: What are the most important factors that a manufacturer should focus on when making an antibody?
CC: Antibody specificity to the desired protein or epitope in the stated application, testing in relevant positive and/or negative cells including primary models, application of the antibody in different immunoassays, and lot-to-lot consistency in performance.
: What aspect of your manufacturing process are you most proud of?
CC: We conduct quality control (QC) testing in primary model systems to ensure biological accuracy in an ISO 9001 certified facility.
: How does your company ensure the quality of the antibodies it produces?
CC: BD carefully selects and characterizes antibody content in product development and tests in relevant primary model systems to ensure biological accuracy.
: How do you ensure lot-to-lot consistency with your products?
CC: BD conducts rigorous QC testing of each antibody lot tested side-by-side with a previously produced lot as reference.
: What is your process for validating a given antibody for a specific application?
CC: Our product development process includes testing on a combination of primary cells, cell lines and/or transfectant cell models with relevant controls using multiple immunoassays to ensure biological accuracy. We also perform multiplexing with additional antibodies to interrogate antibody staining in multiple cell populations.
: How does your company view the issue of antibody validation? Who is ultimately responsible for ensuring that scientific results are reproducible?
CC: BD believes antibody validation is critical to ensure accurate scientific results. Both the consumer and the reagent provider share the responsibility for reproducible science.
: How do you incorporate customer feedback into your processes?
CC: In early stages, customer feedback is crucial to determining what antibodies we develop. During development, we utilize customer feedback in beta testing to review our development data and to test pre-market antibodies for biological accuracy in different applications. Post-market, we gather customer feedback via sales and customer service teams, which provides important information about our product performance.