In an exclusive interview, Ramesh Raju, Head – Validations Services, Merck Life Science India explains the latest scenario in validation services within biopharma industry, his company’s offerings, challenges and technological advancements.
What sets Merck’s Validation services division apart in the industry? How does it contribute to the overall goals and mission of Merck Life Science?
The life science business of Merck serves the biopharmaceutical industry with a purpose to impact life and health with science. In line with this, our Validation Services Labs at Merck support the validation of the aseptic filtration process by which the sterile products are manufactured in the industry, in compliance with the current regulatory expectations across the globe.
We prioritize the validation and provide the results within a quick turnaround time for all injectables including certain molecules like orphan drugs, drugs used in the treatment of certain types of cancers, first-to-file drugs, mRNA based therapeutics, drugs in novel drug delivery systems and so on to support the industry and the patients. From our Validation Services lab at Bangalore, we offer aseptic filtration validation services to biopharma manufacturers in India, the Middle East, Africa, Asia Pacific, Oceania, South Korea, Taiwan, and Latin America, collectively representing 60% of the globe.
What kind of services are you providing to the biopharma and drug discovery companies in India, Asia, and globally?
Drug manufacturers must demonstrate that production equipment is not reactive, additive, or absorptive so as to affect the safety, identity, strength, quality or purity of the drug product. Our services support the biopharma manufacturers around the globe who manufacture their products using conventional stainless-steel equipment to hybrid systems to the completely single-use-technologies as product contact parts in the final fill-finish. We ensure that our services are in compliance with the latest regulations like European Annex 1 that was effective in 2023 and the United States Pharmacopoeia Chapters <665> and <1665> that will be effective in 2025.
“We have simplified our service offerings into classic and advanced so that the manufacturers can find easily what they need.”
We partner with the biopharma manufacturers to support them in managing their process risks and ensure regulatory compliance by coming up with a robust compliant and effective risk-based validation strategy to demonstrate that Merck technologies used in their drug production from Phase I through to market contribute to safe drug manufacturing. We have simplified our service offerings into classic and advanced so that the manufacturers can find easily what they need. Classic level of testing services covers predetermined range of manufacturing process conditions with defined study parameters while the advanced testing services provide higher level of customization that can include simulation of complex manufacturing processes. All our services rely on our qualified and experienced technical team. We offer Bacterial Retention Study, Chemical Compatibility, Integrity Testing, and Extractables and Leachables, followed by Patient Safety.
How has the landscape of validation services in the life sciences industry evolved in recent years, and what trends do you foresee in the near future?
Manufacturing technological advancements, increasing complexities in aseptic processing of novel drug delivery systems, processing of evolving novel drug therapeutics, evolving regulatory changes and changing market dynamics – this evolution will continue for sure for coming decade. This is especially crucial for market players aiming to secure new patents, markets and develop novel drug therapies.
Key challenges that validation services face in the current regulatory environment, and how does your team address these challenges?
The evolving landscape expects that the validation services providers keep themselves updated and upgraded well ahead of the industry. As a vibrant science and technology company, we believe in science as a force for good. We make a positive difference on millions of people´s lives every day through our products, innovative technologies and services. The experience of our validation team, process & product application expertise clubbed with the regulatory knowledge of our senior consultants, in-time and on-site support during regulatory audits make customers opt for Merck’s validation lab to ensure that they are compliant to the existing expectations and beyond.
How has the implementation of automation and digitalization impacted validation services within the life sciences sector?
We make innovative efforts in automating and digitalizing our services to the industry. We initiated this focus at the onset of the pandemic when we changed within a few days from manual paper based reviews and signatures to digital reviews and signatures of protocols & reports. We very quickly adopted to the usage of digital worksheets and data archival. We have automated many of the processes in the lab and we have some ongoing projects, efforts will keep evolving over the coming few years as well. This helps us to be ahead and set an example as a market leader assuring our customers of our quality management systems and data compliance.
“We have automated many of the processes in the lab and we have some ongoing projects, efforts will keep evolving over the coming few years as well.”
