In an exclusive interview with BioPharma APAC, Mr. Ramesh Raju, Head of Operations for BioReliance Validation Services at Merck Validation Lab, sheds light on Merck's Validation Services, their role in the life science industry, and their notable contributions during the COVID-19 pandemic. With a global reach and unwavering commitment to quality, Merck's Validation Lab has become a preferred partner for pharmaceutical companies in their quest to bring innovative solutions to the market. Mr. Raju also outlines the lab's plans for the future, highlighting their dedication to human progress and innovation in the life science sector.

Could you please provide an overview of Merck's Validation Services and its mission within the life science industry?

Merck's Validation Services, an integral part of the life science sector, is dedicated to the human progress. The services support the Biopharmaceutical manufacturers around the globe in managing their process risks in the injectables manufactured by aseptic processing and ensuring regulatory compliance. The services team partner with the manufacturers in assessing and mitigating the process risks through appropriate validation strategies, from Phase 1 through to market to show that Merck technologies contribute to safe drug final fill. From the past 20 years, the Merck Validation Services lab in India is committed to offering top-tier services to its clients all around the world through the validation of various sterile products produced by aseptic processing. Spread over a 10262 sq. feet area at Merck Peenya site in Bangalore, the validation lab provides services to biopharmaceutical manufacturers around the globe. 

The following are a few of the services the lab provides:

All the regulations require that the validation studies establish that the product contact parts used during the manufacture of injectables are not reactive, additive or absorptive to the product with which they are in contact with. They also require that the studies prove that the process produces a sterile product and ensures safety of the patient.

• Bacterial Retention: This study simulates the scale down model of the product batch size with the critical processing parameters and confirms that the aseptic filtration produces a sterile product.
• Chemical Compatibility: This study confirms that the product contact parts are chemically compatible with the product at the processing conditions like temperature and duration of contact during the manufacturing process. 
• Integrity Testing: This test provides a product-based integrity test limit specification, a non-destructive method of integrity test for the filter, which can be used prior and post filtration to confirm that the filter used during the manufacturing is integral.
• Extractables and Leachables followed by patient safety: These services provide details of process equipment-related leachables (PERLs) that could be found in the final product followed by assessing of the same from patient safety perspective. 

How did Merck's Validation Lab contribute to the efforts of vaccine manufacturers during the COVID-19 pandemic, and what were some of its notable achievements in this context?

Merck has been the company behind the scenes supporting pharma and biopharma companies over the years and more so during the Covid-19 pandemic. The company has stepped up and provided support for vaccine manufacturers in their race for emergency use authorization of vaccines. Merck’s  Quality Management System had an in-built “Business Continuity Plan” (BCP) for many years before the pandemic. Therefore, while the complete world was shut down during the various phases of the pandemic, the Validation Services Lab of Merck at Bangalore was up and running as per the well-established BCP. This helped us in supporting humanity in times of emergency by delivering the validation of various buffers used in COVID vaccine manufacturing, validating the single-use technologies used in the fill finish of vaccine manufacturing, validation of emergency molecules like Remdesivir, validation of antifungals like Amphotericin – not just for the biopharmaceutical manufacturers in India but for all the manufacturers around the globe as all other labs that deliver such services were closed during the period. The culture and commitment of Merck’s Validation Lab team were evident in their dedication to go above and beyond the obvious during such challenging times.

Could you elaborate on the global markets that Merck's Validation Lab serves and the significance of its validations in these regions?

The Validation services lab of Merck at Peenya site in Bangalore provides aseptic filtration validation services to biopharmaceutical manufacturers in India, South Korea, Taiwan, Asia Pacific and Oceania, Middle East, Africa, and Latin American countries, which together make up a sizable share of the global life science and pharmaceutical market. The biopharmaceutical manufacturers in these geographies form almost 60% of the globe. The Bangalore lab boasts of the highest capacity, trained & qualified validation specialists, quality compliance and the best turn around times that support our customers to file their molecules in regulated markets in time, meet their business needs and assured compliance. We also have other Validation services labs of Merck that serve biopharmaceutical customers in the US, Western Europe, China and Japan.

What are some specific types of molecules that the lab typically validates, and how does it ensure the highest standards of quality and safety?

The sterilizing grade filters, Mobius® single-use technologies and other product contact parts from Merck used in the fill finish manufacturing step of biologics, vaccines (proteins, polysaccharides, mRNA in Lipid Nano particles, viral vectors, etc…), ophthalmic and small volume  parenteral injections are validated in compliance to the global regulatory expectations, Merck Quality management systems and ISO certifications. While serving humanity we ensure that we pay equal and more attention to the safety of our well trained and qualified staff at workplace, we are certified for maintaining Occupational Health and Safety Management System as per ISO 45001:2018. The range of small volume injectable preparations validated include oncology products (like octreotide acetate inj., monoclonal antibodies (mAbs), fluorouracil inj. etc), hormones (like progesterone inj. and testosterone inj.), cardiovascular drugs (like enoxaparin inj., etc), medicines used in epilepsy (like phenobarbital inj., Phosphenytoin Sodium inj.,) , orphan drugs used to treat rare diseases (like Pegaspargase Injection used to treat blood cancer and Hodgkin’s disease), vitamin & mineral supplements (like Iron Sucrose inj, zinc sulphate inj.,), chemotherapeutic drugs (Cilastatin inj., Meropenem for injection.,), narcotics used in post operative pain management (like Midazolam inj and Ketamine inj) and so on.

In the competitive landscape of 'First to File' molecules, what factors make Merck Bangalore Validation Lab a preferred partner for pharmaceutical companies?

Securing approval for a patented product going off-patent is a critical and fiercely competitive endeavour for the industry players. Being the initial contender to file and attain approval on the "First to File" molecules, grant them an exclusive market share for six months. The key differentiator that sets Merck apart from its competitors in this respect is the priority lane that is provided for validation of such molecules, which is a turnaround time of less than 45 days from the date of filling the validation request. 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 swift processing of their "First to File" molecules, as minimizing the time between filing and approval is of utmost importance. This is especially crucial for market players aiming to secure new patents for drugs transitioning from patent protection.

Looking ahead, what are Merck's Validation Lab's future plans and initiatives to continue supporting the life science industry and its customers?

At Merck, we are DEDICATED TO HUMAN PROGRESS. 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 best-in-class services. 

Merck's Validation lab, as an integral part of the life science sector of Merck, is devoted to following the same ambition. We will continue to stay close to regulatory guidelines, ensuring that our processes and practices align with the highest standards. Moreover, we will foster a culture of innovation, proactively seeking opportunities to push the boundaries of scientific advancement. Our dedicated professionals who form the backbone of our validation lab will remain a key driving force behind our success. We recognize that our customers are at the heart of everything we do, and we will continue to prioritize their needs and provide them with exceptional support. Embracing our commitment to excellence, we strive to surpass industry expectations and advance the progress of the life science industry, together.

arcilla.fran@biopharmaapac.com