Unveiling the Power of Experience: The Key to Next-Level CDMO Services
Contract Pharma editor Tim Wright unveils the power of experience in CDMO services during his talk with Amanda Hawkins, Grand River Aseptic Manufacturing’s director of manufacturing. Learn why experience is key for next-level CDMO services.
How does Grand River Aseptic Manufacturing (GRAM) ensure that new filling lines quickly transition from being “just shiny stainless steel” to fully operational assets? How is your experience a key differentiator from the competition?
Grand River Aseptic Manufacturing (GRAM) ensures that new filling lines transition swiftly from being just shiny stainless steel to fully operational assets through efficient processes and comprehensive training programs. Our involvement in two public health emergencies over the last four years has driven our teams to advance the commissioning and validation of new equipment to meet demands. We have learned a lot in a short time and have been able to apply what we have learned as we have expanded and onboarded new clients and processes.
After our first filling line and the rate at which its capacity was filled, GRAM strategically invested in two more Bausch + Ströbel filling lines with SKAN isolators. Having the same platform technology across our filling equipment (now at four filling lines) makes onboarding new projects and processes smoother for our team because they were already trained on similar equipment and technology.
GRAM has consistently operated at high production levels over the past four years through our role in two public health emergencies. The GRAM team gained extensive experience in manufacturing safe and effective products as we produced over 30 million units and tech transferred over 20 new products. Our experience is reflected in our growth, our robust training, and the variety of clients and products we serve.
What strategies does your team employ to maintain high levels of production across multiple shifts? How do you ensure that all operators are adequately trained and prepared for the complexities of aseptic manufacturing?
Our team employs several strategies to maintain high levels of production across multiple shifts. Firstly, we have streamlined protocols to suit our equipment and facilities quickly, allowing for efficient transitions between shifts. We have implemented comprehensive checklists that go beyond standard protocol, ensuring that every event is captured and that a responsible person is identified for each event. This approach guarantees that we have accounted for every step in the production process.
In addition, we have introduced new processes and established a robust training program for current and new staff. Our training programs start at the aseptic operator level and are designed to ensure that all operators are adequately prepared for the complexities of aseptic manufacturing. We also sustain staff for multiple shifts of aseptic operators, enabling us to provide hands-on training as we progress. This involves having dedicated training staff assigned to each shift of operation, as well as a training lead who oversees their performance to allow continuous improvement of training practices and tools. This multi-faceted approach enables us to maintain high production levels and ensures that all operators are well-prepared for their roles in aseptic manufacturing.
Achieving zero hits over an extended period during media fills is a significant achievement. What steps has GRAM taken to consistently achieve this level of performance? How do you prepare for potential challenges during this process?
At GRAM, we have taken several key steps to consistently achieve the high-performance level we maintain. First and foremost, we have implemented isolators across all our lines to set our team up for success, employing engineering controls to mitigate human error. Second, we ensure that our team is highly qualified, experienced in handling multiple vial, syringe, and stopper configurations, and highly trained in aseptic technique. Finally, we place significant emphasis on maintaining the health of our clean areas to ensure that sterility assurance levels are met and that all necessary elements are in place in the clean rooms. This results from routine internal auditing of the physical spaces and trending of the data obtained from environmental monitoring.
To prepare for potential challenges, we stay attuned to regulatory guidelines and pay close attention to client feedback. This thorough preparation enables us to effectively navigate challenges and maintain our high standards of performance. We deeply value our relationships with our clients, equipment manufacturers, and experts who support the products we are working on. Our strong focus on the patients who will receive the therapeutics we are developing is a driving force behind our team’s commitment to excellence and brings excitement when working on novel therapies.
With the need to handle various vial, syringe, and stopper configurations, how does GRAM stay agile? What is your approach to qualifying and running multiple configurations efficiently?
To stay agile, GRAM focuses on several key approaches. We prioritize implementing versatile change parts that can accommodate varying vial, syringe, and cartridge configurations, enabling us to swiftly adapt to different production requirements. To ensure efficient and effective closure integrity confirmation, we optimize our processes, such as crimp pressure evaluations and CCIT methods, along with applying learning from our machines in terms of component handling. Moreover, we have developed rapid turnaround procedures to identify the most feasible pathways for product release, allowing us to maintain agility in our operations.
Our advanced equipment lets us quickly switch configurations while maintaining high efficiency and precision for dosing and limiting interventions during execution. Additionally, we utilize technology platforms not only for single-use technology but also in our advanced filling lines. This allows us to apply learnings from one line to the others and allows our operators and support staff to easily transition between filling lines, ensuring our processes remain efficient and adaptable from both a human and equipment perspective.
With the evolving Annex 1 landscape, how does your team stay ahead of the curve? What proactive measures do you take to ensure compliance with changing regulations, and how has this impacted your operational strategies?
Our team takes proactive measures to ensure compliance with changing regulations. We regularly engage in comprehensive audits from clients of various sizes and have a thorough understanding of their design and technique expectations. Additionally, we are involved in industry focus groups to keep apprised of the industry standards prior to approval and enforcement. This allows us to continuously challenge ourselves to meet and exceed evolving regulatory standards.
Our operational strategies adjust to incorporate the latest methodologies into our processes. We have established rigorous qualification protocols for container enclosure systems and use analytical analysis to obtain quantitative results. Additionally, we conduct air visualization studies to verify our aseptic processes, which have proven to be highly impactful in ensuring sterility assurance. GRAM’s proactive approach has allowed us to maintain compliance and stay ahead of operational efficiency.
In your view, how does the experience of a CDMO influence its ability to deliver high-quality manufacturing services compared to newer players with less operational history? What key lessons has GRAM learned over the years that continue to set you apart?
A CDMO’s experience significantly impacts its ability to deliver high-quality fill-finish services. An experienced CDMO like GRAM has streamlined processes, deep industry knowledge, and a proven track record of successfully bringing products to market. This level of experience allows us to navigate complex regulatory requirements, anticipate and mitigate risk, and consistently deliver reliable results.
Key lessons that GRAM has learned over the years include the critical importance of collaboration, both internally and with clients, to achieve successful outcomes. We align our efforts with the ultimate goal of helping patients. Our experience has taught us how to collaboratively predict and navigate customer needs and approach decision-making with a focus on the greater good. This knowledge and more continue to set us apart from newer players in the industry and allow us to provide exceptional services.