucleotide Therapeutics Bioanalysis Bioavailability Studies Biodistribution Cynomolgus monkey Minipig Mouse Non-human Primate

Questions to ask when choosing a Biologics CRO

  • Which species do you consider pharmacologically relevant for our molecule, and what data support that?
  • How many biologics programs of our modality have you taken through IND-enabling studies?
  • Do you run PK, ADA and neutralizing antibody assays in-house, and to what validation standard?
  • What is your current lead time for cynomolgus monkey studies?
  • For gene and cell therapies, how do you measure biodistribution, shedding and persistence?