Dr. C Tamilselvan

Managing Director

Increasing awareness has led to the development of more comprehensive regulatory frameworks, which, in turn, enhance the overall safety of the food supply. Microbiology testing services ensure that products developed, manufactured, and marketed are safe, effective, and compliant with stringent regulatory requirements. As the industry grows, the demand for reliable, accurate, and timely microbiology testing has surged, making it a critical focus for organizations globally. In India, the microbiology testing services market is poised for significant growth, with an annual increase of around 5 percent. This growth is driven by rising consumer awareness about food safety, stricter regulations, and the increasing complexity of pharmaceutical production and research. As consumer awareness grows, so does vigilance regarding food safety, prompting all stakeholders—regulators, manufacturers, and governments—to prioritize food safety.

However, there have been instances where Indian products, particularly in the pharmaceutical and food sectors, have faced lapses in safety standards, leading to concerns when these products are exported. The positive side is that this situation has spurred swift regulatory action. For example, Good Manufacturing Practices (GMP) are now enforced more rigorously in the pharmaceutical sector. Additionally, the Indian government has introduced various schemes to help laboratories enhance their facilities and capabilities. Indian laboratories, including Bioscience Research Foundation (BRF), are well-equipped to meet these challenges. BRF, in particular, offers a comprehensive suite of microbiology services tailored to pharmaceutical, agrochemical, and food safety needs. It boasts specialized facilities, such as a radioisotope testing laboratory to monitor residual effects in gamma-irradiated food, ensuring high levels of safety and compliance.

“We have a comprehensive range of facilities that meet the needs of pharmaceutical companies and manufacturers, not just for Indian regulatory standards but also for global norms, including those from the US, EU, China, Australia, and South American markets,” says Dr. C. Tamilselvan, Managing Director at BRF. “We possess all the necessary capabilities to address their regulatory needs. Clients can come to us for everything from basic microbial identification to advanced sequencing.” The company can handle routine bacteria as well as more complex virus studies. Notably, it is one of the few labs equipped to conduct virus inactivation studies for medical device clients, helping them meet critical requirements for regulatory agencies such as the US FDA.

Navigating the Global Surge

The global medical device industry is rapidly expanding, driven by heightened regulatory demands and government efforts to improve quality and supply chain resilience, leading to bottlenecks in testing capabilities as laboratories struggle to meet increasing compliance requirements. BRF has responded to this challenge by making significant investments in the medical device sector over the past few years. The company offers a comprehensive medical device testing service, including biocompatibility and virus inactivation studies as well as functional testing. Recently, it introduced implantation services, a critical yet rare capability among labs, covering everything from small animal models to larger ones like canines, swines, and mini pigs. To support this, it has developed state-of-the-art surgical suites equipped to handle complex surgeries with veterinary surgeons.

Moreover, BRF has heavily invested in Extractables and Leachable (E&L) testing, recognizing the growing awareness and importance of these analyses. The lab is equipped with advanced mass spectrometers, HRMS, GC-MS triple quads, LC-MS triple quads, and all necessary chromatography and NMR equipment. Its facilities also cover preclinical studies, including PK/PD, ensuring it can handle every aspect of medical device testing. With enhanced throughput, the company offers faster turnaround times, helping clients expedite their regulatory approval processes. It works closely with manufacturers, providing support throughout the regulatory journey, from initial testing to addressing any queries that arise during the approval process, ensuring clients can bring products to market efficiently and successfully.

BRF also plays a critical role in supporting pharmaceutical companies and drug discovery efforts through its comprehensive, end-to-end services. Recently, the company inaugurated a state-of-the-art large animal facility, addressing one of the key bottlenecks in preclinical research—the availability of quality canine and mini pig models for testing new pharmaceutical drugs. This capability, rare in India and often accompanied by long waiting lists at other labs, enables the company to significantly reduce backlog and accelerate the timelines for its clients, helping Indian pharmaceutical companies bring their products to market more quickly and move into clinical investigation phases sooner.

In addition, BRF offers radioisotope services crucial for understanding drug metabolism, as well as advanced imaging services, essential for assessing drug safety and tracking where compounds accumulate within preclinical models. These capabilities are especially valuable for clients developing novel or emerging therapeutic products, including those working with nanotechnology, a growing area of interest in the industry. Its extensive experience in handling nano products further underscores its ability to meet the complex and evolving needs of its pharmaceutical and drug discovery clients.

Strengthening Standards

Unlike others, BRF provides a truly end-to-end solution within a single, unified facility. Spanning over 1.5 lakh square feet, the lab houses more than 500+ state-of-the-art instruments, multiple clean rooms, and a team of around 300+ highly trained professionals, all well-versed in regulatory aspects and GLP standards. The centralized approach allows the company to cover everything from basic physical and chemical analysis to complex studies like radiology, pathology, biochemistry, toxicology, genotoxicology, and pharmacology—all within the same facility.

The comprehensive range of services offered ensures that manufacturers can rely on the facility to manage every aspect of their testing needs, maintaining consistency and quality control throughout the process. Having generated over 15,000 GLP reports for more than 300 clients worldwide, the facility has established a strong reputation for reliability. These reports, recognized and accepted by regulatory agencies globally, enhance confidence in the product's ability to pass scrutiny without significant issues. In the event of regulatory questions, the facility provides extensive support, including 10 years of archival services by GLP norms, ensuring that manufacturers can return for assistance at any time.

Chemistry forms the backbone of any preclinical CRO and BRF's chemistry department stands as one of the largest in the company, with over 50 experts and an impressive array of advanced equipment, including more than 40 HPLCs, multiple top-of-the-line LC-MS, HRMS, GCMS, and NMR systems. The extensive suite of chemistry services supports standalone projects and other departments, particularly as regulatory norms, including GLP, demand rigorous chemistry data for everything from dosing animal models to conducting field studies on agrochemicals. As biosimilars and bioanalytical services become increasingly crucial, the company remains one of the few labs in India offering comprehensive GLP-compliant chemistry services, bolstered by a highly qualified team and cutting-edge instruments, ensuring clients receive timely, accurate reports. Recognizing a critical bottleneck in the availability of quality reference standards, BRF is planning a state-of-the-art facility dedicated to synthetic chemistry services. While this facility is in development, the company is already addressing client needs through in-house preparatory HPLCs, flash chromatography, and other purification equipment, ensuring that testing timelines and costs are effectively managed.

By investing in the latest technology and staying at the forefront of innovation, the company can offer its clients cutting-edge solutions that meet their needs in a timely and cost-effective manner. For example, it has been one of the leaders in adopting rapid microbiological methods (RMMs), which offer faster results without compromising accuracy. These methods are particularly valuable in today’s fast-paced industry, where time is often of the essence.

The facility is committed to continuous investment and innovation, driven by an unwavering dedication to upgrading and expanding its capabilities. The emphasis is on acquiring the most advanced equipment and ensuring that every aspect of the facility remains state-of-the-art. This commitment extends to providing top-tier training for scientists, recognizing that the combination of cutting-edge technology and expert training is essential for achieving optimal outcomes. Trust is paramount in the industry, as manufacturers entrust the facility with their products, often before they reach the market. The facility has significantly expanded its footprint in just eight years since obtaining GLP certification, tripling its size. Plans are underway to further increase laboratory space by 50-60 percent in the coming year, adding 70,000-80,000 square feet. Alongside this expansion, staff numbers are expected to grow by 30-40 percent, ensuring that the facility can continue to meet the evolving needs of its clients with the highest standards of quality and reliability.