Early-phase drug product development and manufacturing represent a critical stage in the journey from promising drug candidates to viable life-changing therapies. In the fast-paced world of drug development, the collaborative efforts between biopharmaceutical companies and Contract Development and Manufacturing Organizations (CDMOs) have become increasingly prevalent in navigating the complexities of this intricate process.
In this article, we will explore the pivotal role CDMOs play in de-risking and accelerating early-phase drug development, from formulation to large-scale production.
The Evolution of CDMOs
CDMOs have evolved to meet the growing demand for specialized expertise and infrastructure in the pharmaceutical industry. With the CDMO market size estimated at USD 238.47 billion in 2024, and is expected to reach USD 330.36 billion by 2029, growing at a CAGR of 6.74% during the forecast period (2024-2029)1, it is evident they play an important role in the biopharmaceutical ecosystem.
Historically, pharmaceutical companies handled all aspects of drug development and manufacturing in-house. However, today as the industry becomes more complex and competitive, CDMOs are forming an integral part of the supply chain as companies seek integrated and strategic solutions from their partnering CDMO.
CDMOs offering a wide spectrum of services, supporting the entire lifecycle of a drug product from formulation development, analytical method development, scalable manufacturing and packaging through to launch are in demand. Their expertise and dedicated focus on specific aspects of the drug development process make them valuable partners, especially in the early phases when flexibility, speed, and specialized knowledge are crucial.
Advantages of CDMO Collaboration in Early-Phase Development
1. Specialized Expertise:
CDMOs bring specialized expertise, established quality systems, and regulatory compliance knowledge to the table. The diverse range of projects that CDMOs are exposed to and work with creates a wealth of combined experience across all areas of product processing. This expertise is particularly valuable during early phase development, where the unique challenges of different drug candidates require tailored solutions. CDMOs can provide insights into formulation strategies, analytical methods, and regulatory considerations that may not be readily available within a biopharmaceutical company.
2. Accelerated Development Timelines:
One of the primary advantages of partnering with a CDMO is the potential for accelerated development timelines. CDMOs are equipped with state-of-the-art facilities, technologies and technical know-how that allow them to streamline processes and expedite development. This is especially critical in the early phases when speed to market can significantly impact a drug’s success. The ability to leverage a CDMO’s existing infrastructure together with its expertise can result in faster formulation development, analytical method validation, and overall progress through the development pipeline
3. Cost Efficiency:
Collaborating with a CDMO can offer cost advantages, particularly for biopharmaceutical companies navigating the uncertainties of early-phase development. CDMOs employ technological innovation to optimize production efficiency, providing manufacturing technologies at the appropriate scale which in turn helps manage operational and project costs. Typically operating on a fee-for-service model, allows biopharmaceutical companies to optimize costs by only paying for the specific services needed at each stage or project milestone. This flexibility is particularly beneficial in early-phase development, where adjustments to the development plan may be necessary based on evolving data and regulatory feedback.
4. Risk Mitigation:
Drug development inherently involves risks, and early-phase development is no exception. CDMOs can serve as strategic partners in risk mitigation by sharing their experience to navigate challenges effectively. This collaborative approach allows pharmaceutical companies to tap into the CDMO’s knowledge base, anticipate potential issues, and implement proactive measures to mitigate risks before they become significant hurdles.
Many leading CDMOs offer integrated, scalable drug development, manufacturing and packaging solutions. Streamlining supply chains and reducing complexity is a crucial aspect of risk mitigation. Partnering with a CDMO that can provide an end-to-end solution throughout the lifecycle helps biopharmaceutical companies achieve reliable and scalable manufacturing, aiming at a seamless transition from clinical trials to commercialization.
PCI Pharma Services Accelerated Early Phase Solutions
PCI Pharma Services is a world-leading CDMO. We are dedicated to ensuring the success of life-changing therapies from the very early stages of development, through the clinical lifecycle to commercialization and beyond. With over 35 years of experience in the processing of highly potent molecules and over 25 years of experience in lyophilization and sterile fill-finish, we combine our heritage with state-of-the-art technologies and our highly skilled workforce to deliver a seamless end-to-end solution for each and every drug product.
A global network of clinical and commercial scale packaging centers of excellence support our development and manufacturing services. These include specialist high potent and injectable packaging capabilities, delivering both clinical supplies and commercial products to patients globally.
Pharmaceutical and Analytical Development
At PCI, we specialize in pharmaceutical development, taking both small and large molecules from the earliest stages of development to commercialization. We provide a wide range of solutions to help clients bring their molecules through the development process to ensure stability, efficacy and patient safety.
