When an injectable molecule reaches the clinical starting line, many drug owners have one big question top-of-mind: How quickly can we fill a batch and start our in-human trial?
At this point in product development, acceleration is a natural urge. But while it’s tempting to prioritize speed, it’s important to remember that the lab-to-clinic pivot also involves many new decisions and priorities that should always be approached strategically and never rushed.
Partnering with a forward-thinking CDMO can help turn those strategic choices into the foundation of robust manufacturability, regulatory and scale-up readiness and of course, a successful clinical batch. Following these four key principles can help make that possible for you and your partner.
Map the sequence of vital decisions
On the path from candidate selection to a released clinical batch, drug owners must make a series of key decisions that frequently inform and impact each other — and that shape many downstream development options.
For example, the selection of primary packaging influences specific material requirements, which inform the QbD design space and process development. These, in turn, may guide analytical methods and control strategies. Together, these choices advise regulatory documentation supporting an IND.
Collaboratively mapping these decision sequences is often the first step towards both a high-quality filling material for in-human trials and a valuable CDMO partnership. Starting here sets the entire project up for success.
Think beyond the lab during formulation development
Even on the benchtop, it’s important to ask how today’s pre-clinical decisions will impact batch goals.
An unconventional excipient may unlock valuable molecular qualities, but can it be sourced at clinical scale? A unique compounding step may be manageable in the lab, but is it practical at higher volume? Ask these questions early: they can help your molecule travel more efficiently from a pre-clinical lab to a GMP environment.
Product vulnerabilities matter just as much. Light, temperature and further sensitivities identified in the lab should be communicated to the manufacturing partner in time to guide process design. It helps protect product quality, your precious API and operators on the filling line.
Choose primary packaging with the future in mind
Vials are often the assumed choice for a clinical batch. But for many programs, defaulting to this familiar format can deliver short-term efficiency gains at the cost of longer-term wins. As care rapidly shifts from clinic to home, lifecycle leaps like a delivery device may arrive much sooner than once expected. It may be smart to consider an early investment in a primary packaging format such as a syringe to streamline downstream product evolution.
When you select your container, your CDMO can also help you consider multiple manufacturability parameters that often impact future production priorities. The format you choose should support both early-phase fills and commercial-scale production, and it must be compatible with your product and your service providers' production plants.
Plan for the operational realities
One factor can be particularly easy to underestimate: transferring and documenting analytical methods. Successful method transfer depends heavily on knowledge exchange, which can take additional time.
Quality agreements, contracts and audits often take longer than programs expect. This also applies to the recommended inclusion of a technical batch prior to a CTM fill. Building that time into the plan helps protect the overall timeline.
Learn from a team with decades of experience
Ultimately, each lab-to-clinic leap will have its own set of intricacies. Modality, formulation complexity and regulatory strategy all shape the path. The constant: It’s essential to think through these priorities deliberately, with the right manufacturing perspective at the right time.
At Vetter, our development teams in Chicago and Rankweil work with biotech and pharma customers through this transition every day. Our on-demand webcast, “Master the Leap from Lab to Clinic,” walks you through how to plan the move from pre-clinical to clinical for sterile injectables, with practical guidance from our experts. Watch the webcast to learn more.
To learn more about Vetter, get in contact with us.
