What are “3 Key Trends” shaping the CDMO industry in 2023 and beyond? PCI Pharma Services’ chief commercial officer, Tim Roberts, shares his thoughts with Contract Pharma.

Growth in oncology
Scientific progress has transformed the discovery of new therapies and the treatment of cancer over the past decade. As the fastest-growing sector of drug development, oncology has benefited from advancements in science and technology with research scientists having a better understanding of the biology, immunology, and genetics of cancer resulting in more powerful targeted therapies, transforming the way patients are treated.

Many patient populations that were previously treated with nonselective chemotherapies now receive precision targeted immunotherapies that are tailored to their disease. By their nature, targeted cancer therapies are more complex, making their formulation more challenging with many being either highly potent compounds that require specialized facilities, equipment, and contained handling or biological derived immunotherapies requiring sterile processing.

Coupled with challenging processing properties and smaller patient populations, many biopharmaceutical companies seek to outsource the manufacturing and packaging of their oncology drug products to specialist CDMOs with experience and expertise in high potent processing with specialist containment solutions for oral solid dose forms or those with specialist lyophilization and sterile fill-finish processing for injectable dosage forms. This is something that we are witnessing a significant growth in and a trend which PCI Pharma Services have addressed with recent multi-million-dollar investments across our global network of world-class manufacturing facilities delivering best-in-class solutions for both solid oral and injectable dosage forms.

New modalities and the complexity of drug products
Increasingly as therapies become more targeted, drug products are becoming more complex with the growth in the development of biologics and ATMPs such as Cell & Gene therapies taking center stage. Many factors associated with biologics and Cell & Gene therapies result in a more complex supply chain versus their chemical counterparts, for example, thermal stability requirements mean that cold and ultra-cold storage and distribution conditions are a necessity together with specialist frozen packaging.

Manual frozen packaging has traditionally been the industry method of choice and is typically aligned to clinical or small volume niche drug products. However, with the latest advancements in technology, automated processing at low temperatures, now facilitates the processing of larger commercial-scale volumes, providing increased operational efficiencies and reduced quality and safety risks.

With high value life-saving drug products, biopharmaceutical companies are partnering with CDMOs who provide flexible tailored packaging solutions to meet their product needs. Preference to partnering with an end-end solution provider with scalable manufacturing and packaging capabilities supporting both clinical and commercial supplies allows for ease of product knowledge and process data sharing for efficient process development and optimization when preparing for launch and commercialization.

Simplification and security of supply chains
Recent events have put a spotlight on the need for secure and nimble supply chains. Biopharmaceutical companies seek service providers that can provide integrated solutions to support their drug products throughout their development lifecycle to commercialization, mitigating the need to transfer between suppliers therefore reducing supply chain complexity and risk.

Ensuring continuity of supply is vital for our client partners with life-saving drug products and supply chain management is at the heart of our global manufacturing and packaging operations. Providing true supply chain insight, we leverage our industry-leading supply chain management platform pci | bridge™, unlocking productivity with access to real-time supply chain information and digital workflows supporting clinical and commercial supply chains alike delivering drug products to patients when needed.

Given the ever-increasing high value of medicines, particularly for rare diseases and indications such as oncology, operational and supply chain flexibility allows companies to manage effectively through unforeseen supply dynamics. One such risk mitigation strategy our client partners utilize is dual sourcing, from dual market supply, scale-up to address increase in demand, capacity reservation models for back-up supply when needed, this strategy helps safeguard their supply chain.