From developing formulations that address early phase challenges such as unknown toxicology, poor solubility, stability challenges, and compatibility concerns, to creating simple, phase-appropriate formulations that facilitate dose escalation studies and rapid assessment of safety, our team of scientific experts ensures that drug products are developed safely and efficiently. We understand the complexities of the pharmaceutical development process and work closely with our client partners to ensure that their product milestones are met.
Dedicated in-house analytical support laboratories help streamline the development and manufacturing supply chain. From analytical testing, method development and validation to ICH stability testing, our comprehensive sterile and oral solid dose analytical solutions ensure the development and supply of quality, safe and effective drug products whilst providing valuable CMC data to support regulatory submissions.
Scalable, flexible manufacturing technologies
PCI provides full development and manufacturing services for both investigational and commercial products, including sterile liquids and highly potent oral solid dose drug products requiring specialist handling.
Our strength lies in the integrated nature of our services, combining formulation and analytical development with GMP clinical manufacturing and packaging through a full cross-functional project team, coordinated by an experienced team of project managers.
Utilizing our state-of-the-art facilities, we offer unrivalled capabilities and a true focus on customer need. We provide clinical manufacturing of multiple dosage forms for investigational use including solid oral dose, liquids, semi-solids and aseptic fill-finish processing.
1. Sterile manufacturing solution
With a focus on supplying life-changing therapies to patients as quickly and efficiently as possible, PCI utilizes advanced robotic gloveless isolator sterile filling technologies. These platforms are located at a PCI clinical site in a hub of early phase clinical development activity in San Diego, US. This facility operates a Cytiva Microcell unit a larger scale Cytiva SA25 platform.
Utilizing the latest advancements of robotic sterile filling technologies, these platforms provide flexible aseptic fill-finish solutions for both small and larger-scale clinical production runs across a variety of dosage forms including vials, syringes and cartridges for use in auto-injectors, addressing our clients’ scalable aseptic manufacturing needs from preclinical, through First in Human (FIH) trials and beyond, delivering products to patients safely and efficiently.
The Microcell platform offers fully automated, gloveless filling, performed through closed robotic isolator technology that provides both small batch flexibility and standardized manufacturing. The agility of this technology make it suitable for the production of both personalized medicine batches, preclinical and early phase clinical trial supplies delivering true speed to patients. Superior drug product quality is assured through advanced automation, removing the need for operator intervention during the filling process and limiting product contact. Importantly, the Microcell technology can fill up to 1,200 vial units per batch with fill volumes ranging from 1.0 –50mL.
Providing a scalable aseptic solution in support of clients progressing through the clinical lifecycle towards commercialization, the SA25 Aseptic Filling Workstation is a larger-scale, gloveless, isolator-based filling technology offering small and larger scale batch production of up to 20,000 units, supporting fill volumes from 0.2 – 50mL. This technology provides flexible manufacturing solutions with the ability to fill multiple delivery device formats including vials, syringes and cartridges through the aseptic process.
For both the Cytiva Microcell and SA25 technologies, precise, programmable robotic functions cover all aspects of the fill process, including isolator leakage tests, VHP sterilization of the container closures, filling into the CCS of choice, capping and batch delivery. Importantly, they are also compatible with RTU containers and closures, removing the container and closure preparation stage, aiding speed of delivery of a quality and sterility assured drug product.
2. Oral Solid Dose – High Potent Scalable Manufacturing
Traditional product development of a formulated solid oral drug for Phase I clinical trials typically involves a range of activities including initial compatibility studies, analytical method development, prototype development, short-term stability, process/formulation refinement, Phase I method validation, and finally, clinical manufacture. Xcelodose® micro-dosing technology, delivering drug directly into capsules or vials removes the need for initial formulation development and the associated stability testing, leading to faster first-in-human (FIH) studies and cost efficiencies.
The Xcelodose® is a fully programmable system ensuring exceptional levels of accuracy and precision whilst minimizing wastage of valuable drug substance. We are proud to offer multiple options of micro-dosing technology, delivering flexible batch volume requirements to meet clinical needs. Xcelohood™ and Xceloprotect™ containment technology, further enhance our contained solutions for the development and manufacturing of highly potent drug products, allowing us to safely supply clinical products with an occupational exposure limit (OEL) as low as 0.01µg/m3.
SpeedSolutions™
Our combination of core CDMO services and complementary speed solutions accelerate your drug product from development to commercialization and beyond.
