Crystal Biological Solutions: Revolutionizing Drug Development In Preclinical Research & Biocompatibility Testing

Dr. Yogesh Talekar, Technical Director

Dr. Yogesh Talekar

Technical Director

In the dynamic realm of pharmaceutical breakthroughs, where the quest to deliver transformative therapies to patients is ceaseless, a new leader is reshaping the landscape of drug development. Based in Pune, Maharash­tra, Crystal Biological Solutions (CBS) is emerging as a prominent preclinical contract research organization and a pioneer in laboratory animal breeding. CBS is dedicated to becoming a reputable biocompatibility testing lab with unwavering operational excellence, competence, and im­partiality. Their commitment lies in furnishing top-tier test reports aligned with regulatory guidelines. CBS's peculiari­ties are swift, amiable, efficient customer support along with rapid project completion.

The driving force behind CBS is the visionary duo of Dr. Yogesh Talekar and Nitin More. Dr. Yogesh holds a Ph.D. in pharmacology and toxicology from Maharashtra University of Health Sciences and takes the reins as the Technical Director and Study Director. His journey spans a decade, crafting him into an industry stalwart. The second luminary, Nitin More boasts a background in chemical engineering and guides organizational management with precision. Nitin also a test facility manager leverages his five-year immersion in testing to steer scientific pursuits. Hailing from remote areas, they exemplify the spirit of first-generation entrepreneurs fueled by a relentless passion for leaving a lasting imprint in the domains of science and business.

"We initiated CBS in 2018 with the support of our prior sesame oil venture, under the Swarajya India group. Our journey began with animal breeding and expanded into research services. Upon receiving positive feedback, we earned acceptance from IAS, the International Accreditation Service of the United States. With over 17 countries hailing from Germany, Japan, Thialand and various European nations, our focus remains primarily on medical devices. I think it's great that we're getting over 150 tests for regulatory purposes and 132 test substances for research in our initial years”, highlights Dr. Yogesh.

Cutting-edge Facilities & Services

CBS services encompass regulatory toxicology testing and preclinical research, adhering to industry standards Services as per Regulatory Guidelines ISO 10993, OECD, FDA, ASTM, and USP. The organization supplies quality laboratory animals like rats, Mice, rabbits, Guinea pigs, and Hamsters within a hygienically well-maintained breeding facility. Equipped with state-of-the-art scientific instruments, CBS caters to various industries such as pharmacology, biocompatibility/biological reactivity, and pesticide. This wide-ranging industrial clientele includes pharmaceutical, bio-pharmaceutical, medical device, agrochemical, herbal, nutraceutical, food, Packaging and FMCG companies. Organization offers in vitro testing facility and an in vivo testing facility along with genotoxicity.

Dr. Yogesh elaborates, “Our clientele consists of two categories industrial clients and PhD students, the latter finding a platform for preclinical studies. For instance, students are working on transforming Ayurvedic treatments into modern science, like anti-cancer, PCOS, Cardioprotective and many more. They take plant extracts, study the chemical structures, and do synthesis, and we carry out such research for them for their university projects. In any study, there are two parts: in vitro is the part in which we can carry out research outside the body; it is mainly cell line/tissue culture; and in vivo, research undergoes inside the body, in laboratory animals such as mice and rats. Further, we induce disease in animals and treat them as per the protocol to ensure safety and efficacy. The selection of experimental animals is according to the type of research. Further, in safety testing and toxicology, many industries in the market reach out to develop products. For any new developments, one has to get regulatory approval. like in the pesticide industry, where we carry out tests as per OECD guidelines and submit the reports to our client.”

CBS's cornerstone lies in consistent operations driven by competence & impartiality

Dr. Yogesh Talekar, Technical Director

A Research Council for Client

CBS operates with a pronounced focus on medical devices, extending its reach to global medical device manufacturers. The organization plays a pivotal role in advising clients regarding upcoming projects, offering insights into suitable toxicology testing or other relevant tests in line with established guidelines. This consultative approach not only aids clients in making informed decisions but also contributes to cost savings, a factor that attracts a growing customer base. Nitin adds, “Even the world's top five dental product manufacturers are counted among our clients. Furthermore, we extend an open invitation to clients for surprise visits. This transparency stems from the fact that clients often label their products as successful, even when results might indicate otherwise. By involving them at every stage, clients gain a clear perspective on product issues and their impact on results. This open-door policy fosters mutual growth and understanding.”

Additionally, CBS houses a Quality Department to me­ticulously oversee its preclinical laboratory, sanc­tioned by the central government's CCSEA, responsible for control and supervision of experimental animals. Quality parameters span animal health, air quality, and temperature quality, with continuous oversight at every study stage as per SOPs, where any de­viations are promptly addressed. Ad­hering to OECD and ISO 10993 guide­lines, CBS conducts tests tailored for specific product launches in various markets. With a focus on quality, CBS is accredited as ISO 17025 with plans to venture into GLP.

In Dr. Yogesh's words, “Our future roadmap includes offering comprehensive testing services encompassing safety testing branches: ecotoxicity, Entomology, Biocompatibility for medical device, chemical, and analytical testing, all under one roof. Also, we carry out some research projects for our internal research and development. We're actively engaged in three projects currently: anti-cancer activity, arthritis sensors, and pain management therapy for cancer patients. These technologies will be patentable shortly, aligning with our research division's market outreach.”

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