formulation-for-novel-biologics
The biopharmaceutical market is booming, but increasingly complex novel biologics present immense challenges for CMC and Drug Product leaders. Discover how rethinking formulation for novel biologics can accelerate your pipeline, reduce risk, and navigate tight budgets.
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Frequently Asked Questions (FAQ)
The Shifting Ground for CMC Leaders
Common Hurdles and How They Are Being Addressed
The Value We Provide
Beyond the Order Taker: Rethinking Formulation in Modern Drug Development
The biopharmaceutical market is growing, with projections showing it could reach over $740 billion by 2030.[1, 2] This growth isn’t just about volume; it's fueled by increasingly complex molecules, from monoclonal antibodies to viral vectors and RNA therapies. For Chemistry, Manufacturing, and Controls (CMC) and Drug Product (DP) leaders, the goal is clear but tough: move these complex drug candidates through the pipeline faster, with less risk, and on tighter budgets.[3]
The pressure is immense. You're not just developing a drug; you're building a strong CMC story that will impress regulators and investors. This needs more than just a service provider who follows instructions. It needs a strategic partner who can anticipate challenges and contribute to the solution.[25, 4]
The Shifting Ground for CMC Leaders
Several market trends are changing things for drug product development. The rise of biologics, which now have a better chance of approval than small molecules, has brought new stability and manufacturing challenges.[5] At the same time, a tight funding environment, especially for early-stage companies, means there is little room for error. Nearly a third of biotechs may not have enough cash to sustain operations for more than a year, so success is crucial for them to stay afloat.[6, 7]
This environment has led to a heavy reliance on outsourcing.[7] The formulation development outsourcing market was valued at over $37 billion in 2024 and continues to grow. Companies increasingly partner with contract development and manufacturing organizations (CDMOs) to access specialized skills and manage costs.[8] This also brings challenges, like managing many vendors and making sure your partner really gets the science behind your molecule.[10, 9]
Common Hurdles and How They Are Being Addressed
For Directors of CMC and Drug Product, the day-to-day challenges are extensions of these larger trends.
The Stability Puzzle with Complex Molecules: New modalities like viral vectors and RNA are often fragile. Ensuring their stability throughout manufacturing and shelf-life is a big challenge.[11, 12] Normal formulation methods often don't work, requiring a really deep understanding of degradation pathways and the right combination of excipients.[13, 14] Lyophilization is a common solution for improving stability, but developing a successful freeze-drying cycle is a tricky science.
The Black Box of Outsourcing: Many teams have experienced partnerships with service providers who don't share much information.[15, 16] Communication is reactive, you get generic solutions, and they don't offer strategic advice. This causes problems and risk, especially when you need a partner to think proactively and help build a good regulatory submission. Successful teams solve this by seeking more open and collaborative partnerships where the CDMO acts as an extension of their internal team.[25, 4]
Pressure to Move Faster with Fewer Resources: In a tough funding climate, the goal is to hit clinical goals fast and well.[18, 19] This means you can't afford to waste valuable material on experiments that don't go anywhere.[20, 21] The solution lies in smarter development. Forward-thinking teams are using data-driven approaches and predictive modeling to design more targeted experiments, cutting down the time and material needed to find a working formulation.
How Leukocare Can Support These Challenges[22, 23]
We built our approach to address these specific pressures. We see formulation not as just another service, but as a critical, strategic function that can make your whole program less risky. Our goal is to be the co-strategist our partners need, not just someone who follows orders.
We do this in a few key ways:
First, we use our Smart Formulation Platform, which combines lots of scientific smarts with AI for predicting things. This allows us to predict stability really accurately.[24] Instead of relying on trial and error, we can smartly plan experiments that get to a strong, scalable formulation faster. For you, this means less material wasted and a clearer, data-guided path forward.
Second, we focus on true collaboration. Our teams work at eye-level with your CMC experts. We bring our own opinion to the table, backed by data and experience with a wide range of modalities, including viral vectors, ADCs, and RNA. We provide the specific ideas and examples needed to help you make decisions internally and build confidence with your board and investors.
Finally, we offer flexibility for every stage. For a virtual biotech moving at top speed, we provide a fast, clean path to a BLA-ready formulation. For a mid-size company facing a specific challenge like lyostability, we can enter as specialists to solve a niche problem and show our worth with a pilot project. For CDMOs, we act as a neutral, quiet formulation team, helping them offer complete service solutions without extra internal costs.
The Value We Provide
Our approach means real results for our customers. The core value is confidence: confidence that your formulation is built on solid science, that your timelines are possible, and that your regulatory submission is backed by strong data.
We provide:
Speed and Efficiency: By using predictive data, we cut down on the experiments needed, helping you reach IND or BLA faster.
Reduced Risk: A stable, well-characterized formulation is key for clinical success. We help you get it right early, reducing later risks.
Strategic Support: We deliver more than just data; we provide the organized documents and clear communication needed to help with investor updates and regulatory filings.
Our work is about giving you structure, speed, and substance.[25, 4] We deliver reliable, data-driven results you can trust, allowing your team to focus on the bigger picture of bringing a new therapy to patients.
Frequently Asked Questions (FAQ)
1. We are a virtual company and need to get to BLA as fast as possible. How do you help with that?
We specialize in speeding up timelines for fast-track programs. Our AI-powered platform predicts stability and helps plan efficient experiments, providing a quicker, cleaner path to a formulation ready for regulators. We act as your strategic partner, making all CMC parts work together at the same time to meet tough board expectations.
2. We already have established CDMO partners. How would you fit in?
We often work with companies that have existing partners. We can be brought in for specific, difficult challenges where your current vendors have hit a limit, such as a new modality or a lyostability issue. We can run a pilot project to show what we can do, supporting your internal DP teams without replacing or overriding them.
3. Our molecule is a new type of molecule (e.g., viral vector, RNA). Do you have experience with that?
Yes, we have a lot of experience in formulating complex biologics, including viral vectors, ADCs, and RNA-based therapeutics. We understand the special stability problems these molecules present and customize our formulation strategies to address them, going beyond standard, off-the-shelf answers.
4. How do we know you won't just act like another academic CRO?
Our focus is on real-world, solution-focused results, not just studying things. We provide clear, short communication and organized, reliable data that investors and regulators need. We understand the pressure to build a strong CMC story and avoid getting stuck in never-ending development.
5. We are a CDMO that doesn't offer formulation. Can you work with our clients?
Absolutely. We partner with CDMOs to act as their neutral, outside formulation team. We handle the formulation development smoothly and quietly, allowing you to offer a complete service package to your clients. We are loyal to the CDMO relationship and won't try to steal your clients.
