It has been a year since Sigma-Aldrich acquired testing specialist BioReliance. Its new logo, ‘BioReliance by SAFC’, was chosen to avoid losing customer recognition, while allowing SAFC to establish an identity and relationship with the business. Here, BioReliance President, Charlie Harwood offers a glimpse into the company’s history and activities – and what sets it apart from the competition.
BioReliance’s history dates all the way back to 1947, and its latest incarnation as part of Sigma-Aldrich follows a number of ownership changes – and name changes – over the years. During those 65 years, it has been involved in a diverse range of activities, including the commercial supply of cell cultures, creating the first biosafety protocol for polio vaccines, and even the development of safety testing for the first rocks brought back from the moon! But at its core, the company’s expertise has always been the safety testing of products made via biomanufacturing processes, and it has a strong reputation as an innovator in toxicology and the testing of biologics.
So what does the business offer customers now? About 80% of its revenue derives from the testing of biological (“large molecule”) products. This is an essential part of the manufacture of biologics – strict monitoring of the entire process is essential to avoid the possibility of contamination from the original raw materials, viruses or microorganisms that are part of the production process. This testing is so important because many of these products are for human use and, in contrast to small molecule drugs made by chemical synthesis, there are inevitably variations between batches in biomanufacturing processes. Additionally, biological processes used to manufacture large molecules can be contaminated by human pathogens. Regulatory authorities require that all risk be assessed and mitigated effectively before a product can be brought to market.
A range of specifications must be met throughout the entire research, development and manufacturing process for a biopharmaceutical, with additional requirements for each batch of product before it is released to patients. BioReliance supports testing at every stage, from early research to final product, in many cases offering one-time testing of the molecules used, or to characterize a specific cell line. Final product batch tests ensure they meet the stringent regulatory requirements, both in terms of purity and activity.
In addition to these activities, the remaining 20% of the business’s activities involve project work on small molecule product testing, animal specimen testing, and the most recent addition to the portfolio – genomic testing for clinical specimens.
Over the years, BioReliance has developed a great reputation for specialized testing in the industry. This has been achieved thanks to expert staff that develops custom solutions for each customer. They also remain dedicated to learning the ins and outs of scientific developments and industry regulations – keeping up-to-date is vital!
Perhaps the most exciting part of the business is the development of new assays, whether molecular or otherwise, that allow tests that have never been done before to be carried out. As well as working with the newest in vitro tests, the ability to troubleshoot any positive findings right down to the point of origin is key. The ramifications of these positives are huge – they can put a critical, life-saving product on hold, or cause the shutdown of a whole biomanufacturing process or, in the worst cases, even entire facilities.
The hope in all safety tests is that there will be no positives and thus no evidence of contamination. But when positives do occur, the source must be pinpointed – whether it is the reactor, the lab, a one-off contamination, or even a flaw in the process itself. Being able to identify the root of the contamination as quickly and effectively as possible is one of our most important skills. While our testing process is only a small part of the pharmaceutical value chain, it is of key importance to the security of the product – and the safety of patients.
We are proud of what we do, our customer service, and the fast turnaround times we offer our customers. In our first year as part of Sigma-Aldrich, we have worked hard to educate SAFC sales staff about what we do. While there may be more focus on integration in the future, the immediate aim is to maximize exposure and knowledge transfer between the two companies so we can continue to develop, and meet our customers’ needs, both now and in the future.
To learn more about BioReliance by SAFC, please visit www.bioreliance.com
To learn more about SAFC, please visit www.safcglobal.com