In this article, Jim Donovan, general manager for Pfizer CentreOne, explores the concept of “lightspeed” development under high-pressure situations, such as pandemics and drug shortages, and how these lessons can be applied to optimise SI development processes to meet rising demand.
Pfizer CentreOne
Every second counts in sterile injectable (SI) development, where timely access to treatment can significantly impact patient outcomes.
Navigating the growing need for sterile injectables
From monoclonal antibody therapies to cytotoxic compounds for oncology treatments, many therapeutics rely on delivery via sterile injection to avoid the harsh conditions of the gastrointestinal tract and first-pass metabolism. Injection also enables rapid delivery to the target via the bloodstream. In recent years, the pharmaceutical industry has seen a rising demand for SI therapeutics, driven by these advantages and a number of key trends.
Along with a rise in chronic conditions that rely on SI treatments, including cancer, diabetes, and cardiovascular diseases, the development and use of biologics and biosimilars, often administered via injection, are expanding rapidly. The growing need for SIs is reflected in the expanding global SI contract manufacturing market, projected to grow at a compound annual growth rate (CAGR) of 12.28% from 2025 to 2030, reaching an estimated value of USD 31.9 billion by 2030.
The need for a lightspeed approach
Developers and manufacturers are not only under pressure to meet the rising demand for SIs but to achieve this at speed. This urgency stems from the need to quickly deliver these vital therapies to patients, minimising the impact of diseases while also meeting investor expectations for a return on investment.
In the face of the rising need to accelerate SI production, developers and manufacturers can leverage lessons learned from previous high-pressure scenarios demanding a rapid response, such as pandemics, natural disasters, drug shortages and geopolitical events. The COVID-19 pandemic serves as a prime example of the challenges the pharma industry can face when striving to deliver SIs to patients quickly, including supply chain disruptions, raw material shortages, capacity constraints and the need to swiftly adapt manufacturing processes to meet unprecedented demand.
Under high-pressure situations, adopting a "lightspeed" approach is critical to navigating challenges and delivering therapies to patients quickly. This involves streamlining processes, fostering collaboration across different teams and making rapid decisions to accelerate development and production without compromising quality or safety.
Developers and manufacturers leveraging a lightspeed approach will apply the following steps:
1. Finding creative ways to shorten timelines
SI developers and manufacturers must meticulously analyse each stage of the project, identifying critical decision points and opportunities for optimisation. By understanding the dependencies and potential bottlenecks, they can make informed decisions to streamline processes and accelerate progress. Developers and manufacturers can also significantly expedite timelines by embracing parallel processing, where multiple development activities are conducted simultaneously rather than sequentially.
2. Promoting a collaborative approach
Achieving lightspeed development relies on cultivating a collaborative and agile environment. This involves fostering an "all hands on deck" attitude, assembling a large and diverse team of experts and maintaining frequent communication to address challenges and explore innovative solutions. A cross-functional core team comprising members from various disciplines should be established to align on parallel activities and ensure efficient coordination.
3. Leveraging technology to accelerate data exchange
Secure, readily accessible platforms, such as shared online workspaces, facilitate real-time communication, data sharing and decision-making between all teams involved in SI development. By leveraging the right digital technologies, developers can swiftly respond to challenges and foster a more agile and responsive development process. Specialised technologies like automated fill lines integrated with digitised technology can also help to accelerate timelines in high-pressure situations while enhancing data integrity, safeguarding sterility and helping to ensure product safety.
4. Clearly defining designated decision-makers and points of contact
Establishing clear roles and responsibilities is critical for efficient decision-making and streamlined communication in lightspeed development. Designating a primary point of contact and empowering decision-makers can help cut through bureaucratic hurdles and ensure swift action. Effective communication between project management leaders and business unit leads is needed to maintain alignment and keep the project on track. Additionally, a joint steering committee can facilitate rapid decision-making on critical path items and overall timelines, ensuring the project progresses efficiently and effectively.
5. Mitigating the potential for disruptions and shortages
By understanding the potential stressors a drug product will endure throughout its lifecycle, from early development to commercial manufacturing, developers and manufacturers can identify and address potential risks that could impact timelines. This involves carefully evaluating potential disruptions and shortages, and asking critical questions such as:
- Can manufacturing complexity be reduced?
- What are the unique needs and vulnerabilities of this specific product?
- Can supplier interactions be streamlined?
- Are there multiple suppliers for critical materials to avoid shortages?
By proactively addressing these factors, developers and manufacturers can minimise the risk of delays and disruptions, ensuring the timely delivery of critical therapies to patients.
Relying on a CDMO with experience in lightspeed development
In the face of increasing pressure to accelerate SI development, partnering with a contract development and manufacturing organisation (CDMO) that has successfully navigated high-pressure situations, such as pandemics or drug shortages, can be a strategic advantage. These CDMOs possess valuable experience streamlining processes, optimising resources and making critical decisions rapidly without compromising quality or compliance.
By applying the lessons learned from these experiences, these CDMOs can effectively support their partners in meeting the rising demand for speed, ensuring that life-saving therapies reach patients quickly and efficiently, even in the absence of high-pressure events. These strategies will include:
- Capacity planning: Leveraging network strategy groups to maintain an overview of reserved capacity allocations to help ensure resources are available when needed.
- High-speed lines: Providing dedicated high-speed lines for projects with accelerated timelines.
- Batch size optimisation: Increasing batch sizes where possible to maximise production efficiency.
- Equipment optimisation: Optimising the use of existing equipment and implementing flexible manufacturing approaches.
- Product line combination: Combining several products on the same filling line, utilising dedicated product paths to maintain segregation and prevent cross-contamination.
These CDMOs also possess the regulatory expertise and quality systems to ensure compliance and instil confidence in meeting regulatory guidance. Additionally, they can help identify and address potential supply chain risks, such as the need for alternate sources of raw materials or container types, ensuring a smooth and uninterrupted path to commercialisation.
Preparing to meet the SI needs of the future
The growing demand for SI products presents a significant challenge for the future of the pharmaceutical industry. To meet these growing needs, drug developers and manufacturers must adopt strategies prioritising both speed and quality.
Partnering with a CDMO with a proven track record of success in lightspeed development can offer a strategic advantage. These CDMOs bring valuable experience in streamlining processes, optimising resources and making critical decisions rapidly, all while maintaining a steadfast commitment to quality and compliance. By applying the lessons learned from navigating high-pressure situations, they can effectively support their partners in meeting the evolving demands of the SI market, helping to ensure patients have timely access to the life-saving therapies they need.