Supporting your early-phase trials and establishing proof of concept, efficacy and stability of your drug candidate in the fastest possible time, we will accelerate your product journey through the earliest stages of development. Our Supply Management and Readiness Team (SMART ™) are there to support your entire clinical journey, mitigating risk and managing critical regulatory milestones.
SMART First Human Dose (FHD)
PCI offers industry leading expertise in Supply Project Management rapidly transitioning a solid oral dose drug from candidate selection to first human dose clinical trials. Our SMART FHD team can provide a development path that will be months faster to first human dose clinical trials and years faster to market than traditional formulation development timelines by managing the following:
- Develop and manufacture min & max drug-in-capsule dosages
- Qualify test methods and conduct a bracketed stability protocol including packaging, storage, and testing and provide reports
- Manufacture Drug-in-Capsule (DiC) dosages, bottle, and label for clinic use
- Compile all CMC information for regulatory submission
- QP release the clinical drug
- Manage inventory and distribute the drug for clinical use
- Supply project management to organize and oversee all aspect of the development project
Through SMART FHD and removing drug development from the critical path, in addition to time efficiencies, clients can expect significant financial savings together with rapid access to clinical data to help them progress to the next phase of their clinical trial and next round of investor funding.
Case Study: Successful Collaborations in Early Phase Development
Accelerating Time to Clinic with Robotic Sterile Fill-Finish
A European virtual biotech company approached PCI Pharma Services seeking integrated drug development, manufacturing, packaging and distribution support to progress their innovative siRNA based injectable therapy from preclinical studies to FIH clinical trials. The client company was subject to aggressive timelines for their clinical program, seeking an end-to-end clinical drug product development and packaging solutions to ensure their lead drug candidate was available for Phase I trials within a five month timeframe.
PCI’s early phase proposition of sterile filling, clinical packaging and distribution provided by our San Diego, US facility was the ideal solution for the project as all activities would be delivered from a single site. One of the critical factors during the client company’s assessment was PCI’s innovative advanced robotic gloveless isolator aseptic vial filling platform, as the client wanted to de-risk the filling step of their valuable product as much as possible.
The Cytiva Microcell Vial Filler used for this early phase clinical project provided small batch flexibility with closed robotic isolator technology. With multiple sources of risk eliminated through single use parts, pre-sterilized flow paths, RTU containers and removal of human intervention, an enhanced quality and sterility assured drug product for FIH dosing was delivered.
Providing a truly integrated, end-to-end solution, streamlining the supply chain, mitigating risk and reducing timelines, the onsite PCI clinical packaging team labeled and packed the vials for shipment to clinical sites well in advance of the initiation date set for the client’s Phase I trial.
Conclusion
The collaboration between biopharmaceutical companies and CDMOs is increasingly shaping the landscape of early-phase drug product development and manufacturing. The specialized expertise, accelerated timelines, cost efficiency, and risk mitigation offered by CDMOs have become instrumental in navigating the complexities of this critical phase in drug development.
As the pharmaceutical industry continues to evolve, CDMOs will play an even more pivotal role in driving innovation, leveraging advanced technologies, and ensuring regulatory compliance. Looking ahead, the future promises continued advancements in drug delivery technologies, digitalization, and sustainability initiatives within the CDMO landscape. As pharmaceutical companies seek strategic partners to enhance their capabilities and address the unique challenges of early-phase development, CDMOs are poised to remain key contributors to the success of life-changing therapies that ultimately improve patient outcomes.
- https://www.mordorintelligence.com/industry-reports/pharmaceutical-contract-development-and-manufacturing-organization-cdmo-market
Author: Jerome Detreille, Senior Director Business Development EMEA
After graduating from Strasbourg University of Pharmacy, France, Jerome spent thirteen years as European Director of Business Development in Catalent for sterile injectables, before moving to Penn Pharmaceutical Services as Senior Director New Business Development in 2012. Here, he was part of the Executive Team who built the potent Contained Manufacturing Facility (CMF), which won the ISPE Facility of the Year award for Facility Integration (2014). In 2014, PCI acquired Penn Pharmaceutical Services and Jerome continues to act as Senior Director Business Development EMEA to support the growth of PCI especially in the development and manufacturing of high potent OSD and sterile and lyophilized drug products.
CDMO Support: Catalyst for Success in Early Phase Drug Product Development and Manufacturing by Jerome Detreille, | As seen in The PharmaNetwork | February 2024.
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