high-throughput-formulation-screening-for-biologics
Is conventional biologic formulation stalling your progress and budget? High-throughput screening can predict months of stability testing in weeks, accelerating your program. Discover how to overcome these critical bottlenecks.
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From Months to Weeks: Accelerating Biologic Formulation with High-Throughput Screening
Quick Facts: The Formulation Bottleneck
Literature
The High Cost of Formulation Delays
An Action Plan for Predictable, Scalable Formulations
Deep Dive: Building Confidence for CMC and Regulatory Success
From Months to Weeks: Accelerating Biologic Formulation with High-Throughput Screening
What if three months of stability testing could be predicted in three weeks? For drug product leaders, the time lost to conventional, iterative formulation screening is a critical bottleneck, delaying IND submissions and adding significant risk to a program where the overall likelihood of approval from Phase I is already just 7.9%. [1] You have a promising molecule, but progress is stalled by formulation challenges that threaten your timeline and budget.
The High Cost of Formulation Delays
You know the pressures well. The IND submission window is closing, and every failed stability run or unexpected aggregation event costs precious time. [2] Conventional formulation development, relying on low-throughput, one-factor-at-a-time experiments, is often too slow and inefficient to meet the demands of accelerated programs. [3] This approach frequently fails to uncover the complex interactions between excipients and the biologic, leading to suboptimal formulations that require costly cold-chain logistics or fail during scale-up.
These delays are not just inconvenient; they have serious financial consequences. The biopharma industry loses an estimated $35 billion annually from failures in temperature-controlled logistics alone, a cost amplified by formulation choices that mandate refrigerated or frozen storage. [4] A poorly optimized formulation can introduce risks that jeopardize the entire development program, from triggering an immune response in patients to failing to meet the rigorous standards of a CMC package. [2, 5]
Quick Facts: The Formulation Bottleneck
High Failure Rate: Approximately 90% of drugs that enter clinical trials fail, with formulation stability being a key factor. [6]
Costly Delays: Each day of delay in development can cost a company millions in lost revenue, making efficient formulation critical. [7]
Cold-Chain Burden: Failures in temperature-controlled logistics cost the biopharma industry $35 billion annually, a risk that can be mitigated with thermally stable formulations. [4]
Proven Solutions: Leukocare has delivered over 350 stable formulations for complex biologics, accelerating CMC timelines for our partners.
An Action Plan for Predictable, Scalable Formulations
Instead of relying on slow, iterative screening, you can adopt a systematic, high-throughput approach that combines predictive modeling with intelligent experimentation. This method de-risks development by identifying optimal, stable formulations in a fraction of the time.
1. Predict Developability with AI-Guided Design
The process begins by using advanced algorithms to predict how your molecule will behave in a wide range of conditions. AI-driven platforms analyze vast datasets to identify the most promising combinations of buffers and excipients, eliminating months of guesswork. [8, 9, 10] This data-informed strategy allows for the creation of a smaller, smarter experimental design focused on the highest-potential candidates. For teams seeking to improve their formulation strategy, understanding how to apply ML-guided excipient selection can be a significant advantage.
2. Optimize for Stability and Reduce Cold-Chain Dependency
Once the initial candidates are identified, high-throughput screening (HTS) techniques are used to rapidly test them against multiple stress conditions, such as temperature shifts and agitation. [3, 11] This allows for the selection of a formulation that not only prevents aggregation and degradation but is also optimized for real-world conditions. [2, 12] The goal is to achieve a product with enhanced shelf-life at room temperature, which can significantly reduce the logistical complexity and cost associated with cold-chain shipping and storage. Developing robust ambient temperature storage solutions is a key objective for reducing these operational burdens. For biologics intended for self-administration, achieving stability in subcutaneous high-concentration biologics is a critical milestone.
3. Deliver an IND-Ready Package That Scales
The final step is to deliver a comprehensive data package that supports your IND submission. This includes full stability and characterization data, ensuring that your formulation is not only stable but also manufacturable and compliant with regulatory expectations. By following Quality by Design (QbD) principles from the start, this approach ensures the formulation is robust and ready for tech transfer and scale-up without late-stage surprises. [13, 14, 15] For certain molecules, a liquid-to-lyo formulation conversion may be necessary to ensure long-term stability, a process that benefits from predictive modeling.
For example, one team stabilized their lead AAV candidate at room temperature after using a predictive, high-throughput screening platform. What previously took them months of iterative screening was completed in just a few weeks, providing a stable formulation that passed IND submission requirements on the first attempt and eliminated the need for costly reformulation.
Deep Dive: Building Confidence for CMC and Regulatory Success
A good formulation strategy comes from solid science and understanding regulations. The objective is to build a comprehensive understanding of the product and process, which is a core tenet of the QbD framework endorsed by regulatory agencies. [13, 14, 16]
By systematically mapping the interactions between your molecule and various excipients under different stress conditions, you generate a "design space." This provides a detailed understanding of which formulation components are critical to maintaining product quality attributes like potency and purity. This data is essential for your CMC submission, as it demonstrates a deep understanding of your product and justifies your chosen formulation. [17]
This approach makes tech transfer and scale-up less risky. A well-characterized formulation with a defined design space is less likely to encounter unexpected stability issues during manufacturing, preventing costly delays and batch failures. For advanced treatments like viral vectors, where stability is a big challenge, this detailed characterization isn't just helpful—it's crucial.
