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Directors of CMC face immense pressure developing stable formulations for complex biologics amidst tight timelines. CMC issues frequently cause clinical holds, underscoring the need for robust strategies. Learn how strategic partnerships can de-risk your program.
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The Formulation Challenge: Navigating the Path to Clinic and Market
FAQ
1. Current Situation: A Landscape of Complexity and Urgency
2. Typical Market Trends: Outsourcing, Specialization, and Digitalization
3. Current Challenges and How They Are Solved
5. Value Provided to Customers
The Formulation Challenge: Navigating the Path to Clinic and Market
For Directors of CMC and Drug Product Development, the journey from a promising molecule to a stable, effective, and manufacturable drug product is a road they know well, but it's always changing. The pressure to speed up timelines, combined with more complex molecules, creates a constant need for strong and reliable formulation strategies.
This article looks at drug product development today, highlighting common market trends, challenges, and how a strategic partnership for formulation can make development less risky and really help your program.
1. Current Situation: A Landscape of Complexity and Urgency
The biopharmaceutical pipeline is full of new ideas, from advanced monoclonal antibodies and antibody-drug conjugates (ADCs) to new types of therapies like viral vectors and RNA-based therapies. [1, 24, 25] This variety, while promising for patients, brings big Chemistry, Manufacturing, and Controls (CMC) challenges. In fact, CMC problems are a main reason for clinical holds, with over a third of these delays coming from manufacturing and analytical issues. [3, 33]
For leaders in CMC and drug product development, this means a daily balancing act. The pressure from boards and investors to meet tight deadlines is intense. There's little room for error, and strong doubt towards service providers who don't offer much strategic help is common. Early-stage biotechs, often virtual or with limited in-house lab capacity, really feel this. They need to build a good CMC story for investors and regulatory bodies, often with limited material and tight budgets.
Mid-size and large pharma companies have their own challenges. While they might have internal teams and established partners, they often don't have enough people or time, especially when dealing with new or difficult types of treatments. [20, 4] Bringing new vendors into strict internal buying processes can be a slow and tough process.
2. Typical Market Trends: Outsourcing, Specialization, and Digitalization
Several key trends are shaping how companies approach formulation development:
Strategic Outsourcing: The global market for outsourced formulation development is growing, expected to hit USD 67.7 billion by 2032. [5] Companies are increasingly using specialized partners for their knowledge and technology without the big upfront cost of internal infrastructure. [6] This is especially true for small and mid-sized companies. [6]
Focus on Complex Modalities: More biologics, like cell and gene therapies, ADCs, and viral vectors, are appearing, which means specialized formulation knowledge is needed. [1, 8, 9, 24, 25] These molecules are naturally less stable and harder to handle than traditional small molecules, making formulation a key to success. [1, 24, 25]
The Rise of AI and Predictive Modeling: AI and machine learning are becoming really helpful tools in formulation development. [11, 28] These technologies can predict protein stability, find the best excipients, and speed up finding promising formulations, which cuts down on development time and cost. [11, 13, 26, 27, 28]
Increased Regulatory Scrutiny: Regulatory bodies like the FDA are focusing more on a complete CMC package, even in early development stages. [3, 33] A strong formulation and manufacturing plan is no longer something to worry about late in the process, but a must-have for successful IND and BLA submissions. [3, 18, 33]
3. Current Challenges and How They Are Solved
The path to a stable drug product is full of challenges that need a planned, forward-thinking approach.
Challenge: Limited Bandwidth and In-house Expertise.
Solution: Many biotech companies run with a small team, outsourcing most, if not all, of their lab work. To solve this, they look for partners who can work like part of their team, not just doing the work, but also giving strategic advice. A good partnership involves proactive communication focused on solutions and a clear understanding of the broader development goals.
Challenge: Making Novel and Complex Modalities Less Risky.
Solution: For new therapies like viral vectors or RNA, there's often uncertainty inside the company and no clear best ways of doing things yet. [20, 4] The answer is finding a partner with deep technical knowledge in these specific areas. This often means targeted, smaller projects or pilot studies to check if the partner can do the work and build trust before committing to a larger program.
Challenge: Navigating Complex Internal Processes in Larger Organizations.
