Assay Antibodies

ASSAY Antibodies for ADA, PK/PD studies

Pharmaceutical and Biopharmaceutical companies place great trust in Cambridge Research Biochemicals (CRB) to design and produce their ADA (Anti-Drug) antibodies for Immunoassays and Immunogenicity safety studies at the pre-clinical stage of their Biotherapeutics (often a Mab IgG, Bi-specific antibody or Fab fragment).

We believe the key ingredients for producing a successful set of Immunoassay antibody reagents are:

  • Understanding – time is taken at the onset of the enquiry to understand timelines, goals and quantities required by the Biopharmaceutical company and their partner Bioanalytical (CRO) testing facility to ensure realistic deliveries are met and enough material is supplied without having to repeat an already lengthy process of generating antibodies
  • Assay Antibody Quality –  the highest quality animals are used for generating high-response antibodies with clean/low backgrounds and this is due to using highly reliable, regulated and clean animal house facilities in the UK (Home Office approved) and USA (USDA approved), collaborators we trust that have strict measures in place to ensure the well-being and holistic care of their laboratory animals
  • Reliable and optimum supply – we advise on the number of animals to generate the volumes of antisera and purified antibody required to fulfill all testing and have a plethora of experience to guide on optimised immunisation protocols; option to extend schedules for higher affinity and to bank sera; screening and purification strategies for the best yield attainable thereby delivering one final batch of antibody
  • Project management – CRB have been designing and generating antibodies since 1985 and therefore are adept at keeping customers regularly updated with progress and decision points along the way to ensure delivery expectations are met. An online Antibody portal is kept updated with scheduling, ELISA results and Affinity purification data as well as systematic emails and pre-arranged Video/teleconferences from the Immunology team
  • Storage of antibodies and data – we offer short or long-term storage at 20oC and -80ofor polyclonal antibodies and cryogenic preservation (liquid nitrogen) for Monoclonal antibodies (cell-lines, clones, supernatants). All project data is stored on our Claris FileMaker bespoke database as well as our Antibody portal and backed up every day so that projects can be returned to in years to come.

We produce Polyclonal antibodies against the target drug in high yield at high affinity and can increase the specificity by depleting against human IgG (or cyno IgG).

For Pharmacokinetics (PK/PD) and Pharmacodynamics studies, Monoclonal antibodies are the antibody of choice and can be tuned (by screening techniques) to provide anti-idiotypic and neutralising antibodies. We expand and sub-clone to deliver a diverse range of clones to provide neutralising and non-neutralising; mutant vs wild-type and PTM site-specific vs unmodified.

We are here to support you with these critical assay reagents and are readily available for open discussion about our techniques, planning and design.