Move forward with a formulation designed for regulatory success, built on data, and ready to scale. [18, 19, 20]
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
Ascendia Pharmaceutical Solutions. (2022, August 22). Biologics Formulation Challenges. [21]
Pharmaceutical Commerce. (2017). Pharmaceutical cold chain logistics is a $13.4-billion global industry. [22]
IDBS. (2019, July 22). Challenges in Formulating Biologics. [2]
CovalX. (2019, April 26). Overcoming Challenges Associated with Biologic Drug Formulation & Development. [23]
PharmaTrax. (n.d.). Failures in temperature-controlled logistics cost biopharma industry billions. [4]
CPHI Online. (2021, February 17). Clinical Development Success Rates and Contributing Factors 2011-2020: New Report from Informa Pharma Intelligence. [24]
Bioprocess Online. (n.d.). Biologics Formulation Development: Stability & Delivery. [25]
Leukocare. (n.d.). Formulation Development for Complex Biologic Drugs: A Guide. [26]
Patsnap Synapse. (2025, March 20). What are the common challenges in biologic drug development? [5]
Patsnap Synapse. (2025, May 9). FDA IND Process for Biologics: Timeline and Key Requirements. [17]
TCP. (2024, September 10). Overview of the US Pharmaceutical Cold Chain: Costs, Trends, and Challenges. [27]
BioPharm International. (2016, June 6). Diverging Results in Clinical Success Rates for Biologics. [28]
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Preprints.org. (2024). AI and Machine Learning in Formulation Development. [8]
PubMed Central (PMC). (n.d.). Harnessing the AI/ML in Drug and Biological Products Discovery and Development: The Regulatory Perspective. [9]
Knowledge Portal on Innovation and Access to Medicines. (n.d.). R&D Time and Success Rate. [30]
Best Cold Storage In India. (n.d.). Pharma cold chain, a billion dollar global industry. [31]
BioBoston Consulting. (2025, October 20). IND Application Timeline: Key Milestones and Regulatory Deadlines. [32]
Sofrigram. (n.d.). Focus on TCO to optimize the supply chain. [33]
Journal of Chemical and Pharmaceutical Research. (n.d.). The Impact of Formulation Strategies on Drug Stability and Bioavailability. [12]
PubMed Central (PMC). (n.d.). Progress and challenges in viral vector manufacturing. [18]
PharmSky Research. (2025, November 20). How Formulation Decisions Impact Drug Stability and Bioavailability. [34]
Pharmaceutical Technology. (n.d.). Quality by Design for Biologics and Biosimilars. [13]
ACS Publications. (n.d.). Design of Biopharmaceutical Formulations Accelerated by Machine Learning. [10]
BioPharm International. (n.d.). Quality by Design for Biotechnology Products—Part 1. [14]
YouTube. (2021, May 11). QbD in Biologics Drug Product Development and Manufacturing. [35]
Fierce Biotech. (2012, February 10). High price of failure drives drug development costs into the stratosphere. [7]
Kivo. (2023, August 30). How To Submit An Investigational New Drug (IND) Application. [36]
53Biologics. (2022, June 13). Quality By Design in Biologic Drug Development. [15]
BioPharm International. (2022, July 1). Improved Formulations to Enable Stable Delivery of Biologics. [37]
Pharma's Almanac. (2024, October 29). Designing Quality into Biomanufacturing. [16]
Biotechnology Innovation Organization | BIO. (2021, February). Clinical Development Success Rates and Contributing Factors 2011–2020. [1]
PubMed Central (PMC). (n.d.). Approval success rates of drug candidates based on target, action, modality, application, and their combinations. [38]
Merck Group. (n.d.). Harnessing AI To Speed Up Drug Formulation. [39]
American Pharmaceutical Review. (n.d.). Optimizing Pharmaceutical Viral Vector Production: Techniques and Challenges. [19]
NIH Clinical Center. (n.d.). U.S. Investigational New Drug Application → IND Application Process. [40]
Pharmaceutical Technology. (2017, June 19). Counting the cost of failure in drug development. [41]
Single Use Support. (2023, October 23). Challenges in viral vector production & innovative solutions. [20]
ResearchGate. (2025, August 7). Manufacturing Challenges and Rational Formulation Development for AAV Viral Vectors. [42]
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American Pharmaceutical Review. (2023, December 1). The Challenges and Solutions for Viral Product Development and Manufacturing. [44]
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PubMed. (n.d.). Utility of High Throughput Screening Techniques to Predict Stability of Monoclonal Antibody Formulations During Early Stage Development. [3]
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ResearchGate. (2025, August 6). High Throughput Screening of Protein Formulation Stability: Practical Considerations. [11]
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