Pharmaceutical companies of all sizes now routinely outsource many of their research, development and/or manufacturing requirements to contract organizations around the world. Outsourcing enhances the overall performance of pharma companies by enabling them to focus their resources on core activities of understanding the fundamental causes of disease states, discovery of novel therapies, and the eventual marketing and distribution of the finished commercial dose forms. Accordingly, the contract research, development and manufacturing industry continues to grow, driven by an expanding array of customer requirements presenting new challenges for outsourcing partners and CMOs.

Key requirements throughout the industry are reliability, supply chain security and quality and so, for companies considering outsourcing, trust in their partner organizations’ ability to deliver is a critical factor underlying the partner selection process. However when numerous partners contribute to the supply chain it can be harder to manage quality and supply chain controls effectively. By establishing a smaller number of flexible suppliers, that provide early-stage expertise and pre-clinical studies as well as large-scale manufacturing and global supply at commercial stages, outsourcing complexity and risk can be greatly reduced. Johnson Matthey Fine Chemicals is well positioned to provide such a range of pharmaceutical API research, development and manufacturing services through its Custom Pharma Solutions offering. Services include API development, from pre-clinical through to commercialization, supported through an extensive portfolio of differentiating technologies across our network of eleven global sites. Collaborative working is a core principle of the Fine Chemicals Division, enabling the Custom Pharma Solutions teams to draw upon the expert capabilities of colleagues specializing in the Division’s other offerings: Catalysts, Controlled Substances and APIs & Life Cycle Management.

Vicinity Can Improve Collaboration

Customers often value having their outsourcing partners located near to their own facilities and operations, as this can enhance communications and allow for improved levels of collaboration, especially at key stages of product development. As an example, pharma and biotech companies at the Boston biotechnology hub are able to work closely with Johnson Matthey scientists at our nearby facilities in Devens and North Andover, in Massachusetts. Similarly, our recently expanded Cambridge, UK, facilities are well-placed to serve close collaborations with biotech and pharma companies in many sciences parks in the Cambridge and wider UK region.

Specialist Chemistry Capabilities

A further challenge for the outsourcing industry is meeting customers’ growing needs for specialist chemistry capabilities, as biotech and pharma companies increase their understanding of the fundamental causes of diseases and consequently develop highly complex and innovative products. We are seeing increasing demand for our expertise in solving challenging chemistry and engineering scale-up problems, to enable effective and efficient synthetic routes. Customers need access to a diverse range of specialist technologies and Johnson Matthey Fine Chemicals has an extensive range for solving complex chemistries. Our technologies include a world-class portfolio of chiral and catalyst technologies, with both chemocatalysis and biocatalysis platforms; drug-conjugate and polymer-conjugate technologies; chromatography from small- to large-scale; process and analytical technologies, and specialism in solid form sciences.

These are enhanced by world-leading expertise in handling controlled substances and highly potent APIs. Additionally we have acquired the Pharmorphix solid form sciences business and integrated this into our Cambridge facility, which is a center of excellence for catalysts, chiral technologies and API development. The challenges with materials such as drug conjugated to ligands or polymers are not limited to their synthesis. For example at Johnson Matthey, we have also invested in specialized process, purification and analytical technologies such as membrane-bound separation technologies, diafiltration, and instruments for analyzing the impurity profiles of high molecular-weight products.

Improvement of Process Cost-effectiveness

A final concern for pharmaceutical companies is improving their process cost-effectiveness without impacting on quality or innovation, and we have observed growing interest in combining catalytic technologies to achieve this. For example, biocatalysis and chemocatalysis are highly complementary to each other and can be integrated for optimal process efficiency, but few contract service providers have the breadth of capability in both chemo- and biocatalytic technologies. We routinely evaluate an array of chemo- and biocatalytic tools in order to develop the most cost-effective solution for a customer’s needs. In addition, Johnson Matthey continues to undertake significant research into applying catalysts in novel and innovative ways to enable new transformations, which will provide even more elegant and effective ways of suitable manufacture in the future.

Sustainability

Sustainability is a particularly important focus for Johnson Matthey as a whole and will remain an ongoing concern for the wider industry. The company has made significant progress in recent years in reducing its own carbon emissions and footprint, and establishing and maintaining best practices for efficiency, including reducing material use and production of waste.

Meeting Customers’ Needs

As the pharma industry continues to evolve, it will be critical that outsourcing partners remain equally adaptive in order to meet customers’ changing needs. In addition to investing in our pharma-focused capabilities and technologies, we continue to place great emphasis on the innovative capabilities across the wider group, in order to be ready for future demands. For example, Johnson Matthey is a leading advanced material science company with broad expertise in understanding how to control particle morphology and size to an exquisite degree. In the area of continuous processing technologies we have 25 years of experience through our activities in the petroleum industry. We are looking at how we can bring these capabilities together with our Custom Pharma Solutions offering to meet the emerging and future requirements of our customers and their developing needs for more effective, technology enabled outsourced services. We also believe that combining technologies will deliver much greater benefits for the industry, such as combining catalysis capabilities or purification science with continuous processing.