Contract Development and Manufacturing Organizations (CDMOs) play a crucial role in supporting the pharmaceutical and biotech industries by providing expert solutions for drug development, manufacturing, and clinical trial services.
When partnering with a CDMO, to ensure a robust supply chain it is vital that your preferred CDMO has global reach together with flexible, scalable solutions to support your trial from early phase through to commercialization.
The importance of a CDMOs scalability and global capabilities cannot be underestimated and key considerations include:
The scalability of CDMOs’ service offering is critical for supporting clinical trials effectively. It not only enables adaptive responses to changes in trial requirements but helps manage risks, reduces time-to-market, and contributes to overall cost efficiency, ultimately facilitating the successful progression of clinical trials from early phases to regulatory approval.
- Flexibility in manufacturing capacity: A CDMO with scalable technologies is able to adapt its manufacturing capacity to accommodate the changing needs throughout the clinical lifecycle, ensuring an adequate supply of investigational products while avoiding underutilization or excessive costs.
- Scale-up without transfer: If a clinical trial progresses successfully and moves to later phases, the demand for the investigational product can increase significantly. Partnering with a CDMO able to support all phases of the clinical lifecycle and global requirements mitigates the need to transfer the manufacturing and/or packaging process to an alternative supplier, delivering both time and cost efficiencies.
- Reducing time-to-market: The ability of a CDMO to quickly scale up production can significantly reduce the time to commercialization. Rapid production scalability can help meet clinical trial timelines and accelerate the overall drug development process through to commercial launch.
- Mitigating supply chain risks: Unforeseen events, such as supply chain disruptions or increased demand, can impact the availability of critical trial supplies. A CDMO able to scale to meet demand can provide a buffer against such risks by swiftly adapting production levels in response to changes in demand or supply chain challenges.
- Meeting global demand: If a clinical trial generates positive results and leads to regulatory approval, the demand for the drug may surge globally. A CDMO with a scalable, global service offering can help ensure a smooth transition from clinical to commercial-scale manufacturing and packaging, meeting the increased demand while maintaining product quality and consistency with local, regional supply.
PCI Pharma Services – Your clinical trial destination. Our world.
PCI is a leading global CDMO, truly spanning the cycle, connecting development and commercialization, de-risking the supply chain providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success.
We provide a global service with localized focus, delivering over 200 clinical protocols a year in over 100 countries, utilizing best-in-class technologies combined with our experienced and dedicated teams. Our global network of innovative centers of excellence across Asia Pacific, Europe, North America and Canada provide a seamless service, supporting the global supply of investigational medicines with pharmaceutical development, clinical drug product manufacturing, packaging, labeling, storage, distribution and full returns service.
Our clinical to commercial scale capabilities use geometrically similar equipment trains providing true life-cycle management for all dosage forms including sterile liquids, lyophilized liquids, high potent oral solids and non-potent solid and semi-solid drug products.
Supporting early phase clinical trials, our drug product manufacturing facilities utilize flexible, API saving technologies such as Xcelodose® micro-dosing encapsulation platforms and robotic aseptic Cytiva Microcell isolators for filling vials.
Harnessing our experience and expertise to deliver a seamless global scalable solution, combining formulation and analytical development with expert clinical trial supplies, we can optimize formulations and manufacturing processes to scale-up in support of late phase clinical trials and transfer to larger scale manufacturing technologies across our global network to provide regional clinical supplies.
For example, for preclinical / first in human studies in Asia Pacific our client partners can leverage the benefits of our Cytiva Microcell fully automated gloveless isolator technology at our Melbourne, Australia facility for aseptic vial filling. As trials progress and sponsors seek to include wider populations and globalize trials in preparation for launch, our larger scale Cytiva SA25 platform in San Diego, USA can aseptically fill larger volumes with the added flexibility of filling vials, syringes and cartridges for autoinjectors.
Precise, programmable robotic functions cover all aspects of the Microcell and SA25 fill process, including isolator leakage tests, VHP sterilization of the container closures, filling into the CCS of choice, capping and batch delivery. The advanced robotic platforms are also compatible with ready-to-use (RTU) containers and closures, removing the container and closure preparation stage, aiding speed of delivery of a sterility-assured drug product.
These innovative robotic aseptic fill-finish platforms enhance our renowned sterile and lyophilization capabilities across our global network. They not only expedite the filling process with automation but being able to pivot between filling different sterile medications into multiple dosage formats, brings even broader sterile fill-finish solutions to PCI clients across the entire drug product lifecycle bringing therapies to market with increased enhanced quality and sterility assurance.
Streamlining clinical supply chains
Complementing our scalable drug manufacturing solutions, our global packaging centers of excellence offer a comprehensive range of flexible labeling and packaging capabilities across multiple delivery systems including bottles, blisters, vials, ampoules, syringes, prefilled syringes, autoinjectors, cartridges and medical devices. This truly integrated, global proposition of end-to-end tailored solutions can help mitigate risk and reduce complexity in the drug product supply chain.
Meeting the dynamic needs of the clinical trial landscape, at PCI we provide a collaborative, creative and tailored approach to deliver upon our mission of being the bridge between life-changing therapies and patients. By combining our expertise in drug product manufacturing and packaging with the latest advanced scalable technologies across our global network provides a valuable integrated solution, simplifying the supply chain while delivering time and cost efficiencies across the development to commercialization lifecycle.
Development to commercialization and beyond | As seen in Australasian Biotechnology | Volume 33 October 2023.