developability-assessment-biologics
The journey from a promising molecule to a viable biologic drug is fraught with pitfalls. Learn how comprehensive developability assessment de-risks your candidate, ensuring consistent manufacturing, stability, and efficacy. Discover practical strategies to get your biologic to the finish line.
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Getting Biologics to the Finish Line: A Practical Look at Developability Assessment
FAQ[2, 6]
1. Current Situation[1, 12]
2. Typical Market Trends[8]
3. Current Challenges and How They Are Solved[10]
4. How Leukocare Can Support These Challenges
5. Value Provided to Customers
Getting Biologics to the Finish Line: A Practical Look at Developability Assessment
For any Director of CMC or Drug Product Development, the path from a promising molecule to a viable biologic drug is long and filled with potential pitfalls. The goal isn't just to find a molecule that works, but one that can be manufactured consistently, remains stable, and is safe and effective for patients. This is where developability assessment comes in. It's not a single step, but an ongoing process of de-risking a candidate to avoid costly late-stage failures.
1. Current Situation[1, 12]
The biologics market is growing, with projections showing an increase from around USD 487 billion in 2025 to over USD 1.1 trillion by 2034. This growth is fueled by advancements in biotechnology and a rising demand for targeted therapies for chronic diseases.[3] With this expansion comes pressure.[4, 5] Teams are pushed to move faster, particularly those with molecules that have fast-track status.
At the same time, the molecules themselves are becoming more complex. We are no longer dealing with just standard monoclonal antibodies; the pipelines now include bispecifics, antibody-drug conjugates (ADCs), and RNA-based therapies. Each new modality brings its own set of challenges related to stability, manufacturing, and delivery.[2, 6] The fundamental task is to identify potential problems early, when you have many candidates and very little material, to make informed decisions before significant time and resources are committed.[7]
2. Typical Market Trends[8]
Several trends are shaping how we approach developability:
Speed and Efficiency: For virtual and small biotechs, the primary goal is often a fast and clean path to a Biologics License Application (BLA) or an Investigational New Drug (IND) application. This requires parallel optimization of the cell line, process, and formulation.
The Rise of Outsourcing: Many companies, especially smaller ones, operate without in-house labs. They rely on a network of contract development and manufacturing organizations (CDMOs) and specialized partners. This makes communication and partner selection critical.
New Modalities: Large pharmaceutical companies are increasingly tackling new and complex modalities. Even with internal resources, they often face experience gaps in specific areas of drug product strategy, such as with viral vectors or RNA.
Data-Driven Decisions: There is a growing reliance on in silico tools and AI-driven predictive modeling to screen candidates and forecast their behavior. This approach helps to optimize development with less experimental effort, which is important when material is scarce.[10]
3. Current Challenges and How They Are Solved[10]
As a CMC or Drug Product leader, you are likely familiar with the common hurdles in developability.
Limited Material and Time: In early phases, you have very little of your precious molecule to work with. Traditional, extensive screening is often not feasible. The solution is to use high-throughput, small-scale assays and predictive analytics to get the most information from the smallest amount of material. This allows for the identification of potential liabilities, such as a tendency to aggregate or low stability, very early in the process.[8]
Finding the Right Partner: Many teams have had poor experiences with service providers who act more like academic labs than true partners. They deliver data without strategic input, leaving the internal team to connect the dots. The key is to find partners who act as co-strategists. These partners should have a strong opinion, backed by experience, and communicate proactively to help build a robust CMC story for investors and regulators.
Onboarding and Internal Hurdles: For mid-size and large pharma, internal processes can be slow and rigid. Onboarding a new vendor through procurement can be a significant pain point, especially for a one-off, specialized project. A common way to break through this is to start with a well-defined pilot project that addresses a specific, tricky challenge, like a new modality or a lyostability issue. This allows a new partner to prove their value without disrupting established workflows.
