While venture capital funding has seen some corrections post-pandemic, investment in emerging biotechs—particularly those focused on cell and gene therapies, or platform innovations—remains strong(1). For these companies, making strategic decisions about process development early on is crucial for long-term success. This ongoing investment will likely result in continued interest in outsourcing process development. Sometimes, these types of collaborations are necessary to fill the resource and expertise gaps within companies. Other times, it’s best to keep production in-house. How do companies choose? In this article, we discuss five key considerations for deciding between in-house or outsourced process development—and offer guidance on making the right choice.
Why keep your process development in house?
For some companies, outsourcing process development (PD) workflows makes sense. Often, companies choose a contract manufacturing and development organization (CDMO) that can offer a specific range of services and capabilities—whether upstream or downstream development, scale-up, or tech transfer to GMP-readiness. However, there are benefits to keeping PD in-house. If the company has full process expertise and the neccessary equipment, then it is easier to pursue process development in-house as there is no need for legal to be involved to review contracts. Driving process development within the company helps companies save time and resources. Importantly, the biopharma or biotech company is able to keep full process ownership, which they will likely lose with a traditional CDMO. However, if they lack equipment to fulfill the complete workflow, have limited capital expenditures, or do not have some part of the expertise, then keeping PD in-house presents more risk as the drug development process could take more time or may not return optimal results.
Why outsource process development?
Outsourcing bioprocess development brings many benefits. This includes the opportunity and potential to expedite the bioprocess development timeline, enabling companies to enter pre-clinical studies faster and to enroll their drug in clinical trials in a time-efficient manner. Partnering with single-use and automation suppliers, and biopharma and biotech organizations, will reduce the risk of failing in the late clinical phase. Benefits of outsourcing include:
- Expertise: CDMOs have the necessary expertise for scalable, well characterized processes. Well optimized and scalable processes are key to helping ensure regulatory compliance, lower cost of goods sold (COGS), and quality of product.
- Flexibility: having a clinical pipeline with several platforms and scales. When a company doesn’t have in-house capability for processing certain cell lines or platforms, outsourcing becomes a viable option to take the drug molecule to the clinic.
- Lower COGS: Increasing pressure for return on investment and lower COGS pushes companies to rationalize and limit their resources in-house.
- Risk mitigation and strategic partnerships
How to choose the right outsourced process development provider
Regardless of whether you are just entering the field or simply responding to the influx of competition, you must know how to vet potential providers, especially for process development services. This critical step is a key factor in determining your drug program’s overall success. A panel of experts with experienced and diverse perspectives discussed this topic during an online event titled Best Practices for Outsourcing Process Development, where several themes surfaced that may help drive the best outcomes with your process development service provider.
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Determine your process development needs.
Before selecting a CDMO for your outsourced process development needs, first and what outcomes you expect to achieve. Your current product life cycle phase may help you determine your needs. If you are in Phase I, the process has not been locked in yet, so there is still room for process development optimization. Conversely, if you are already in Phase III, any process changes would be hard to implement due to compatibility studies and other regulatory hurdles.
Determining your process development needs also depends on your existing resources, such as in-house expertise and capacity. However, don’t let “perfect” get in the way of “good enough.” Ask yourself, does my current process provide sufficient quantity and quality of product in the time required at the given scale and capacity? This requires an understanding of the quantity of products required at each phase of the process, which will increase as you progress. This exercise would also factor in scale, batch size, and run capacity with respect to time. The definition of success can change over time, especially as you move through each clinical phase, so avoid getting tied down by a certain outcome if you have already achieved the quantity and quality of product required at the scale and capacity needed.
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Look for providers with experience and flexibility.
By the time a biopharma collaborates with a CDMO, they probably already have a process development and technology roadmap that outlines the most appropriate tools for the project’s needs. Therefore, the best process development organizations are those that are most flexible when it comes to technology. This is because, in most cases, companies don’t approach a CDMO expecting them to manage the entire process from scratch. By the time a CDMO is engaged, significant process development has already taken place—often within academic labs where the molecule originated. As a result, the company usually has a clear understanding of how the process should be run. Partnering with a CDMO that is locked into a specific technology and dictates how your product should be made may not align with your goals.
However, for early-stage biotechs, they are still optimizing their processes. In such cases, the CDMO’s technical guidance can be a valuable asset, provided it aligns with the long-term goals. As the industry saying goes, “the process is the product”—making it essential to retain control over process decisions. In addition, you must ensure the CDMO has the equipment that you need for your process to facilitate technology transfer (along with documentation, process details, successful and failed data, as well as all other relevant information). One-stop-shop CDMOs tout expertise in all areas of development and manufacturing; do your due diligence to ensure they can walk the talk. While some CDMOs may be able to do it all, it may be necessary to bring certain steps to more qualified providers.
