Dr Ramesh Jagadeesan

VP & Head – Analytical Services

The global pharmaceutical analytical testing market, valued at $9.74 billion according to Mordor Intelligance, is projected to reach $14.58 billion by 2030, growing at a CAGR of 8.41 percent during the forecast period. In this promising landscape, Recipharm stands out as a leading player. With development and manufacturing sites across Europe, Israel, India and the US, Recipharm today is not only one of the world’s largest CDMOs but also a frontrunner in pharma analytical testing.

The company offers a wide range of technology-driven solutions and services. As a full-service CDMO, its expertise span early stage development to manufacturing and commercialization, while offering expert services including tech transfers, analytical services and regulatory compliance. It works across oral dosage formulations, sterile delivery and advanced therapies.

“With regulatory frameworks becoming increasingly stringent, pharmaceutical analytical testing has become highly specialized, focusing on specific drug substances and driving greater adoption of advanced technologies. At the same time, pharmaceutical companies are narrowing their focus to particular dosage forms, often establishing dedicated facilities for each..

However, building and maintaining all the required capabilities in-house across multiple dosage types is extremely challenging. This is wherecontract development and manufacturing organizations (CDMOs) like Recipharm play a critical role”, says Dr Ramesh Jagadeesan, VP & Head - Analytical Services, Recipharm.

State-of-the-Art Center of Excellence

Pharmaceutical Analytical Testing is part of Recipharm’s core expertise and key flagship offering. In this cross-company service, Recipharm provides Product Characterization & Development, Pharmacopeial Testing & Verification, Impurity Identification, Stability Testing, and Release Testing, for both clinical and commercial use.

What sets Recipharm apart is its ability to deliver these services across all dosage forms: oral solids, topicals and parenterals alike. Central to this capability is Recipharm’s Center of Excellence (CoE) in Bengaluru, which plays a pivotal role in supporting the company’s diverse analytical testing operations across multiple dosage types.

A key philosophy behind Recipharm’s best-in-class analytical testing services has been continuous diversification and expansion of its portfolio. The Bengaluru CoE undergoes regular upgrades, with technical and service enhancements introduced regularly. Recent developments include the establishment of a parenteral development lab equipped with sterility, endotoxins and biomicrobiological capabilities, as well as the addition of In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT) capabilities.

To align with evolving industry needs , Recipharm has also setup a specialty lab focused on nitrosamines testing, elemental impurity analysis, extractable & leachables testing, and unknown impurity identification. With this comprehensive suite of services and advanced inrastrucutre, the Bengaluru CoE has positioned itself as a one-stop solution for pharmaceutical analytical testing requirement.

“At Recipharm’s Centre of Excellence in Bengaluru, we are committed to addressing our customers’ evolving needs through operational excellence, scientific expertise and strong customer engagement. Our service portfolio covers a comprehensive range of stability studies, including Real Time or Room Temperature Testing, Accelerated/Intermediate Studies, Freeze-Thaw Stability Study, Photostability Study, Bulk Hold Stability Study, and Period After Opening (PAO) Stability Study, among others.

Beyond this, our laboratory is equipped to detect a wide spectrum of known & unknown n-nitrosamine compounds, across drug substances (APIs), drug products, excipients, container closure systems, and process components”, says Dr Ramesh.

Addressing Complex IVPT & IVRT Challenges

Due to their sophisticated nature, developing robust and reproducible IVPT and IVRT method is a significantchallenge for any pharmaceutical companies, largely because of the inherent variabilities in formulations. Biological variabilityoften affects the reproducibility and reliability of results, while the set up and maintainanceof diffusion cell apparatus demands specialised technical expertise, presenting yet another major hurdle.

To overcome these challenges, Recipharm’s CoE has developed standardized protocols to ensure consistency across all studies and prepared comprehensive documentation to support regulatory submissions. In addition,the CoE has implemented stringent quality control measures for diffusion cell operation and established standardized practices for skin sourcing, preparation and handling to further enhance consistency and reliability

Mitigating E&L Testing Risks with Utmost Safety

In extractable & leachable (E&L) testing, patient safety is a primary concern for pharmaceutical companies, as harmful substances may migrate from packaging materials, container closure systems or medical devices into drug products. While regulatory frameworks are highly stringent across geographies, challenges such as the absence of standardized analytical methodologies, along with uncertainties around compound identity & toxicity, continue to pose significant hurdles.

To address these issues, Recipharm’s CoE has setablished a comprehensive set of risk assessment and mitigation practices. These include the use of safe and sustainable pharmaceutical and biopharmaceutical container closure systems, systematic gathering of MOC to ealuate interactions with drug products and the experimental design of proposed CCS, among several others .

Technology & Compliance – The USP

Recipharm’s Bengaluru facility, certified by US FDA and CME, upholds stringent quality control systems that meetthe highest international standards. Demonstrating its world-class capabilities, the CoE holds ISO 9001, ISO 14001 and ISO 45001 certifications and has been approved by leading regulatory authorities worldwide, including the US FDA, PMDA (Japan), TGA (Australia), NDA (Uganda), HA (Belarus), ANVISA (Brazil), Ministry of Health - Turkey, Drug Controller of India, and EMA (issued by FAMHP-Belgium).

To maintain alignment with the latest industry standards and compliance frameworks, the CoE undergoes annual audits by globally recognized bodies such as the US FDA, MHRA, and EU GMP, ensuring that clients remain fully compliant with regulations across their markets.

“Dedicated to supporting customers with stand-alone analytical requirements, the size and flexibility of our Bengaluru CoE laboratories allow rapid project initiation and concurrent activities. Our proven capacity, experience and expertise in managing extensive stability programs help pharmaceutical companies significantly reduce time-to-market. What truly sets Recipharm’s Bengaluru CoE is our deep domain knowledge, global expertise paired with local insight, advanced and customizable technology, and integrated support across product development and manufacturing”, adds Dr Ramesh.

Recipharm’s CoE also leads the way in technological innovation. Guided by QbD (‘quality by design’) , it leverages high-end automation tools and latest software to ensure scientific precision and systematic product development. The result is output that consistently meetsinternational quality standards, complies with all necessary regulations and exceeds client expectations.

With over 500 concurrent stability studies underway, the CoE is managed by a team of highly experienced scientists and equipped state-of-th-art mass spectrophotometers and other advanced instruments, enablingclients to overcome resource constraints, shorten development timelines and optimize costs.

The Way Forward

Sharing his vision for the future, Dr Ramesh notes, “At Recipharm, we enursue a multidimensional growth strategy that spans across all verticals of the pharmaceutical industry. The recently-inaugurated parenteral and sterility endotoxin laboratories will significantly strengthen our capabilities and expand our capacity in parenteral product development.

Looking ahead, we will continue to align our growth and expansion initiatives with evolving customer needs and dynamic market demand”.

Dr Ramesh Jagadeesan, VP & Head – Analytical Services,  Recipharm

Having completed his Masters and PhD in Pharmaceutical Sciences from The Tamil Nadu Dr. MGR Medical University, Dr Ramesh is a seasoned pharma R&D professional with over 27 years of experience across number Indian and multinational conglomerates – analytical & formulation lab setup and regulatory approvals being his key areas of specialization.

QUICK FACTS

Year of Inception: 1995

Office Locations: Headquartered in Stockholm (Swe­den), with 17 manufacturing and R&D facilities across US, Europe, Israel and India (CoE in Bengaluru)

Key Services: Pharma analytical testing, product development, manufacturing, technology transfer, regulatory compliance and many more.