In the dynamic and high-stakes world of biologics, selecting the right Contract Development and Manufacturing Organisation (CDMO) can make or break your project. Imagine you’re about to launch a rocket – your biotherapeutic is the payload, and the CDMO is your mission control. Get the choice right, and you’ll soar through clinical trials and regulatory approvals. Get it wrong, and you could crash and burn.

In this guide, we’ll arm you with the insights to choose a CDMO that will propel your project toward success.

Laying the foundation: define your priorities for your biotherapeutics clinical development

Before you even think about approaching a CDMO, you need to build your blueprint—a Target Product Profile (TPP). Think of the TPP as your product’s CV, detailing everything a potential CDMO needs to know to bring your biotherapeutic to life.

Your TPP should encompass:

• Product characteristics: it include your product description (What exactly is your biotherapeutics, and what makes it unique?), the indications and usage (What conditions will it treat, and how will it be used?), the dosage forms and strengths: (Will it come in vials, syringes, or IV bags? What concentrations are needed?) and its storage conditions (Will your antibody need to be kept on ice or is room temperature fine?)

By anticipating the dose and clinical indications, you can determine the quantity needed for clinical studies and, consequently, the required production scale. Additionally, considering the route of administration will guide your decisions on the formulation development needed from your CDMO.

• Manufacturing technology and process: What specific technologies and processes will be required?

Your TPP isn’t just a one-time document – it’s a living, breathing plan that will evolve alongside your product. A well-developed TPP will significantly streamline the process of finding the most suitable CDMO for your project.

Once your TPP is set, it’s time to prioritise. In this mission, three factors reign supreme: quality, timeline, and cost. But here’s the catch—you can’t have it all. You’ll need to decide what’s most critical for your project’s success.

• Quality: This is your non-negotiable. Compromise here, and you’re putting the entire project at risk.
• Timeline: If speed is your top priority, be ready to invest more.
• Cost: Tight budget? You might need to adjust your expectations on delivery timelines.

Remember, even the most promising biotherapeutics can encounter turbulence when scaled-up. The complexities of scaling up production can introduce unexpected variables, potentially affecting quality, timelines, or costs. Therefore, choosing a CDMO with the right technological capabilities, experience, and flexibility needed to maintain your project’s momentum, regardless of the challenges that may arise.

Scouting the field: how to pinpoint your ideal CDMO

With your TPP and priorities in hand, the next step is to explore the landscape for potential CDMOs and compile a well-considered shortlist. This is not a task to be taken lightly; it’s akin to assembling an elite team, where every member must be rigorously evaluated.

Avoid the temptation to narrow your options prematurely. Many biotech start-ups, particularly those with Series A funding, may be navigating the CDMO selection process for the first time. It can be tempting to rely on a peer’s recommendation of a CDMO they’ve worked with before. However, this approach carries the risk of limiting your search without fully considering how your biotherapeutic may differ significantly from that of your peer.

Consider meeting potential CDMOs during major industry events or engaging industry consultants to help you identify those that not only meet your technical needs but also align with your company’s values and culture.

With your shortlist in hand, the next step is to draft a Request for Proposal (RFP). Your RFP should be as detailed as possible, drawing heavily from your TPP to define the scope of work, timelines, and expectations. Aim to send your RFP to about 6–8 CDMOs. Not all will bite, but those who do will provide you with the information you need to make an informed choice.

When the proposals roll in, it’s time to dig deep. This is where you separate the wheat from the chaff. Create a comparison matrix that allows you to evaluate each CDMO based on a like-for-like basis. Weight the criteria according to your top priorities and consider potential risks to quality, timeline, and cost. From here, rank your candidates and remain vigilant for any red flags, such as potential risks to quality, timelines, costs, or a mismatch in values and culture.

Key criteria for choosing a biologics CDMO: technology, project management, and location

The technology question: does the CDMO has what it takes?

This is the million-dollar question. Does the CDMO possess the technology to produce your biotherapeutics? Without the right tools and expertise, even the best intentions will fall flat.

Consider:

• Do they have the necessary microbial or mammalian expression systems?
• Can they handle every phase of development, from cell line development to final drug product? If not, are you ok to work with multiple CDMO and handle tech transfers?
• Are their production systems—whether stainless steel or single-use—fit for your needs?
• Do they have the scale-up capabilities required for your production demands?

If they don’t tick all these boxes, it’s time to move on.

Project management: the “silent” engine behind success

Project management isn’t just a box to tick—it’s the engine that keeps your project on track. An exceptional CDMO project manager will meticulously oversee every aspect, from timelines to budgets, ensuring seamless operation. During your site visit, pay close attention to their communication style and whether their organisational culture aligns with your own.

It is wise to engage directly with the individuals who will be working on your project. This allows you to assess their level of expertise and familiarity with your specific requirements. If the CDMO is hesitant to introduce you to the operators or scientists, or if your interactions feel overly managed, it may indicate a lack of transparency and collaboration within the organisation.

Remember, this partnership is a marathon, not a sprint, requiring ongoing collaboration and mutual trust.

Location matters: proximity vs. performance

Location might seem like a minor detail, but don’t underestimate its importance. Especially in the early stages of clinical development, proximity can make or break a project. Close communication and/or frequent visits can pre-empt problems before they snowball. However, if the CDMO is a well-oiled machine with a history of smooth tech transfers, distance might be less of a concern. Ultimately, it’s about your specific needs and how much hands-on oversight you require.

The Right CDMO – A Partnership for Success

Choosing the right CDMO is like finding the perfect partner for a dance – when the match is right, you’ll glide seamlessly through the complexities of drug development, moving in harmony towards a successful clinical development. The journey begins with a solid foundation: your Target Product Profile (TPP). This blueprint ensures that all parties are aligned on the goals and requirements of your biotherapeutic.

Understanding and prioritising the key factors—quality, timeline, and cost—will guide your decision-making process. Quality must be non-negotiable, as it underpins the integrity of your product. Timelines and budgets, while important, must be balanced carefully to avoid compromising your project’s success.

The selection of a CDMO goes beyond technical capabilities. The right partner will not only have the necessary technology and expertise but will also excel in project management, ensuring that timelines are met, budgets are adhered to, and communication is clear and effective. Furthermore, consider the CDMO’s location and its organisational culture. Proximity can enhance collaboration, and a cultural fit will foster a productive and trusting partnership.

Ultimately, the relationship with your CDMO is a long-term commitment, requiring mutual respect, transparency, and a shared vision. By taking the time to carefully assess your options and choose a CDMO that aligns with your needs and values, you’ll set the stage for a successful collaboration, leading to a smooth and successful product launch.