Overall, experience and adaptability are two significant characteristics to have in a CDMO. The industry has many established molecules and processes, but it also has various emerging technologies. Understanding how to expedite the development or manufacturing of any of the diverse spectrum of molecules—and the flexibility to do it—is critical. Platform processes can help in this effort, but speed, quality, and reliable resources will always be fundamental characteristics for a CDMO. Also, look for a provider that has a successful outsourcing history. With a ripening market for CDMOs, some drug manufacturers with underutilized infrastructure and expertise are offering their own resources and capacity. Although this could be beneficial in certain situations, working with a CDMO that knows how to be a CDMO is likely going to be the best path forward.
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Set safeguards to manage supply of critical raw materials.
Whether you rely on a CDMO or your own process development and/or manufacturing capabilities, advanced planning, an adequate general inventory both on and off-site, and an inventory of the materials with the longest lead time are all vital safeguards for combating global supply chain issues. This should include not only raw materials and consumables but also other supplies and items that can sometimes be taken for granted, such as pipettes, gowning, and gloves. Platform processes can also allow early design-in of critical raw materials and, therefore, enable a consistent inventory or placement of orders for these materials far in advance.
It’s also important to confirm if your CDMO has control over or ownership of the supply chain that produces the supplies, raw materials, or consumables needed for process development and manufacturing. For example, imagine you have multiple vendors funneling into the supply chain for your GMP materials. One of these suppliers should, in theory, be able to back integrate into the starting materials that you need. If there is a fundamental global supply disruption, the CDMO retains the ability to manufacture and supply the critical raw materials that you will need to further process your material to meet your goals. This upfront planning can occur without any change in expenses or timing.
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Focus on quality from the start.
Effective quality management is, of course, a primary focus and essential function throughout the drug development and manufacturing life cycle. Therefore, it only makes sense that careful scrutiny of a CDMO’s quality department and its processes sits high on the list of considerations. This can begin as early as the request for proposal (RFP) process. Often, the CDMO designs the RFP template that the sponsor uses to provide their project’s requirements and expectations. Although the information requested is important, it is biased toward their needs. Instead, design your own template that outlines the information necessary to help you vet quality from the start.
For example, if the CDMO is going to be progressing into the GMP or compliance parts of a project, information about their interactions with regulators, history of success (or failures), and even audits should be included in the template. Make sure they share raw data about project campaigns, batch history, and audit findings, and be specific about what details you want. It is also important to find out their ratio of quality to manufacturing personnel. Ideally, the ratio should sit somewhere around one quality person for every five in manufacturing. If there is an overwhelming number of people in manufacturing and only a couple in quality, then you will want to inquire about the turnaround time for batch release and batch release data once production is finished, as this ratio could indicate potential delays.
The right RFP template can also help streamline the work that goes into getting a project started, reducing the wait time to get up and running. Indicating early on that you want to negotiate master service and quality agreements, as well as requesting specifics about communication channels, can facilitate later steps such as documentation review cycles by the respective legal and management teams. The faster all of this is completed, the sooner you can move on to readying key components of your project such as raw materials and consumables.
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Consider your long-term intellectual property and tech transfer strategy.
Early-stage biotech companies may initially depend on CDMOs to accelerate early development, but it’s important to build internal capability or plan for knowledge transfer down the line—especially if you anticipate moving to internal manufacturing or licensing. Retaining control over key aspects of the process helps ensure flexibility as your company scales.
While these considerations cover some of the most critical areas in the path to market—quality, supply, and expertise—there are many factors you must consider when finding the right CDMO for your process development needs. Designing a plan of action on how to vet your future CDMO is an early but vital step toward securing a collaboration that lasts the entire product life cycle.
The last several years have brought important lessons to our industry and will continue to do so. Stakeholders across the biotech and biopharmaceutical industry today have a greater responsibility to ensure the choices we make continue to advance our cause.
Whether you're an emerging biotech looking to bring your first molecule to clinic, or an established company scaling up for late-stage trials, Cytiva Fast Trak™ process development services (PDS) can help bridge your resource gaps and accelerate your path to market.
About Cytiva process development services
Our Fast Trak™ process development services help biotech companies accelerate their molecules through clinical development. With global reach and deep scientific expertise, we offer solutions and delivery technologies across diverse modalities. These include recombinant proteins, mAbs, viral vectors, plasmid DNA, mRNA, and lipid nanoparticles. Our experienced scientists will work closely with you to set goals and manage your projects of any size with full transparency. We will support your molecule’s manufacturability, upskill your team with training and education, and transfer all process knowledge to you—until we cross the finish line together. Think of us as an extension of your team.
Learn more about Fast Trak™ process development services.
REFERENCES
- McKinsey & Company. What early-stage investing reveals about biotech innovation. McKinsey. https://www.mckinsey.com/industries/life-sciences/our-insights/what-early-stage-investing-reveals-about-biotech-innovation. Published December 12, 2023. Accessed May 14, 2025.