How to Select the Right Biologics CDMO Partner

When selecting a biologics contract development and manufacturing organization (CDMO) partner—whether you need mammalian or microbial capabilities—the decision-making process follows a similar process. As discussed in "Evaluating Biologics CDMOs: Tips for Crafting an RFP," your ultimate goal is selecting a partner that can manufacture product of consistent quality at the needed scale, within your allocated budget, and in your required timeline.

To simplify this complex decision-making process as much as possible, it helps to segment essential and strategic CDMO partner characteristics. These essential capabilities and organizational traits are non-negotiable, as they are necessary to achieve the ultimate goal of releasing an FDA-approved therapeutic to the market.

Once you have narrowed your list using the essentials, the remaining strategic characteristics of a potential biologics CDMO partner will be the focus of your decision-making process. You are unlikely to find a partner that checks every box on your wish list; therefore, you must determine the capabilities and qualities that are most important to your program’s success.

Essential Biologics CDMO Attributes

While there are many variables, considerations, and usually a concession or two within the CDMO selection process, some characteristics are musts.

• Does the biologics CDMO have the needed manufacturing capabilities, including the required equipment and teams with the needed expertise to execute your program?
• Does the organization have the capacity to manufacture the needed product within your timelines?
• Does the CDMO have phase-appropriate, GMP-compliant quality management systems?
• Are the CDMO's unit operations fit for manufacturing, and are they scalable?
• Does the biologics CDMO’s program management team communicate effectively, and are they responsive?
• Does the CDMO have the regulatory experience and track record required to execute your program?
  
  

If the answer to any of the above questions is "no," then you must disqualify the organization and continue your partner selection search.

Weighing Strategic CMDO Partner Characteristics

Each company on your potential biologics CDMO partner shortlist will have all of the attributes essential for your program's success. Now, it is time to consider the gap analysis your organization conducted to create your request for proposal (RFP) and the long-term vision for your program.

Fully Integrated Biologics CDMO

Fully integrated CDMOs, or one-stop shops, eliminate the need to source and manage multiple CDMO relationships. Because a fully integrated biologics CDMO will develop processes and execute them, there is less risk when challenges inevitably arise. Additionally, end-to-end CDMOs can typically expedite your program's timeline and reduce costs by avoiding expensive and time-consuming tech transfers.

Also, integrated CDMOs will typically have multiple modality production capabilities or expression system capabilities, which offers flexibility if your program must take a directional turn.

Facility Considerations

The cleanroom manufacturing environments tend to be the focal point when making biologics CDMO partner selection decisions. However, a CDMO’s facility or multiple facilities should be wholistically considered because the facility's overall layout, workflow, and systems will ultimately determine the facility's efficiency. Having the space for logical workflows and storage will maximize efficiencies, reduce errors, and minimize delays. Additionally, when process development and analytical groups are integrated and located on the same campus, it makes internal and external knowledge sharing easier.

Finally, which processing platforms are used? Does the facility use single-use systems (SUS), stainless steel, or is it a hybrid facility? As discussed below, there are numerous benefits to full SUS facilities.

Risk Mitigation

While risk mitigation is always critical to any development or drug manufacturing program, single-use bioprocessing facilities offer unique advantages. Arguably, and most importantly, contamination and cross-contamination risks are dramatically reduced.

Additionally, single-use bioprocessing systems are much easier to scale, avoiding the risk of complications and the potential of additional biologics process development work as your program progresses.

Ease of Scale Up

Are the biologics CDMO’s equipment platforms consistent across scales of production? Specifically, do the equipment and parameters used in the biologics process development space align with clinical and commercial manufacturing scales? For multiple reasons, including scale-up efficiency and effectiveness, Scorpius BioManufacturing’s facility uses entirely single-use bioprocessing systems.

Ongoing Process Excellence

Some biologics CDMOs, Scorpius BioManufacturing among them, dedicate ongoing attention and resources to continuous process optimization. Using process optimization tools and principles like Lean, Six Sigma facilitates efficient and effective product quality and consistency, waste reduction, and improvement of workstreams across the production processes.

Analytical Method Development & Validation

Biologics CDMOs with analytical capabilities for ample CMC support are necessary for most innovators. Additionally, selecting a partner with the expertise to develop novel product-specific tests and product characterization methods for early-phase product development is often valuable. Your program might also benefit from a CDMO with the analytical capabilities to analyze patient samples generated throughout clinical trials.

Scale Considerations

While selecting a CDMO with the capacity to manufacture your drug substance is a requirement, selecting a partner that serves program sizes similar to yours is often best. For example, Scopius BioManufacturing was founded to serve the specialized needs of clients with small-volume biologics production projects. These programs usually need focused biologics development attention and are typically not prioritized within large CDMO organizations.

Formulation Capabilities

Your pre-RFP gap analysis will have determined the needed levels of formulation support for bulk drug substance as well as your final drug product. If your program requires robust formulation capabilities, CDMOs with the expertise using Six Sigma and other tools for Design of Experiments (DoE) can be beneficial. However, if your product's formulation is well established, this may not be a consideration of significance.

Global Regulatory Expertise

If your product will be marketed globally, selecting a biologics manufacturing partner with experience working with, managing filings, and being inspected by the international regulatory authorities is crucial.

Your Journey Begins

While selecting a biologics manufacturing partner is challenging, collaborating to ensure a successful program is where the real work begins. There will undoubtedly be challenges; however, transparent communications and ongoing collaboration with the right biologics CMDO will advance your program, ultimately delivering your therapeutic product to waiting patients.

The teams of experts at Scorpius BioManufacturing find working with our innovator clients extremely rewarding; we treat your programs as if they were our own.

The experience and expertise among our executive management, scientific, and operational teams allow us to fill the technical gaps within many of our partners' organizations. Additionally, our nimble, single-use facility was built for today's drug development pipeline, allowing us to manage complex programs on time and on budget.