In-House Production vs. CDMO Cell Therapy Development Considerations | Corning

Cell therapies are complex treatments with sophisticated requirements for biopharmaceutical process development and manufacturing. Accordingly, laboratories working on cell therapies need to weigh the benefits of in-house production against the benefits of working with a contract development and manufacturing organization, or CDMO.

In-House vs. CDMO Cell Therapy Development Considerations

Cell therapy products are often developed by startups or academic labs that have a narrow pipeline consisting of one or a few products. Many gene and cell therapies under development today need to be custom produced using the patient's cells, and some require separate culture systems for producing viral vectors and for modifying patient-derived or allogenic cells. These factors present unique manufacturing challenges.

Labs weighing whether to pursue in-house production or tap a CDMO have a lot to consider. Here's a look at the advantages and disadvantages that in-house production vs. CDMO cell therapy collaborations offer and some of the factors that can move the needle in either direction.

Related Technology

In cell therapies, small changes in the culture system or process steps can have a big impact, potentially altering cell growth or characteristics. Your lab should plan ahead so that going from pilot scale experiments to production scale, or from preclinical to clinical stages, doesn't require disruptive transitions.

CDMOs offer both process development and manufacturing assistance. Working with an experienced CDMO can allow you to benefit from expensive, specialized equipment and clean room space. If an on-site clean room isn't available, open process steps that require clean rooms can tilt the deck toward working with a CDMO. However, closed culturing systems or automated systems that minimize manual steps may simplify the requirements and make in-house development possible.

Starting with a compatible platform can allow for smooth scale-up to happen in-house. For example, modular and flexible technologies now on the market can help you increase production volumes while maintaining stable conditions for cells.

Resource Planning

Planning ahead is important throughout the development process, including when choosing a manufacturing platform.

Developing in-house capabilities requires planning ahead for talent, space, equipment, and supply needs. Manufacturing space can be difficult to secure, and it takes time to hire and train employees with the right skill sets. To avoid problems related to supply chains, check with equipment and supply vendors well in advance if you're planning to expand your space or if you anticipate a significant scale-up in production volume.

Likewise, finding a CDMO that's the right fit for your project takes time. Wait times for appropriate CDMO space can be 12 to 18 months in the fast-growing field of cell and gene therapies. You'll also need to consider onboarding time and the work that both sides will need to put in to develop a good working relationship. Be sure to discuss how intellectual property will be handled to ensure the CDMO can meet your company's needs.


In-house manufacturing can allow for greater flexibility because the entire process is in your experts' hands. When you need to move quickly, having everything on-site may enable you to make more agile changes to your product and process. Developing in-house capabilities and expertise can increase future flexibility in developing your lab's next product or the next generation of a current product.

However, when working with a CDMO, setting up excellent communication and teamwork processes upfront can increase flexibility and reduce delays down the line.

Many companies perform some steps of their biopharmaceutical process development and manufacturing in-house while also working with a CDMO to optimize flexibility on their path to market. This can give you the best of both worlds in terms of flexibility — but only with careful planning and communication.

Technical Expertise

In the complex field of cell therapies, technical expertise is key. Companies can broaden their technical expertise by working with a CDMO, by hiring and training employees with a strong history in the field, and/or by bringing in outside technical experts (such as experts at supplier companies or consultants) to help with in-house setup. Depending on your product's specific characteristics and your future product development plans, certain areas of expertise may be important to develop in-house.

Regulatory and GMP Requirements

Being ready to meet regulatory and good manufacturing practice (GMP) requirements is another critical factor. You need to decide whether it's more feasible to hire people with strong expertise in GMP and regulatory requirements or to work with outside experts, such as employees at a CDMO that already has a regulatory track record.


Cost considerations are also important in bringing cell therapies to patients who need them. If you have a small lab, you may find that working with a CDMO is more cost-efficient, at least for certain steps, rather than developing your own full facilities. On the other hand, investing in automation and flexible or modular setups may help you drive down in-house costs for these complex therapies. You'll need to investigate these issues in light of the specific characteristics of your company and product.

Cell Therapy Expertise at Corning

Corning offers flexible platforms for cell therapy development and scale-up, including modular, closed-cell growth systems and smart, scalable bioreactors with built-in sensors. Visit the website to explore recently released products and resources. Or, get in touch with an expert to learn more.