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Facing high-stakes IND timelines? CMC deficiencies and slow, fragmented formulation strategies risk months of delays. Learn how integrated services can predict stability faster and accelerate your drug product development.
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Your CMC Clock is Ticking: Get a Faster, More Stable Formulation with Integrated Services
The High Cost of a Disconnected Formulation Strategy. [1]
From Uncertainty to Control. [27]
Literature
Your CMC Clock is Ticking: Get a Faster, More Stable Formulation with Integrated Services
What if three months of stability testing could be predicted in just three weeks? For drug product development leaders, that question isn’t hypothetical. It’s a direct challenge to the high-stakes timeline for a successful Investigational New Drug (IND) submission. With recent FDA data showing that over 33% of clinical holds come from Chemistry, Manufacturing, and Controls (CMC) deficiencies, the room for error in formulation has disappeared. A single unexpected aggregation event or failed stability run can trigger months of delays, risking financing, competitive positioning, and the path to Phase 1. [1]
You have optimized the molecule and the pressure from the board is mounting. [1] Now, the IND submission window is closing, and formulation has become the critical bottleneck. Every day spent on iterative, trial-and-error screening is a day you don’t get back. A reactive approach, waiting for stability data to confirm what works, is no longer possible when a single CMC-related delay can put a program behind for most of a year.
The High Cost of a Disconnected Formulation Strategy. [1]
A conventional, sequential approach to formulation is a main source of risk in drug development. When developability assessment, formulation screening, process development, and stability testing are treated as separate stages, critical flaws often show up too late. This fragmented workflow creates predictable problems that appear at the worst possible times.
Failed Stability and Forced Degradation: Unforeseen degradation pathways can make a lead candidate unusable, forcing a complete reformulation. Protein aggregation, hydrolysis, and oxidation are common failure points that traditional screening methods may not detect until months into a stability study.
Late-Stage Surprises During Scale-Up. [4] A formulation that appears stable in a lab setting can fail under the stress of manufacturing-scale processes like pumping, filtration, and filling. These shear-induced stresses can trigger aggregation and particle formation, leading to costly batch failures and tech transfer delays. [4]
Over-reliance on Cold Chain Logistics. [6, 7] Without a proactive strategy to get stability at higher temperatures, teams often default to frozen formulations (≤ -60°C). Relying on this creates really complicated logistics and cost. The global cost of pharmaceutical cold chain failures is estimated at $35 billion annually, a burden that begins with early development decisions. [8, 9]
These issues are not just scientific hurdles; they are business risks that directly impact timelines and budgets. [10, 26] An integrated approach is needed to move from a reactive to a predictive formulation strategy. This starts with a data-driven approach to biologic formulation design that predicts challenges before they stop your program.
Quick Facts: The Value of an Integrated Approach. [22, 23, 24]
Accelerate Timelines: Reduce formulation screening from months to weeks with predictive modeling.
Reduce Risk: Identify and address stability weaknesses and degradation pathways before they cause late-stage failures.
Reduce Costs: Cut down on using expensive and complex cold-chain logistics by designing for ambient stability. [4]
Deliver with Confidence: Create a strong, QbD-aligned data package to support a successful IND submission on the first attempt. [10, 26]
From Uncertainty to Control. [27]
In today’s competitive landscape, you cannot afford to let formulation challenges control your development timeline. The difference between meeting your IND submission window and facing a nine-month delay lies in the strategy you use from the start. By shifting from a conventional, fragmented process to an integrated, predictive model, you replace uncertainty with control. An integrated partner provides not just data, but a clear, accelerated path forward, making sure your innovative molecule is built on a strong base of stability, scalability, and regulatory readiness.
Schedule a strategy call with our formulation experts: accelerate CMC, reduce risk, and move forward with confidence.
Accelerate Your CMC
Mini-benefits: IND-ready · De-risked · Scale-tested · Room-temp optimized · No guesswork
Literature
Center for Drug Evaluation and Research. (2024). Advancing Health Through Innovation: New Drug Therapy Approvals 2023. U.S. Food and Drug Administration.Current time information in नागपूर डिव्हिजन, IN.
Diez, J. M., et al. (2022). Artificial intelligence in drug formulation and delivery. [13] Advanced Drug Delivery Reviews.
Glick, J. (2021). The cost of getting a new drug to market is $2.6 billion. [28] The Catalyst.
Jorda, J., et al. (2023). Machine learning for prediction of protein formulation stability. [11] Trends in Pharmacological Sciences.
Rathore, A. S. (2009). Quality by design for biopharmaceuticals. [18] Nature Biotechnology.
Riley, R. S., et al. (2021). The challenges of drug development and approvals. [29] The Regulatory Review.
Shukla, D., et al. (2021). The role of formulation in the development of biologics. [19] AAPS PharmSciTech.
Singh, S. K., et al. (2018). Challenges in the technology transfer of biopharmaceutical drug products. [6] Journal of Pharmaceutical Sciences.
Sola-Visner, M. (2021). Chemistry, Manufacturing, and Controls (CMC) Post-Approval Changes: A Review of the Regulatory Landscape. [30] AAPS PharmSciTech.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2009). [20] ICH Harmonised Tripartite Guideline: Pharmaceutical Development Q8(R2).
World Health Organization. (2022). Annex 4: WHO guidelines on stability testing of active pharmaceutical ingredients and finished pharmaceutical products. [21] WHO Technical Report Series.
Zydney, A. L. (2016). Protein aggregation: pathways, mechanisms, and implications for formulation development. [7] Current Opinion in Biotechnology.
