clinical-trial-manufacturing
Is stability testing a bottleneck in your clinical trial manufacturing, pushing IND timelines back by months? Learn how predicting three months of stability in just three weeks can de-risk your program and accelerate your submission.
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What if Three Months of Stability Testing Could Be Predicted in Three Weeks?
Quick Facts: The High Cost of Formulation Delays
An Action Plan to Reduce Risk and Speed Up Your CMC Package
Move Forward with Confidence
Literature
What if Three Months of Stability Testing Could Be Predicted in Three Weeks?
For a Director of CMC, the pressure to meet an IND submission window is huge. You have optimized the molecule and navigated preclinical development, but now the critical path depends on developing a stable, scalable drug product formulation. Every failed stability run or unexpected aggregation issue costs precious time, pushing timelines back by months and adding lots of money. One survey found that 60% of biotech professionals reported project failures or big delays due to formulation challenges alone. [1] This bottleneck not only threatens your timeline but also makes your whole program riskier.
You know well that the decisions made now have big impacts. An unstable formulation can lead to costly cold-chain logistics, difficult tech transfer, and potential regulatory holds. [2, 3] Insufficient stability data for clinical materials often delays IND/IMPD submissions. [4] The challenge is to move quickly without skipping the careful science needed to build a strong CMC package that regulators will like and ensures patient safety. Traditional, trial-and-error formulation screening is often too slow and uses too much material, especially for complex biologics where the drug substance itself is a scarce resource. [5, 6]
Quick Facts: The High Cost of Formulation Delays
Timeline Risk: Roughly half of development programs delayed by formulation issues are set back by more than 12 months. [1]
Failure Rates: An estimated 30% of drug candidates that reach Phase I trials do not advance to Phase II, with formulation and stability being key factors. [7]
Cold-Chain Costs: The global cost of pharmaceutical cold-chain failures is estimated at $35 billion annually. [8] A stable, liquid formulation can significantly reduce this dependency.
An Action Plan to Reduce Risk and Speed Up Your CMC Package
A modern, data-first approach can turn formulation development from a slow bottleneck into a smart advantage. By integrating predictive modeling with high-throughput analytics, you can gain control over your timeline and make confident decisions faster.
1. Predict Developability and Stability with AI-Guided Design
Instead of slow, repetitive trial-and-error, a predictive approach uses computer models to screen thousands of potential excipient combinations. [5, 9] Our SMART Formulation® platform analyzes your molecule’s unique biophysical characteristics to identify degradation pathways and predict how likely aggregation is before much lab work begins. [10] This helps you eliminate bad choices early and focus resources on a smart experimental plan. This data-driven process shortens the initial screening phase from months to weeks, saving valuable drug substance and speeding up the path to a lead formulation.
2. Engineer for Room-Temperature Stability and Reduce Cold-Chain Dependency
The logistics and cost of the cold chain are a big challenge, especially for global clinical trials. More than 85% of biologics need cold storage, which costs a lot and can lead to problems. [11, 12] We focus on developing formulations optimized for stability at 2-8°C and even room temperature. [13] Through advanced techniques like lyophilization cycle optimization, our ExPreSo® analytics platform finds formulations that stay stable without needing ultra-cold storage. As one client found after using this approach, stabilizing their lead AAV candidate at ambient temperature removed a lot of logistical complexity for their upcoming Phase I trial. [14, 15] For those candidates that still require it, a deep understanding of the lyophilization process is key for success. You can learn more about Mastering the Scale-Up of Lyophilization Processes for Biologics: Avoid IND Timeline Risks in our dedicated article.
3. Deliver a Scalable, IND-Ready Formulation Package
The main goal is not just a stable formulation, but one that can be manufactured and is supported by a complete data package for regulatory submission. A Quality by Design approach [16] is built into our process, making sure that key quality traits are identified and controlled from the start. This organized way [17, 18, 19] links formulation parameters directly to product quality, which is exactly what regulators like the FDA want. We deliver a strong CMC data package [20] that includes forced degradation studies, long-term stability data projections, and a clear design space. This reduces the chance of questions during regulatory review and makes tech transfer to your manufacturing partner easier.
[21, 22, 23]
Move Forward with Confidence
Your timeline is fixed, and too much is at stake for guesswork. A scientific, data-driven formulation strategy is the best way to reduce risk, speed up your IND submission, and build a strong foundation for later clinical success. Don't lose time to formulation failures you can avoid.
Schedule a strategy call with our formulation experts—accelerate CMC, reduce risk, and move forward with confidence.
Accelerate Your CMC
IND-ready · De-risked · Scale-tested · Room-temp optimized · No guesswork
Literature
[14] Lyo 101: Challenges & Solutions in Lyophilization Cycle Development. VXP Pharma. Accessed November 24, 2025.
[2] Pitfalls of Chemistry, Manufacturing, and Controls in Investigational New Drug Preparation. Advarra. May 17, 2021.
[5] Evaluation of predictive computational modelling in biologic formulation development. MIT DSpace. December 15, 2017.
