Outsourcing Cell Therapy Manufacturing
Questions to ask yourself
Cell and Gene therapies include extracting cells or genetic material (DNA) from a patient, altering that material to develop a highly personalized therapy and subsequently injecting it back into the patient. Therapies like these are based on state-of-the-art technology and can require specific, hard-to-find expertise to manufacture. While the entire manufacturing costs are crucial, you also want to ensure a rapid path to market and sufficient flexibility if your plans change.
If you need to produce a Cell or Gene Therapy, there is an ever-growing pool of contract manufacturers offering a range of services and expertise. Due to a scarcity of adequate manufacturing facilities and expert employees, the Cell Therapy sector’s reliance on outsourcing is a constant source of concern.
By outsourcing, you get access to a specialized company’s internal resources, including both its equipment and in-house experts. And, by working with a professional CDMO, you can usually scale up faster.
Here are the questions we recommend asking yourself when deciding if you should outsource your Cell Therapy manufacturing.
Where do you need help?
Outsourcing has become increasingly popular among biopharmaceutical businesses, while others have decided to build in-house production facilities instead. So how did others decide?
It is best to think carefully about what you will outsource. As the need for Cell and Gene development services grows, CDMOs constantly examine and evolve their portfolios and what they can provide to their new Cell Therapy customers. Drug developers are increasingly evaluating the different advantages of outsourcing, including increases in productivity, efficiency gains, quality improvements, and many other aspects that will help them shorten their time-to-market.
Therefore, your analysis should be elaborate and well-thought-out, so you make the right decisions in weighing outsourcing against manufacturing your product in-house. Aspects to consider include:
- Process and analytical development
- Quality Control
- Quality Assurance
- Cleanroom rental
- De-risking capital investment
What is in your pipeline?
A first step toward determining if you want to outsource your Cell Therapy manufacturing is to take a step back and evaluate the number of products in your pipeline. Simply said, that means that smaller biotechs working on a limited number of single Cell Therapy products might be wise to choose a different route than large, established Cell Therapy developers with many candidates in their pipeline.
Additionally, you will have to consider the kind of therapy you are developing. For example, is your product Allogeneic or Autologous? Fresh or frozen? And what about the administration route? Does your product incorporate a medical device? The characteristics that define your therapy cannot be left out of the equation. They represent an important aspect in deciding if you want to outsource your Cell Therapy production and to which CDMO.
Key here is your product classified as an Advanced Therapy Medicinal Product (ATMP)?
Technology: Two-Sided Sword
Although the lack of certain services or technologies could drive Cell Therapy developers towards an in-house manufacturing facility, there is another option. Some CDMOs offer you the option to invest in the required equipment but can be accommodated at the manufacturing site and subsequently used for your therapy.
To no one’s surprise, Cell Therapy manufacturers should offer modern facilities, including state of the art technology. However, technology is a two-sided sword when choosing to insource or outsource your Cell Therapy production.
Making use of existing technology for Cell Therapy manufacturing
The main benefit of outsourcing is that there is no need for a significant upfront capital investment, and you can access expertise immediately, if no queue exists. Although the waiting time to access contract manufacturing services can be significant, the bandwidth and expertise of a Cell Therapy CMO might mean accelerated delivery times instead of building, commissioning and then manufacturing in your facility. In addition, outsourcing also allows you to manage your cash flow more steadily this way.
Adoption of new Cell Therapy Manufacturing technology
You might want to employ novel technologies to ensure a state-of-the-art manufacturing process. Sometimes it is easier and faster to integrate these yourself in-house than expect a CDMO to prioritize adopting new technology. It is a misconception that because of pressure on CDMOs who currently manage the competing demands, they can’t cater to tailored needs for cell therapy production.
If swift adoption of your technologies is essential to your plans, you can choose to do so through in-house capabilities, but you can quickly check whether it’s possible at your CDMO too.
The path in between
Although the lack of certain services or technologies could drive Cell Therapy developers towards an in-house manufacturing facility, there is another option. Some CDMOs offer you the option to invest in the required equipment but can be accommodated at the manufacturing site and subsequently used for your therapy. Or rent cleanrooms?
What are the costs?
Comparing the costs of building in-house capacity versus sourcing capacity externally for the long term is essential. It would be even better to consider multiple scenarios that take success rates for the processes you are developing into account. And in every budget estimation, you should include unexpected expenditures during the project and throughout its lifetime.
If you’re interested in building an in-house facility, these will be major costs to examine:
- Consumable costs
If you plan on outsourcing your cell manufacturing, these are major costs to examine:
- Tech transfer
- Consumable costs.
What kind of expertise do you need?
