True Integration is Integral to Providing One-Stop-Shop CDMO Services

A truly integrated CDMO with the right structural foundation and top-down commitment can provide tremendous benefits to biopharmaceutical customers.

Rising Demand for Contract Services

The value of the global pharmaceutical contract manufacturing market is expected to reach $95.9 billion by 2025, with the API segment accounting for the largest share but the final drug formulation segment growing at the fastest rate.1 Growth overall is being driven by rising demand for medications around the world, due to the aging population, increases in chronic diseases and growing wealth in emerging economies. Pharmaceutical companies are increasing their dependence on outsourcing partners to achieve increased efficiencies and gain access to advanced technologies.

Renewed Interest in the One-Stop Shop

Over the past decade, innovation in the pharmaceutical industry has shifted to emerging pharma and biotech companies that lack the infrastructure, capabilities and resources necessary to support the entire drug development and commercialization cycle. For these smaller companies that must rely heavily on outsourcing partners, it is much more efficient to develop strategic relationships with integrated CDMOs.

Larger pharmaceutical companies are also realizing that, by working with a company like Piramal Pharma Solutions, it is possible to take a candidate from post-discovery to commercialization with one point of contact and without the need to manage multiple suppliers or the cost and time delays associated with tech transfer between different service providers. Product knowledge and expertise are retained throughout the project lifetime, facilitating collaboration and process scale-up.

Time is of the Essence

There has never been more pressure for pharmaceutical companies to develop new drugs more quickly and at lower cost. Integrated CDMOs that operate as true one-stop shops help sponsors reduce time to the clinic and the market while also controlling costs and often providing access to unique, advanced capabilities. With one contract, one global master service agreement and one quality agreement, integrated providers help simplify the drug development process.

Integration is Essential

Integrated offerings are only effective, however, if all of the services are harmonized and presented to the customer as a single system. An integrated offering must not simply be different businesses linked together, but a single business at the operational level. Commitment must come from the top down, with establishment of a company philosophy and systems that create a single customer-facing solution that facilitates easy customer interaction.

Piramal does not consider integrated projects as projects, but as programs. We have installed software to manage our integrated programs and hired experts to serve as program managers. All interactions with clients from verbal to written communications follow the same protocols. The technology transfer process is headed by the program manager, who ensures that all necessary documents are exchanged, goals and timelines are agreed upon and met and routine communications, both internal and external, are managed effectively.

Understand Your Value Proposition

Choosing a service provider ultimately comes down to risk tolerance, which is different for every pharma company. It is therefore essential for integrated CDMOs to have a clear understanding of their value propositions and clearly communicate those benefits to potential clients. Commitment to the company’s mission must also be embedded in the hearts and minds of all employees.

Piramal has grown through acquisition, building capabilities in drug substance and drug product development and manufacturing. Our leaders have experience in integrated offerings and leverage our global network to provide maximum efficiency and productivity. We have facilities for the production of drug substances in lower-cost countries and sites in the West with specialized capabilities for drug product manufacturing, including solutions for highly potent products and antibody–drug conjugates. We are one of the few CDMOs able to offer integrated services for oncology candidates, as well as for candidates targeting other indications.

At present, Piramal is evaluating how to further expand upon our existing capabilities, including the addition of oral solid dose development and manufacturing services. We have the necessary organizational structure in place and are excited to build on our early success as a truly integrated CDMO.

References

  1. $95.94 Bn Pharmaceutical Contract Manufacturing Market, 2025. Research and Markets. 21 2019. Web.

Stuart E. Needleman

Stuart Needleman has recently joined Piramal Pharma Solutions as Chief Commercial Officer and he is responsible for driving all global business development activities for the services business, ranging from discovery services to commercial supply, in both drug substance and drug products. Stu will play a key role in enabling successful growth and execution of PPS offerings.