Challenges and Solutions for Pharma CDMOs Hero Image

Challenges and Solutions for Pharma CDMOs

How CDMOs address the recent increase in demand for their services and meet client needs

Rachel Muenz

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 Anish Parikh, VP of sales and marketing, drug products, at Curia Global, Inc. and Katie Schlipp, VP of laboratory operations in Wilmington, NC, at Alcami Corporation, to discuss how they are helping to manage this increase in business while ensuring their staff are looked after.

Anish Parikh, VP sales and marketing, drug products, Curia Global, Inc.

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

A: The two main challenges can be summarized as supplies and speed. Demand for critical supplies remains high from manufacturing, health care, and other essential businesses and nations continue to ramp up stockpiling measures. For CDMOs, the pandemic levels of activity continue. Disruption sets a new bar and becomes the norm. Now, even simple components such as syringes, vials, and stoppers have four- to six-month lead times. Certain essential medicines used in the treatment of COVID-19 patients have also experienced shortages due to insufficient production capacity and the need to divert the primary components toward COVID-19 products to address the pandemic. PPE remains an acute need for manufacturers as workforces have expanded and facilities are running 24/7.

At the same time, we have to move at extraordinary speed and the needs change quickly, demanding extreme agility. From one week to the next, the landscape changes and you have to respond quickly, moving at pandemic speed.

Q: How are you handling those challenges?

A: The CDMO industry was growing at a compound annual growth rate of seven percent prior to COVID and we’ve seen demand increasing. Prior to the COVID pandemic, the industry’s capacity to make injectable drug products like vaccines was already constrained. COVID just exacerbated the problem.

The global market for CDMO injectables in 2019 was $9.4 billion and is expected to be about a $15 billion market by 2024.

We’re handling challenges by investing organically and in acquisitions. For example, Curia recently announced a definitive agreement to acquire Integrity Bio, a formulation and fill-finish company.  Aside from its fill-finish capabilities, Integrity is known for its expertise in “hard-to-formulate” biologics like proteins, antibodies, lipid nanoparticles, peptides, and vaccines in both liquid and powdered forms.

“At the end of the day, it’s about supporting patients.”

Organically, we are expanding capacity by building or investing in our existing space.   

In an effort to assure our ability to meet the production needs of our clients, we plan significant inventory of vials and syringes and other components. We do this to meet our manufacturing capacity commitments to our pharmaceutical customers.

We monitor our contracts to maintain current terms, and we have contingency plans with all parties involved—including our suppliers—to confirm a steady supply of product and understand the lead times, so we can get what we need on short notice if necessary. 

In many cases, we also recommend to our clients that they have back-up suppliers, so that if they have a life-saving drug and Curia doesn’t have the immediate capacity to make it, they can leverage a second supplier. At the end of the day, it’s about supporting patients.

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 two approaches. Culturally, we are focused on engagement, planning cookouts and offering summer hours where possible. We arrange to bring clients on site where they present impact stories, helping our employees understand how we help patients get their medicines. For example, an executive of one of our clients, which makes a product for a rare pediatric genetic syndrome, presented to our team. The executive’s child lives with this syndrome, so she helped our employees understand the real-life impact of this disorder. It was really compelling and motivating to learn firsthand about the impact of our daily work. 

Operationally, we constantly re-evaluate our processes and look for ways to improve. Each of our sites has an operational excellence person responsible for streamlining processes and alleviating stress and workloads on our employees. If a process takes 10 hours, we look at ways to get it down to eight or even six hours. 

At the same time, we’re also hiring people and investing in our employees. We introduced an innovative approach to training people to work in our “right-first-time” approach to operations. “Sterile University” is our name for a program that trains employees to work in a sterile cleanroom environment. Since a significant portion of our products are made in sterile manufacturing facilities, we train employees on a simulated sterile line to prepare them to work on a true sterile manufacturing line. We also include clients or regulatory agencies if they want to review it or even attend courses.

With the growth in the CDMO industry, the demand for talent is extraordinary. Through Learning Initiatives for Employees (LIFE), we offer career and leadership training for those who are looking for growth opportunities. We use engagement surveys to prioritize what makes a difference for our employees as a way to help retain them and learn what more we can do to make Curia a great place to work. We made the Forbes list of America’s Best Employers for 2021 and we’re always looking for ways to improve.

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

A: The biopharma industry will continue to outsource more and more, and CDMOs will have to offer expertise and build capacity to meet demand. There are now many biologic drug products in clinical trials, so we are going to see an increasing number of drug approvals for injectables.

Katie Schlipp, VP of laboratory operations, Alcami Corporation.

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.

“Another aspect that reduces stress is the strong sense of community and team we’ve built.”

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.