Core team for your Cell Therapy manufacturing program
Sometimes, onboarding experts might be strategically advantageous, mainly if you are operating in a highly competitive part of the market. It could allow you to build in-house expertise for your core strengths and expand your team from there on if needed; based on the complexity of your product. Some CDMO, like NecstGen, can also assist you in-house and can train your team.
Especially Quality Assurance/Control and GMP manufacturing processionals are essential, and if budget restrictions prevent you from hiring a complete team, consultants might be worthwhile to investigate.
Multidisciplinary Cell Therapy development
Suppose you require various competencies and resources, which is likely in a highly innovative environment such as the Cell and Gene Therapy field. Then, outsourcing is an excellent plan. It allows you to take advantage of your partner’s expertise on short notice, which can be an essential success factor in bringing cell therapies to patients.
Keep in mind that with a CDMO, you’re engaging with an entire organization specialized in manufacturing cell therapies.
Quality in Cell Therapy Manufacturing
Most Cell Therapies are initially developed in academic institutions. While this environment excels at producing new leads for future therapies, the lack of experience with GMP infers a rather substantial challenge for a scale-up. Therefore, it is essential to invest early in manufacturing and supply capabilities, including Quality Lifecycle Management and Quality By Design principles.
You can decrease the notable risks of modifying your manufacturing process in the subsequent development phase by taking these principles into account. The same holds for integrating sound CMC processes early on in your clinical operations. That way, you ensure rapid, uninterrupted product development.
It is clear that not living up GMP-compliant process puts everything at risk, both the stakeholders and the development of your therapy itself. If you cannot gather an in-house team of seasoned (ATMP) quality experts around you, it might be wise to consider contacting a CDMO.
Availability & Capacity
In the longer term, a key consideration is whether a CDMO has the flexibility and capacity to increase (or decrease) manufacturing volumes on demand. So, besides the question, if a CDMO can accommodate your manufacturing at all, limited capacity or flexibility would mean you have to plan and book far in advance.
You need to ensure that your CDMO can adapt to the maximum required volumes, even though that might seem far away from an early-stage perspective.
Of course, it’s not always black and white. For example, as a developer, you can’t always establish a complete set of requirements for an in-house facility if your final scalability needs aren’t precise yet. As a result, many companies go about this decision opportunistic and use outsourcing as an in-between-manufacturing-sites until they fully understand the complete picture.
How do you ensure Tech Transfer?
Your technology will transfer from academics to commercialization from smaller labs to larger facilities along with comprehensive process knowledge to reproduce your Cell Therapy at the required quality and scale and in line with regulatory requirements. Therefore, you should ensure a detailed and robust process description, including critical quality attributes (CQAs) and critical process parameters (CPPs).
If you’re optimistic about keeping manufacturing in-house, there is no need to worry about tech transfer, licensing fees, or concerns about intellectual property rights. Everything is kept in-house.
Keep in mind that, per definition, most Cell Therapy products are highly specialized and require tailored utilities and experienced, well-trained staff. Not all CDMOs are thoroughly prepped for this particular challenge. As mentioned before, a CDMO can experience difficulties accommodating novel technologies resulting in delayed tech transfer. Our recommendation would be to go over entire the tech transfer process with your CDMO candidates to ensure you’re making the right choice if you want to outsource.
Are the operators of the CDMO undertaking the development or manufacturing involved in the tech transfer? This can streamline and improve overall success.
When is the right time to start a conversation?
When would be an excellent time to speak to a possible candidate for outsourcing your Cell Therapy manufacturing? We recommend when you are transitioning from the fundamental to the pre-clinical stage. CDMOs are also used to make preclinical material, and this will likely be a better outcome.
Many Cell Therapy biotechs choose to outsource, as it is crucial for your product development. Although it is best not to rush into commitments, the earlier you start a conversation the better. As long as you thoroughly inventory your needs and analyze potential partners’ capabilities and in-house quality and expertise.
So, to sum up, all the items you should investigate if outsourcing is a good fit for you, you should look into your needs regarding:
- Type of Cell Therapy
- Budget estimations
- Technology requirements
- Regulatory and CMC expertise to upscale
- Quality / GMP expertise to mitigate risk early on
- Availability of established process development
- Flexibility and scalability of manufacturing
- Understanding of technology transfer
Which Cell Therapies are approved?
In these figures, we gathered and visualized overviews of approved ATMPs over the past years for you.
What does the Cell Therapy Development process look like?
From idea to treatment, you’ll face changing requirement and development challenges. View the figure to see how knowledge of the process inversely relates to freedom to make changes to your process.
Our experts are only a message away to help you understand the impact of any of these aspects and make informed decisions on outsourcing.
We’d be happy to discuss and help you bring cell therapies to patients.