Generic Solutions for Unique Problems: When tackling a new modality, the last thing you need is a generic, templated solution from a vendor. The challenges with an ADC are not the same as with a monoclonal antibody. Solving this requires a partner with deep technological understanding of specific modalities who can provide tailored materials, case studies, and act as a true sparring partner for internal discussions.
4. How Leukocare Can Support These Challenges
At Leukocare, we work with biotech companies across the spectrum, and we've built our approach to address these specific challenges directly.
For the Fast-Track Biotech Leader, who needs to get to the BLA quickly and without missteps, our Smart Formulation Platform, which uses AI-based stability prediction, provides a forward-thinking, data-driven path. We work as collaborators with your CMC professionals, providing the speed and reliability needed to meet aggressive timelines.
For the Small Biotech with no internal drug product team, we provide clarity and structure. We become your proactive partner, offering a clear point of contact and structured processes that align with both investor and regulatory needs. We focus on real understanding, not CMC jargon, to ensure you have a solid foundation for your IND/Phase I.
For the Mid-size Biotech needing to break in a new partner, we offer a low-risk entry point. We can tackle a specific challenge, such as lyostability or a new modality, through a pilot project. Our goal is to support your internal drug product teams, not replace them. We deliver results first, then scale our involvement as needed.
For the Pharma company tackling a new modality, we provide the deep technical and modality-specific understanding you need. We can run mini-workshops and deep dives with your team, providing specific insights and data to help win internal buy-in and de-risk your development path.
And for the CDMO looking for a network partner, we function as a seamless, external formulation unit. We handle projects with minimal friction, respecting your client relationships and providing pragmatic, adaptive solutions.
5. Value Provided to Customers
A developability assessment is about creating value by reducing risk. The cost of a failure in late-stage development is enormous, not just in money, but in time. An early, thorough assessment provides confidence.[13, 14]
For leadership and investors, it provides a data-driven path forward. It’s a formulation and development plan designed by science, guided by data, and built for regulatory success.
For fast-moving programs, it delivers speed and substance. It provides hands-on support for rapid development, giving you the structure needed for a successful Phase I.
For teams facing complex problems, it offers reliable, data-driven expertise for overflow or niche challenges. It’s about delivering results you can trust without the internal politics.
For those exploring new areas, it de-risks the journey. It's real data and expertise that guides your path with a tailored formulation design, not a generic template.
For partners, it provides a silent, seamless, and science-backed team that is always loyal to your client relationship.
By integrating developability assessment from the very beginning, you can select the right candidates and build a solid foundation for a successful biologic therapy.
FAQ[2, 6]
1. When is the right time to start a developability assessment?
It should begin as early as possible, during the lead candidate selection phase. Early assessment uses small amounts of material to rapidly screen multiple candidates for potential risks like aggregation or instability.[1, 8, 12] This allows you to select the most promising molecule to move into CMC development.[8]
2. How much material is needed for an initial assessment?[8]
Early-stage assessments are designed to work with microgram to milligram quantities of material. High-throughput and in silico methods are used to maximize the data obtained from a limited supply.[8]
3. What are the most critical parameters to evaluate in a developability assessment?
Key parameters include purity, aggregation propensity, thermal stability, solubility, and potential chemical liabilities like deamidation or oxidation. For high-concentration formulations, viscosity is also a critical factor.[1, 12]
4. How does an AI-powered platform help in formulation development?[15]
AI and machine learning algorithms can analyze complex datasets to predict how a molecule will behave under different conditions. This helps to more efficiently design formulation studies, reducing the number of experiments needed and accelerating the timeline to identify an optimal, stable formulation.[10]
5. How does a good developability assessment impact regulatory interactions?[16, 17]
A thorough assessment forms the foundation of your CMC package. It demonstrates to regulatory agencies like the FDA and EMA that you have a deep understanding of your molecule, its potential critical quality attributes (CQAs), and a strategy to ensure a consistent, stable, and safe product.[18, 19, 9]
