Fill-Finish Development Challenges & Solutions for CDMOs

Recently, contract development and manufacturing organizations (CDMOs) involved in the pharmaceutical industry have seen massive growth as demand for their services has increased sharply with demand for various pharmaceutical products continuing to grow. Lab Manager recently connected with Katie Schlipp, VP of laboratory operations in Wilmington, NC, at Alcami Corporation, to discuss how she is helping to manage this increase in business while ensuring her staff is looked after.

Q: With the large increase in demand from pharmaceutical companies for your services, what are your biggest challenges?  

A: Alcami is investing in its biologic capabilities and continued laboratory expansions to meet the significant demand for biologic, formulation, and fill-finish manufacturing services. Five fill-finish manufacturing lines are being added, along with a doubling of the laboratory space in our Research Triangle Park, North Carolina, laboratories with new state-of-the-art equipment and instrumentation to support the expected growth. The expansion of our laboratory and manufacturing space is expected to be more than 110,000 sq ft over the next year. With more than 40 years in the pharmaceutical development industry, Alcami has solid processes and procedures with an excellent reputation in regulatory compliance to support programs from early phase preclinical to commercial. Currently, about 50 percent of our business is supporting commercial manufacturing and testing. We partner with a diverse client base, from emerging biotechs to global pharmaceutical companies. As the industry expands to targeted therapies, we do expect significant growth within our biologics service offerings.

Q: How are you handling those challenges? 

A: Building a scalable business requires a continual assessment of structure, resources, systems, space, capabilities, capacities, and technologies. One key is having the technical depth and the ability to meet tight timelines, along with the expertise to scale in a complex environment. We are keenly focused on building a strong team of experts that are experienced in scaling the business and ensuring client-centered leadership. Scaling the business simply means that we are equipped and ready to successfully handle a substantial increase in business and are able to onboard new programs without any adverse impact to performance. Our management team meets regularly to strategically assess what is hot in the industry or what new business is coming to ensure we are operating ahead of the business need. 

As we assess opportunities to improve efficiencies, we go to the experts: our team. On the frontlines, they are performing the work, using the equipment and analytical systems, and pushing through the analytical and quality workflows to provide the best perspectives on how we can combat complexity and waste. Our leaders meet regularly with the team on the frontline to help uncover any opportunity for improvement. The opportunities translate to action, whether it be “Lean Lab” organization or simplifying a process to remove idle or waste time. Some examples would be minimizing walk time and creating a space that provides all the supplies you would need within a few steps, or removing redundancies in SOPs, systems, and workflows. These efficiencies translate to savings for our customers.

It is our aim to make every process as simple as possible while maintaining the highest standard of compliance. With the growing industry and regulatory expectations in laboratory controls and data integrity, it is critical that we assess our procedures on a continual basis to eliminate any waste that may create bottlenecks or inefficiencies. For example, computer software validation (CSV) is a tightened control within the industry and can be a bottleneck. To reduce complexity and avoid bottlenecks, we have standardized and streamlined the CSV portion for equipment onboarding and we take every opportunity to harmonize equipment types across all sites to reduce the CSV activities and to reduce the number of system types/software that is onboarded.

Q: Which stages of the drug discovery/development/production process are most challenging? Why? 

A: In the laboratory operations, analytical method familiarization or method establishment is typically the most challenging stage, especially since these methods accompany a drug product for as long as that product is sold, which can be decades. Our clients expect to establish simple analytical methods where testing can be performed by any trained analytical chemist. We are focused on developing and establishing QC-friendly methods to ensure they are highly robust for release and stability testing. We employ high throughput instrumentation that can efficiently screen solvents and columns to reduce the method development time while ensuring robustness of the final parameters.

Q: What are some ways you’ve helped your lab and staff to be more productive and handle the workload without getting too stressed? 

A: There are many things that we do to help reduce the pain points that could cause stress. For example, ensuring we have a proper onboarding process and training program is key to help minimize stress. We also have routine one-on-one discussions to listen and understand workloads and obstacles to determine where adjustments are needed. Additionally, we encourage an owner’s mindset. Where the team sees an opportunity, we want them to voice it and act on it to make the processes more efficient for everyone. We encourage the “smarter, not harder” philosophy and we reward those with ideas that bring value to the organization. Another aspect that reduces stress is the strong sense of community and team we’ve built. You will see many examples like motivating huddles, backyard barbeques, dinner celebrations, and even community outreach programs. These events help the team stay connected with a strong sense of value and belonging.

Q: How do you expect things to change going forward? Will the workload continue to increase? 

A: We expect significant growth in biologics over the next several years. We will be adding 11,000 square feet of lab space that will support biologics manufactured within our network or as a standalone service. With this addition, our biologics lab and capabilities will more than double in size in the coming months.

Author: RACHEL MUENZ

Rachel Muenz, senior digital content editor for Lab Manager, can be reached at rachelm@labmanager.com.