Under the microscope: Graeme Lowe, Catalent

Graeme Lowe, Director of Development and Analytical Solutions at Catalent, discusses outsourcing pharmaceutical development and analytical solutions.

In March 2012, Catalent Pharma Solutions completed the construction of its new Development and Analytical Solutions’ laboratories at its facility in Swindon, UK. From this new laboratory suite, Catalent will offer expert analytical testing, development support and regulatory services to pharmaceutical and biopharmaceutical companies. Graeme Lowe, Director of Development and Analytical Solutions at Catalent, is responsible for the general management of the new facility. “We offer a very broad range of (GMP/GLP) solutions, including characterisation and method development/transfer/validation, cleaning validation, compendial testing, routine stability storage/testing and lot release testing,” Lowe explains. “Each analytical programme is tailored to meet the needs and timelines of our customers. The labs have recently been extended to conduct microbiology, controlled drug and cytotoxic lab tests and we have a purpose-built sample suite and stability storage areas. We also have a wealth of regulatory experience to advise on best practice and help in optimising development and testing.

Graeme Lowe, Director of Development and Analytical Solutions at Catalent

From rapid testing of early candidates to regulatory submission and post approval, we can support customers development and analytical needs by designing creative solutions to solve complex problems and producing reliable, market ready results for virtually any dose form. In Swindon, we have specialty handling capabilities for controlled substances, high potents / cytotoxics, oxygen, moisture and temperature sensitive compounds.”

According to Lowe, there are three reasons to outsource – capacity, cost and capability. “We support European launch testing for many companies based in the US and elsewhere who wish to expand into one or more European markets. Many large pharmaceutical companies’ European sites are focused on a single product or suite of products, so they turn to us as an effective and cost-efficient way of leveraging our broad experience and capabilities. We can also help by overcoming internal resource issues at busy periods with seasonal products or when the company is managing multiple launches. There is an advantage to choosing a development partner that is able to offer a wide range of solutions so that transfer to another organisation isn’t required as a product proceeds to later stages of development, trial, launch and throughout its lifecycle. Smaller and virtual organisations have worked with us in order to gain access to our capabilities, expertise or the drug delivery technologies that may compliment their product. For these companies especially, the regulatory capabilities and very broad experience of new product introduction is unrivalled and we can help in speeding development and finding the most effective launch solution.

“The recent acquisition of Aptuit’s Clinical Trials Supplies business made us the world number two player in the clinical trials space and our worldwide network and breadth of capabilities enable us to support this trend toward global development, clinical trials, launch and commercial supply,” Lowe continues. “The acquisition has added to our analytical services footprint and we have integrated these operations into the wider Catalent network very effectively alongside other, ongoing investment, including laboratory and cold storage capacity investments in Europe and in the US. Supporting customers’ clinical trials is pivotal to many aspects of their product’s successful ongoing development and it is important that is demonstrated to customers.”

Customers are increasingly looking for strategic partners to address significant unmet needs in development programmes and in optimising products. “By consolidating outsourcing in this way they are able to concentrate on their core capabilities in discovery and early-stage development,” Lowe expounds. “In the product itself we are seeing a global shift from drugs being professionally administered to selfadministration or administration by relatively untrained professionals and clearly the forms in which medications are designed are evolving to assist compliance. There is also the ongoing need for formulation improvement to improve bioavailability, convenience or the therapeutic profile of the drug.” Formulation improvement may also increase patient adherence. Better solubility, permeation and absorption of drugs can be achieved through technologies that change the site of absorption or time of release, thus making the base drug or biologic molecules more effective. More precise targeting can also reduce side effects; one of the primary drivers of intentional patient non-adherence.

“We know that the challenges in taking a drug to market are many and varied,” Lowe acknowledges. “With a broad range of capabilities spread across the globe and deep experience in new product introduction, we can configure solutions to meet the specific needs of each customer, for any product, at any stage of their development programme.’’