how-to-manage-heterogeneity-in-bsab-products
Modern biologics, including bsAb products, bring increasing formulation complexity. Managing their inherent heterogeneity is critical for stability and market success. Discover strategic insights to navigate these development hurdles effectively.
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Navigating the Formulation Maze: A Strategic Approach for Modern Biologics
Frequently Asked Questions (FAQ)
The Evolving Landscape of Drug Development
Common Hurdles in Drug Product Development and How to Clear Them
How Leukocare Can Support These Challenges
What We Offer Customers
Navigating the Formulation Maze: A Strategic Approach for Modern Biologics
The biopharmaceutical market is growing, with projections showing its value could reach over $740 billion by 2030.[1, 2] This expansion isn't just about volume; it's also about complexity. We're seeing a move toward more intricate molecules, from monoclonal antibodies to entirely new types like viral vectors and RNA-based therapies. For leaders in Chemistry, Manufacturing, and Controls (CMC) and Drug Product Development, this brings both opportunity and a fair share of challenges.
Developing a drug is a long, costly road. Success often hinges on getting the formulation right. A stable, effective, and scalable formulation can be the difference between a promising molecule and a successful product. But achieving that is rarely straightforward.
The Evolving Landscape of Drug Development
A few trends are shaping how we approach drug development in 2025. The rise of biologics continues to be a major factor, with monoclonal antibodies making up a large part of the market. At the same time, companies are exploring new frontiers with cell and gene therapies, which require entirely new manufacturing and formulation strategies.[6]
Outsourcing has become a common practice, with the formulation development outsourcing market expected to grow a lot.[7, 11] Companies, especially smaller biotechs, count on contract development and manufacturing organizations (CDMOs) to provide specialized know-how and facilities.[9, 10, 11] This allows them to manage costs and speed up timelines.[12]
Digital tools are also becoming more part of the development process. Artificial intelligence and machine learning are now being used to predict formulation stability and make development better, moving the industry away from traditional trial-and-error methods.[14, 15] This data-driven approach helps to make development faster and more precise.[18, 28]
Common Hurdles in Drug Product Development and How to Clear Them
Every drug development leader faces a familiar set of challenges. Getting ahead means understanding these hurdles and having a plan to address them.
Challenge 1: Ensuring Stability and Quality
Biologics are naturally unstable.[19] Degradation and aggregation are constant risks that can make a drug less safe and effective.[20] These issues can show up at any stage, from development and manufacturing to transport and storage.[20] The pressure to develop high-concentration formulations for subcutaneous injection adds another layer of complexity, often increasing issues with viscosity and protein aggregation.[21, 22]
How it's solved: The solution lies in a deep understanding of the molecule and the factors that affect its stability.[19] This involves stress testing under various conditions to identify potential degradation pathways.[20] This data informs the selection of excipients and process parameters to create a stable formulation. Early and thorough characterization is key to building a robust CMC story for investors and regulators.
Challenge 2: Navigating the Path to Clinic and Market
For a fast-track biotech, the main goal is to get to the Biologics License Application (BLA) quickly and efficiently. This means making the cell line, process, and formulation as good as possible in parallel. For a small, virtual biotech with no internal lab, the challenge is managing a network of external partners to move from seed funding to an Investigational New Drug (IND) application. These companies need partners who can not only execute but also think proactively.
How it's solved: Success requires a well-defined strategy and a reliable network of partners. Outsourcing to a CDMO with a good track record can provide the necessary expertise and resources.[7, 11, 12] Clear communication and a collaborative approach are important to keep development on track. Also, establishing a clear change control process can avoid unexpected costs and delays.[23]
Challenge 3: Scaling and Integrating New Partners
Mid-size biotechs with established pipelines often don't have enough people or time. Their internal teams and existing service partners may be full, especially when dealing with new or difficult types of drugs. Onboarding new vendors through procurement can be a slow and annoying process.
How it's solved: These companies need flexible solutions that can be used without messing up existing workflows. A pilot project focused on a specific problem, like how stable a freeze-dried product is or a new type of drug, can be a good way to test a new partner. This allows the company to bring in specialized expertise for specific problems without committing to a big, long-term project.
Challenge 4: Tackling New and Unfamiliar Modalities
Large pharmaceutical companies have lots of internal resources, but they may lack experience with newer types of drugs like viral vectors or RNA. This can lead to unsureness how to plan their drug product and mean they lack certain skills.
