Q&A Part 2: The Best of Antibody Manufacturing

Rockland Immunochemicals, Inc. controls all aspects of the antibody production process. This means that we can carefully manage each step when developing and producing an antibody and select the desired quality and performance characteristics of all the antibodies we produce. Primary antibodies like ZO-1, for celiac disease research, or anti-GFP, for neuroscience research, can be selected for the performance characteristics most highly desired by researchers for these targets. Antibodies are screened by various quality control assays at multiple points of the manufacturing process.

We conduct quality control (QC) testing in primary model systems to ensure biological accuracy in an ISO 9001 certified facility.

The key to quality in manufacturing is to be able to reproducibly produce optimized material batch after batch. To do that successfully you should be able to measure and characterize the materials at all critical steps in the manufacturing process. We have stringent metrics at each of the many stages of our manufacturing process that allow us to ensure only high-quality materials pass from one stage to the next. Under our ISO13485 system we are continuously looking for improved processes that let us raise the bar on these metrics. After many years of manufacturing at high volumes, we have been able to incorporate a large number of process improvements which, in combination, have resulted in a very efficient process that yields exceptionally predictable antibodies and antibody conjugates.

The quality of our products is embedded in the scientific culture of Cell Signaling Technology (CST). Founded 20 years ago by research scientists, we’ve maintained our dedication to quality over quantity. We understand how critical our reagents are to the success or failure of an experiment. Ph.D.-level scientists select the targets, determine biological models, design the antigens, develop the testing strategies, refine and evaluate the results, create the protocols, confirm lot-to-lot consistency, and provide technical support across all applications. Our pride is measured not by adherence to budgets or timelines, but by the number of publications that use our products, by the number of manuscripts published from in-house research, and by seeing our own discoveries lead to beneficial diagnostic and therapeutic outcomes. Therefore, our products are gated by our commitment to ensure the release of quality, consistent antibodies.

We are proud of our comprehensive manufacturing process, which starts with antigen development and immunization and finishes with routine quality assurance testing. For new targets we design multiple immunogens, taking into consideration any post-translational modifications, structure, cross-reactivity, and species homology. In most cases we discuss target selection with leaders in key research areas and utilize their expertise to guide development and validation. This is followed by a multi-step, multi-application validation process. A very important step in this process is the technical review carried out by an independent team of scientists who critically examine each piece of data and only those antibodies that pass this stringent review are made available to our customers.

We are particularly proud of our REAfinity™ Recombinant Antibody portfolio. With more than 1,000 clones and more than 10,000 fluorochrome-conjugated antibodies, we offer by far the largest recombinant antibody portfolio for flow cytometry applications.