Selecting the Right-Fit Partner for Biotherapeutic Development

Finding a right-fit partner for biologics drug development has become increasingly important, especially as hundreds of new biotherapeutics—cell therapies, gene therapies, bispecific antibodies, antibody drug conjugates (ADCs), vaccines, etc.—move through a burgeoning biologics pipeline. But what criteria, skills, experience make for a good manufacturing partner? Just as important, what is the evaluation process by which potential partners are screened?

Drug developer seeking partner

To start with, what are biologic drug developers looking for in a contract development and manufacturing organization (CDMO) or a contract manufacturing organization (CMO), or other service provider? Jean-Christophe Hyvert, chief commercial officer at Lonza, notes that Lonza, for example, is positioned to work with many biotech companies of various sizes. He points out that emerging and small biotech companies make up approximately 80% of the total drug development pipeline today and are a key segment for CDMO companies. About 50% of Lonza’s partners, for example, are represented by emerging, small biotech companies and virtual companies.

“This particular biopharma segment is looking for a CDMO that can address their specific needs; not only free capacity but also critically importantly: experience with fulfilling regulatory requirements, procurement power, legal frameworks, and speed, without added risk. These small companies also require a well-established partnership offering and flexible funding milestones that add value at every development stage,” Hyvert states.

For biologic drug developers partnering with a CDMO or CMO, it is critical that the CDMO/CMO provide services that meet developers’ needs as well as have the capacity to manufacture the desired pipeline, says a company official at Samsung Biologics. With rising biologics demand, the Samsung official says, the company is seeing drug developers’ in-house capability hitting a limit, ultimately resulting in them outsourcing services to meet these demands.

When choosing the right outsourcing partner, biologic drug developers look for well-trained employees, well maintained facilities, and trustworthy communication with quality and data integrity, the Samsung official says.

A look at vaccine fill/finish

Amid the ongoing work to bring new biotherapeutics to market is the added challenge of bringing new vaccines to market to combat the global COVID-19 pandemic. “The global pandemic has created supply constraints and long lead times for many products used in the biopharma sector; everything from gloves and other PPE [personal protective equipment] to resins and single-use disposals as well as primary packaging components have been impacted,” says Randy J. Maddux, chief operating officer, iBio.

Maddux points out that the pandemic also emphasized the gaps that exist in available fill/finish capacity. “And, as a result, we’ve seen a number of players make investments to bring more capacity on-line. That said, indications so far are that the biopharma sector has done a good job in planning for aseptic fill/finish of the new vaccines and reallocating and reprioritizing capacity where needed to meet current demand,” he says. He also cautions that the situation could easily change as the rate of vaccine administration ramps up and/or further disruptions in the supply of fill/finish components occur.

“For us, there was no big difference before and after the pandemic in regards to the technological aspect of the fill/finish process,” interjects the Samsung Biologics official. The most challenging aspect came from the supply of primary packaging materials, the official notes. Even before the pandemic, the utilization rate of CDMO companies continued to increase to meet ongoing biologics demand and supply balancing, but the COVID-19 pandemic added unanticipated demand in a very short period of time.

Hanns-Christian Mahler, head drug product services, Lonza, adds that sterile fill/finish facilities are also not available in abundance, and the capacity of existing sterile facilities is often quite well utilized. One should also not forget that there are also many other medicines to be supplied, not only COVID-19 vaccines, he emphasizes. “Hence, there is, from my perspective, still a significant need to have more sterile manufacturing capacity globally.”

Technical expertise

Mahler observes that there are many factors to consider for long-term manufacturing supply agreements for a biotherapeutic project. The first key question that a biologic drug developer and prospective manufacturing partner may need to ask is whether the available sterile facility is suitable from a technical perspective:

• Is the equipment that is required available and implemented?
• Is the facility able to handle the drug (e.g., from any environmental, health, and safety perspectives?)
• Does the facility have the relevant quality certifications?
• Is there sufficient capacity available, or can it be made available in due course to meet the supply-demand?
• In addition, are there sufficient experts available, or can they be hired in due course?

“Apart from these factors, regulatory expertise is becoming of crucial importance, especially in the context of the novel and/or accelerated pathways. As the diverse biopharma landscape changes, the methods we use for developing and manufacturing drugs, increasing control, and streamlining operations through automation become necessary in the future of manufacturing,” adds Hyvert.

Furthermore, service providers need to constantly monitor industry trends and be in tune with clients’ needs, developing technologies, and digitalized solutions, says the Samsung Biologics official. “Process intensification technologies, such as N-1 perfusion and non-stop centrifugation, are reflective of latest industry trends, and implementing these would make a CDMO an attractive partner,” the official states.

Industry advice

In terms of industry advice that can help maintain a long-term partnership between contract manufacturing service providers and drug developers, data integrity and transparency should be the top priority, says the Samsung Biologics official. “It is critical that a service provider maintain close communication with clients to achieve this. For example, Samsung Biologics provides real-time remote client access to our quality document viewing and approval system, allowing for faster release of product batches, and agile response in case any issues occur,” the official states.

Maddux concurs that frequent, open communication and a spirit of collaboration and teamwork are keys to any successful long-term partnership. “This takes the form of establishing trust between key stakeholders, often to the point where there is a personal relationship of mutual respect. Establishing a well-written MSA [master services agreement] that contemplates likely challenges and things that may go awry is important, but it is virtually impossible to cover every situation.The ability to work together in the gray areas between the black and white as written into the contract is the ‘gold standard’ for successful long-term partnerships,” he states.

New challenges have brought on accelerated approval pathways such as fast track and priority review, adds Hyvert. “We are witnessing an increased pressure to quickly deliver therapies for the patients who need them the most, which puts pressure on process development and manufacturing capacity. The COVID-19 pandemic has increased the emphasis on speed to market, disrupting supply chains, the supply of raw materials, and access to quality capacity, which causes delays in clinical trials,” he says.

“Forming a strong partnership is definitely the key to creating a transparent and open relationship based on trust and flexibility to solve customer issues, such as changes in capacity and timelines as well as technical challenges,” Hyvert adds.

About the author

Feliza Mirasol is the science editor for Pharmaceutical Technology

Article Details

Pharmaceutical Technology
Supplement: Partnering for Bio/Pharma Success
February 2021
Pages: s10–s11

Citation

When referring to this article, please cite it as F. Mirasol, “Selecting the Right-Fit Partner for Biotherapeutic Development,” Pharmaceutical Technology’s Partnering for Bio/Pharma Success Supplement (February 2021).