How it's solved: Working with specialized partners is often the answer. These partners can provide targeted support, such as deep technical know-how on vectors or ADCs, and help the internal team learn on their own. This might involve mini-workshops, tailored educational materials, or simply having a trusted advisor for modality-specific questions.[24]
Challenge 5: The CDMO's Formulation Problem
Many CDMOs offer services like drug substance manufacturing and fill-finish, but not formulation development. When their clients ask for it, they want to provide a full-service experience without building an internal formulation team. This creates a need for a neutral, external formulation partner who can be smoothly brought in to their projects.
How it's solved: CDMOs can partner with specialized formulation providers. This allows them to offer a complete service package to their clients without the investment and overhead of an in-house team. The key is to find a partner who can work quietly and dependably, working like an extension of the CDMO's own team and respecting the existing client relationship.
How Leukocare Can Support These Challenges
At Leukocare, we've designed our services to solve these common industry problems. We work as a strategic partner, providing formulation solutions that are made for the unique needs of each client.
For the Fast-Track Biotech Leader, our Smart Formulation Platform and AI-based stability prediction offer a faster, data-driven way to get a strong, commercial-ready formulation. We work as a strategic co-pilot, providing the top science and regulatory knowledge needed to move quickly and confidently toward BLA.
For the Small Biotech with CMC Understanding, we communicate clearly and proactively, and have organized processes. We work like an extension of their team, handling the work and giving data-backed results needed to create a strong CMC story for investors and get to the IND/Phase I stage safely.
For the Mid-size Biotech, we offer a way to "break in" without big disruption. We can start with a pilot project focused on a specific problem, showing our value by getting results first. We support internal drug product teams, we don't replace them.
For the Pharma Company Tackling a New Modality, we offer deep technical knowledge in areas like viral vectors and ADCs. We provide specific insights and training to help their teams build confidence and make good regulatory decisions.
For the CDMO as a Network Partner, we offer a smooth, quiet formulation service. We handle projects independently, communicate clearly, and remain loyal to the CDMO's client relationship, allowing them to offer a full-service solution.
What We Offer Customers
Our goal is to provide more than just data. We offer a path to a stable, effective, and scalable drug product.
For biotech leaders, we give you a data-driven formulation that helps with regulatory success, helping you reach your BLA faster.
For small biotechs, we offer structure, speed, and real help, providing the reliable data and hands-on support needed for a successful path to Phase I.
For mid-size biotechs, we offer reliable expertise to solve tough problems, allowing you to focus on your core pipeline.
For large pharma, we help you with new types of drugs using real data and custom formulation design, helping you make development less risky.
For CDMOs, we work as your quiet, smooth, and science-backed formulation team, always loyal to your client relationship.
By understanding the unique challenges of each company, we can provide the right support to help bring new therapies to patients safely and quickly.
Frequently Asked Questions (FAQ)
Q1: At what stage should I start thinking about formulation development?
It's a good idea to think about formulation from the early stages of development. Early formulation work can identify potential stability issues and inform process development, which can save you from expensive delays later. For investigational drugs, the FDA expects manufacturing processes to be clear as you move into Phase II studies.
Q2: How does outsourcing formulation development help my company?
Outsourcing gives you access to specialized know-how and advanced tech without the need for big upfront costs. It can help you speed up timelines, reduce risks from formulation failure, and allow your internal team to focus on their main research and development activities.[7, 11, 25]
Q3: We are working with a new modality (e.g., viral vector, RNA). What are the specific formulation challenges?
New types of drugs often come with special stability and delivery challenges. Viral vectors, for example, can be sensitive to their environment, and maintaining their infectivity and stability during manufacturing and storage is critical.[26, 27] RNA is also really unstable. A specialized partner can provide the necessary expertise to develop a strong formulation and delivery plan for these complex products.[12, 24]
Q4: How can AI and predictive models improve my formulation development process?
AI and predictive models can analyze large datasets to find patterns and guess how different ingredients will affect a drug's stability and performance.[14, 15] This can really speed up the formulation process by needing fewer experiments and helping to find the best formulation more quickly.[18, 28]
Q5: We are a CDMO that doesn't offer formulation services. How can a partnership with a formulation specialist benefit us?
Partnering with a specialized formulation provider allows you to offer a more complete service package to your clients. This can help with keeping clients and provide an easier project experience. By bringing in a neutral, external partner, you can meet your clients' formulation needs without the expense and hassle of building an in-house team.[11]
