Failing to Plan is Planning to Fail: 3 Mistakes Biotech Startups Make Taking a Drug from Bench to Clinic (and How Ab Initio Gets It Right)

Introduction

Taking a drug from the lab bench to the clinic is one of the most critical and challenging transitions in biotech. It’s the point where bold science must meet the strict demands of regulated manufacturing, and where startups, under pressure to move fast, often hit costly and avoidable roadblocks.

At Ab Initio, we specialise in bridging this gap. With decades of experience in formulation development, GMP manufacturing, and regulatory strategy, we’ve helped dozens of emerging biotechs move from concept to clinic without losing momentum, and importantly….. money.

We’ve seen where things go wrong: no shelf-life data, no scalable formulation, rushed timelines, missing documentation, and failures in the clinic due to poor planning or bad advice. These mistakes are common but entirely avoidable.

This article unpacks three of the most expensive and disruptive missteps biotech startups make before manufacturing and shows how Ab Initio’s integrated R&D-to-GMP model helps innovators navigate these risks with confidence, speed, and compliance.

1. Fit for Trial, Fit for Success: Aligning Supply Timelines with Clinical Strategy

While GMP certification isn’t always legally required for clinical material in Australia under the CTN scheme, ethics committees and sponsors expect product to be made to GMP-equivalent standards. In reality, locally compounded material often lacks the quality controls, traceability, and documentation needed for global compliance or later-phase development.

A US-based biotech planned to run its first-in-human trial in Australia, drawn by the streamlined CTN process. However, with multiple suppliers, disconnected timelines, and no clear manufacturing strategy, they faced major delays—clinical sites were ready, but the drug product wasn’t. Ab Initio was brought in to take control of the supply chain. We aligned formulation activities, secured GMP manufacturing slots, coordinated release testing, and managed logistics to ensure timely delivery to clinical sites. By integrating these moving parts under a single strategy, we delivered trial-ready product just in time for first patient dosing…. keeping the program on track.

Misalignment between clinical planning and manufacturing readiness is a common but avoidable pitfall. Delays in ethics submissions, site activation, or dosing often stem from the assumption that GMP material will be “ready in time”,without accounting for the lead times required for stability studies, release testing, or documentation.

At Ab Initio, we integrate clinical timelines and manufacturing strategy from the outset. We map critical path milestones, identify and mitigate supply chain risks, and ensure buffers are built in where needed. Starting with GMP early allows our clients to generate critical quality and stability data from day one—laying the foundation for a complete, compliant CMC package. The result is simple: your product is ready when your trial is, and your program advances without disruption.

2. Getting Shelf Life Right: Why Critical Quality Attributes, Stability, and ICH Compliance Matter from Day One

If you're running a trial over a year and need a 12-month shelf life, you must demonstrate that stability has been conducted to ICH standards to justify the shelf-life. Failing to do this can delay your program by months or even years.

A biotech client approached Ab Initio with a promising formulation that had successfully completed a Phase 1 study and was ready to progress to Phase 2. However, they had no stability data or impurity profile to support the trial duration. Within weeks, we designed and executed a stability program aligned with ICH guidelines, identified key degradation pathways, and generated the documentation needed to support a provisional shelf life—allowing their trial to proceed on schedule.

One of the most overlooked challenges in early development is the failure to fully characterise the critical quality attributes (CQAs) of the product; particularly the stability of the API, the behaviour of the formulation over time, and the identification and control of related substances.

At Ab Initio, we build stability studies, impurity profiling, and ICH-aligned documentation into our programs from day one. Our integrated R&D-to-GMP model ensures that by the time your product enters manufacture, it is supported by a well-defined stability profile, validated analytical methods, and the data needed to establish shelf life, enabling faster, compliant progression into later-phase trials.

3. From Bench to GMP: Planning for Manufacturability from the Start

Identifying the route of administration and target product profile from the start ensures you enter clinic with a formulation and commercialisation strategy that will speed-up to time to market.

A university spinout came to Ab Initio with compelling preclinical data, but no finished product or strategy for scale-up. Their lab work had been focused on the drug substance alone and used an unsophisticated vehicle that wasn’t suitable for the intended indication. We worked closely with their team to design a fit-for-purpose dosage form, identify scalable and regulatory-compliant materials, and manufacture GMP-aligned clinical trial supplies.

Startups often prioritise proof-of-concept and speed to clinic, leaving manufacturability as an afterthought. This can result in lab-based processes that don’t scale, require unavailable equipment, or aren't aligned with regulatory expectations—issues that typically emerge late, when time and capital are limited.

At Ab Initio, we bridge R&D and GMP from day one. Our team reviews formulation strategy early with scale-up, regulatory requirements, and commercial viability in mind. We simulate GMP conditions in early development runs, identify critical process parameters, and ensure all materials are appropriate for scale and compliance. The result is a product that’s not only effective in theory—but ready for the clinic and beyond.

Conclusion

The road from lab bench to clinical trial is filled with high-stakes decisions and missteps at this stage are costly. Whether it’s trial delays due to missing supply, shelf-life issues that stall progression, or a formulation that can’t be scaled, each of these mistakes can derail your development timeline, strain resources, and shake investor confidence.

At Ab Initio, we help biotech innovators avoid these pitfalls by integrating R&D, regulatory foresight, and GMP execution into a seamless pathway. Our end-to-end capabilities from formulation development and analytical validation to GMP manufacturing and clinical supply are designed to support your success, not slow you down.

If you’re preparing to move into clinical trials, now is the time to get it right. Let’s plan it properly together.