[3] Clinical Trial Manufacturing: Challenges and How to Overcome Them. PharmSky Research. July 2, 2025.
[24] Overcoming the Top Three Challenges to Lyophilization. The McCrone Group. Accessed November 24, 2025.
[15] What’s Involved in Designing Effective Lyophilization Cycles? Sharp Services. Accessed November 24, 2025.
[25] What's involved in designing effective lyophilization cycles? Clinical Trials Arena. August 5, 2024.
[21] 9 Common Tech Transfer Pitfalls To Avoid. Bioprocess Online. July 24, 2024.
[17] Yu, L. X., Amidon, G., Khan, M. A., Hoag, S. W., Polli, J., Raju, G. K., & Woodcock, J. (2014). Understanding pharmaceutical quality by design. The AAPS journal, 16(4), 771–783.
[26] Key Concerns in Lyophilization Cycle Development. VXP Pharma. Accessed November 24, 2025.
[20] Wechsler, J. (2007). FDA Encourages Quality by Design Initiatives. BioPharm International, 20(10).
[16] Should CMC be a Challenge for IND Preparation? Aleon Pharma. August 7, 2020.
[27] Forman, K. (2022). Meeting tech transfer challenges when manufacturing new biopharmaceuticals. Drug Discovery World. September 7, 2022.
[22] Mitigate Risks for Reliable Product Tech Transfers. Patheon pharma services. Accessed November 24, 2025.
[23] Technology Transfer in Pharma Manufacturing: Best Practices and Pitfalls to Avoid. LinkedIn. May 21, 2024.
[28] What are the common risks in pharma tech transfer? IDBS. March 18, 2025.
[29] The 3 biggest challenges in the clinical trial supply chain. N-SIDE. June 6, 2022.
[30] CMC In IND Applications: What Biotech Innovators Must Know To Stay FDA-Ready. BioBoston Consulting. October 9, 2025.
[11] Overview of the US Pharmaceutical Cold Chain: Costs, Trends, and Challenges. TCP. September 10, 2024.
[18] Quality by Design (QbD) in Drug Development. Pharmuni. Accessed November 24, 2025.
[4] Key Steps for Successful CMC Authoring of IND and IMPD Submissions. MMS Holdings. Accessed November 24, 2025.
[1] Drug Formulation Development and Clinical Trials, an Abbreviated Guide for Biotech Companies. Tayana Solutions. Accessed November 24, 2025.
[19] What is Quality by Design and why should you care? Proveris Scientific. Accessed November 24, 2025.
[31] Maximizing Drug Formulation for First-in-Human Trials. Altasciences. Accessed November 24, 2025.
[32] What are the Challenges Involved in Supplying New Drugs for Clinical Trials? Lonza. October 14, 2022.
[6] Mirjafary, Z. (2025). Predictive Modeling for Small-Molecule Formulation Development Using Advanced Algorithms. Pharmaceutical Technology, 49(10).
[33] Quality by design. Grokipedia. November 20, 2025.
[34] Regulatory Challenges in Clinical Testing for New Pharmaceuticals. Pharma Focus Europe. Accessed November 24, 2025.
[9] From Molecule to Formulation: A Systematic Approach to Assess Biologics Developability. Catalent. October 20, 2025.
[7] Addressing Clinical Trial Challenges and High Drug Development Costs. TechTarget. May 25, 2023.
[35] Predictive modeling for solubility and bioavailability enhancement. CPL. March 19, 2024.
[10] Successful Formulation Development for Biologics Using a Unique Biophysical Prediction and Screening Platform. Pharma's Almanac. February 15, 2024.
[36] Early Formulation - Shortening the development timelines. Pharma Focus Asia. Accessed November 24, 2025.
[37] Transitioning from Formulation Development to Phase 1 Clinical Trials. Quotebeam. Accessed November 24, 2025.
[38] Biologics Formulation Development: Stability & Delivery. Bioprocess Online. Accessed November 24, 2025.
[8] The critical role of cold chain logistics: Safeguarding drug integrity from lab to patient. Cytiva. January 15, 2025.
[13] The cold chain in pharma: Chilling precision with booming growth. Tive. September 25, 2024.
[39] Breakthroughs in Biologic Drug Formulation Stability. Pharma Advancement. February 21, 2018.
[40] IND Application Guide: A Roadmap to FDA Approval Success. Indero. Accessed November 24, 2025.
[41] Developing Formulations for Phase 1 Clinical Trials. Clival Database. December 10, 2024.
[12] Wang, W., Chen, S. C., & Lee, D. (2021). Grand Challenges in Pharmaceutical Research Series: Ridding the Cold Chain for Biologics. Journal of pharmaceutical sciences, 110(2), 603–604.
[42] Loss of drug substance - the challenges and chances of product loss. Single Use Support. August 24, 2021.
[43] Pharma cold chain, a billion dollar global industry. Kool-ex. Accessed November 24, 2025.
[44] Overcoming Challenges Associated with Biologic Drug Formulation and Development. West Pharmaceutical Services. Accessed November 24, 2025.