Solution: Large pharma companies often have established, sometimes strict, internal processes and preferred vendors. It can be hard to start working with a new partner. The key is to find a specific, urgent need, like a molecule that's hard to make into a drug, a stability problem with an existing product, or not enough capacity, that the current system can't handle. A focused pilot project can show value and clear the way for wider collaboration.
Challenge: The Need for Speed and Efficiency.
Solution: The pressure to get to the Biologics License Application (BLA) quickly is huge. [18] This means you need to optimize many things at once, including cell line, process, and formulation. Using data-driven methods, like AI for stability prediction and Design of Experiments (DoE), is becoming vital to speed things up and make smart decisions faster.
4. How Leukocare Can Support These Challenges
Leukocare is ready to help with these main challenges through a mix of advanced tech, deep scientific know-how, and an approach focused on working together. Our Smart Formulation Platform, which uses AI-based stability prediction, is designed to speed up the development of strong, high-quality formulations. [11, 28]
For the Fast-Track Biotech Leader: We provide a fast, data-driven way to a BLA-ready formulation. Our predictive modeling and customized DoEs let you optimize formulation alongside other CMC activities at the same time, saving valuable time and resources.
For the Small Biotech with Limited Resources: We work as a strategic partner, offering not just data but also the knowledge to understand it. We provide a clear, structured process with proactive communication, helping to build the strong CMC story needed to get funding and regulatory approval.
For the Mid-size Biotech Needing Specialized Support: We offer a way to "break in" by solving specific, complex challenges that your current partners might not be able to handle. Whether it's a new type of therapy, a lyostability issue, or a need for extra capacity, we can deliver results on a pilot project and grow with you as your needs change.
For the Large Pharma Tackling New Modalities: We provide deep technical knowledge for therapies like vectors and ADCs. We offer custom support, from mini-workshops and deep dives to specific insights backed by data that can inform your internal strategy and make development less risky.
For the CDMO Seeking a Formulation Partner: We operate as a neutral, outside formulation unit, so you can offer a full solution to your clients without needing to build an internal team. We work smoothly in the background, making sure projects run smoothly while staying loyal to your client relationship.
5. Value Provided to Customers
The main goal of any formulation development program is to deliver a safe, effective, and stable drug product to patients. By partnering with Leukocare, our customers gain:
Speed and Efficiency: Our data-driven approach, using predictive modeling, helps you reach your development milestones faster.
Making Things Less Risky and More Reliable: We provide the data and knowledge to make smart decisions, making it less risky to avoid expensive delays and failures. We focus on delivering reliable, strong formulations that are built for regulatory success.
A True Partnership: We are more than just a service provider, we are a strategic co-pilot. We work closely with your team, giving proactive solutions and a shared commitment to your program's success.
Confidence and Peace of Mind: Knowing that your formulation is in the hands of dedicated specialists allows you to focus on other important parts of your development program. We provide the structure, speed, and substance to help you succeed.
FAQ
1. What is the biggest challenge in drug product formulation today?
The increasing complexity of biologic drugs is a big challenge. [22, 23] Many new molecules, such as ADCs and viral vectors, are naturally unstable and require highly specialized formulation strategies to ensure they are safe, effective, and have an adequate shelf life.
2. How is AI changing formulation development?
AI and machine learning are changing formulation from guesswork to a science you can predict. [3, 13, 16, 26, 27] These tools can look at huge amounts of data to predict which excipients will best stabilize a molecule, really speeding up development timelines and reducing the amount of costly drug substance needed for testing.
3. What should I look for in a formulation development partner?
Look for a partner that offers more than just capacity. [29, 30, 32] A true strategic partner will have deep scientific knowledge in your specific type of molecule, a data-driven approach to development, and a desire to work together. [29, 32] They should act as an extension of your team, providing proactive solutions and clear communication.
4. How early in the development process should I start thinking about formulation?
As early as possible. It's important to start thinking about formulation and CMC planning during preclinical development. [3, 16, 27, 33] Early attention to formulation can prevent expensive delays down the road, as a stable, manufacturable drug product is a key requirement for both investors and regulatory agencies.
5. How can a strong formulation strategy help with fundraising?
Investors are increasingly looking closely at the CMC package of potential investments. [3, 33] A well-defined, data-driven formulation strategy shows that you have made a key part of development less risky. It shows that you are not just focused on the science but also have a clear plan to turn your molecule into a workable product, which can significantly increase investor confidence. [34]
