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The biopharmaceutical landscape is rapidly evolving, putting immense pressure on drug development teams to innovate faster. Discover how high-throughput screening for bsAb formulations can streamline development and address complex challenges. Read more to navigate this high-stakes environment effectively.
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Navigating the Evolving Landscape of Biopharmaceutical Formulation
FAQ
1. Current Situation: A High-Stakes Environment
2. Typical Market Trends: Outsourcing and Specialization
3. Current Challenges and How They Are Solved
4. How Leukocare Can Support These Challenges
5. Value Provided to Customers
Navigating the Evolving Landscape of Biopharmaceutical Formulation
The biopharmaceutical world is always changing. As we move through 2025, drug development teams, especially those in Chemistry, Manufacturing, and Controls (CMC) and Drug Product (DP) development, are facing more pressure than ever. There's a big demand for new therapies, but getting them to market is also getting more complicated. This article looks at biopharmaceutical formulation now, what's trending, the problems teams are dealing with, and how working with the right partners can help.
1. Current Situation: A High-Stakes Environment
Biopharmaceutical companies are dealing with a tough situation. The global biopharmaceutical market is expected to grow a lot, hitting about USD 921.5 billion by 2034, up from USD 422.5 billion in 2024. [1] This growth comes from a rising demand for biologics, specific therapies, and treatments for long-term and rare illnesses. [1]
This big opportunity also comes with a lot of pressure. Venture capital funding in biotech is harder to get, as investors are looking more for companies further along that can show a clear way to sell their products. [2, 3, 4] This change really pushes early and mid-stage biotechs to make their projects safer and show real progress. The drive for faster development, thanks to things like the FDA's Fast Track designation, makes things even more urgent. [5]
2. Typical Market Trends: Outsourcing and Specialization
Because of these pressures, a few big trends are changing the market.
Increased Outsourcing: The outsourcing of formulation development is on the rise. The global market for formulation development outsourcing is expected to grow from USD 37.3 billion in 2024 to over USD 60.6 billion by 2030. [6] Companies are using contract development and manufacturing organizations (CDMOs) more and more to get special know-how and tech, cut costs, and speed things up. [5] This is especially true for small and mid-sized biotech companies that might not have enough internal resources for a lot of in-house CMC work. [5]
Focus on Complex Modalities: The industry is seeing a lot more complex drug types like viral vectors, cell and gene therapies, and RNA-based treatments. [10, 9] These new therapies come with unique challenges for formulation, like making sure they're stable, handling high concentrations, and creating good delivery systems. [10, 11, 12] Making these products is often complicated and not standardized, so it needs special knowledge and adaptable manufacturing setups. [10, 12]
The Rise of AI and Predictive Modeling: Artificial intelligence and machine learning are being used more and more in drug development. [14] These technologies can look at huge amounts of data to guess formulation properties, make stability better, and speed up development. [16, 17] AI tools can help find good formulations that are more likely to work, cutting down on the need for many expensive physical tests. [14]
3. Current Challenges and How They Are Solved
Getting a biologic formulation that's stable and works well is usually tricky. Development teams run into a lot of problems:
Stability and Degradation: Biologics are naturally less stable than small molecule drugs and can break down because of things like temperature changes and manufacturing stress. [19, 20, 21, 26] This can cause them to clump up, lose strength, and potentially create safety problems. [11, 20] Lyophilization, also called freeze-drying, is a common way to make biologics more stable and last longer, especially for sensitive molecules like proteins, vaccines, and cell therapies. [22, 24]
High Concentration Formulations: For many treatments, especially monoclonal antibodies, we need formulations with high concentrations so they can be injected under the skin. [11] This creates issues with how thick they are, clumping, and keeping them stable at high concentrations. [11] Creating formulations that are stable, not too thick for injection, and can be given in a small amount is a big challenge. [11]
Navigating Regulatory Complexity: The rules for biologics are always changing. [25] Making sure all parts of manufacturing and quality control meet strict standards is super important to avoid delays. [25] For new types of therapies like cell and gene therapies, the rules can be less clear, making things even trickier. [25]
Resource Constraints and Internal Bandwidth: Development teams often don't have enough internal staff or time. This is particularly true for smaller biotech companies that are running on limited resources. Poor experiences with academic-style contract research organizations (CROs) that aren't quick enough can make resources and timelines even tighter.
4. How Leukocare Can Support These Challenges
This is where having a dedicated formulation partner can really help. At Leukocare, we get the pressures and complicated parts of drug product development. We work as an extension of your team, giving smart advice and hands-on help to find your way to a great formulation.
We tackle stability and degradation problems with our Smart Formulation Platform. It mixes data-driven predictions with our deep knowledge of formulation science. This lets us create custom formulations made for stability and easy approval. For tricky stuff like viral vectors and ADCs, we bring special know-how to make development less risky and help with your internal decisions.
We know flexibility is key, so we have solutions for companies at any stage. If you're a virtual biotech rushing to get to the BLA, we offer a fast, reliable, and smart partnership. If you're a mid-size biotech facing internal slowdowns, we can jump in to fix specific problems without messing up your current work. We're proud of our clear, problem-solving communication and our reliable results.
5. Value Provided to Customers
We want to give you more than just data; we give you a clear way forward. We help our clients get:
Data-driven decision-making: Our predictive modeling and formulation intelligence provide the insights needed to make informed decisions and build a robust CMC story for investors and regulators.
Accelerated timelines: By getting the formulation right the first time, we help you reach clinical milestones and the BLA faster.
Reduced risk: Our expertise in both formulation science and regulatory requirements helps to de-risk your development program.
A true partnership: We work as a strategic co-pilot, offering proactive solutions and a hands-on approach to move your project forward.
For CDMOs, we work as a neutral, behind-the-scenes formulation partner. This lets you offer complete solutions to your clients without having to invest in your own formulation setup. We make sure projects run smoothly and easily, which helps build stronger client relationships.
Developing biopharmaceuticals is tough, but with the right partners, you can handle the complexities and bring life-changing treatments to patients.
FAQ
What does a formulation partner do in drug development?
A formulation partner brings special know-how to create a drug product that's stable, works well, and can be made. This covers everything from early studies to making the final freeze-dried or liquid version for clinical trials and selling. A good partner helps you plan things out and guides you through technical and regulatory hurdles.
How is formulation for biologics different from small molecules?
Biologics are big, complicated molecules from living things, so they're naturally less stable than small molecules made with chemicals. [21, 26] They're sensitive to their surroundings and can break down or clump if not formulated right. [20] This means you need a deep understanding of protein chemistry, how to keep things stable, and how making the product affects the final result. [26]
Why is lyophilization important for biologics?
Lyophilization, or freeze-drying, takes water out of the product at low temperatures, leaving a stable, dry powder you can mix with liquid later. [22, 24] This process is super important for many biologics that aren't stable as a liquid for a long time, because it helps keep their structure and activity, making them last longer. [22, 24]
What are the key considerations for outsourcing formulation development?
When you're looking for an outsourced formulation partner, find one with a good history, expertise in your type of drug, and a team-player, problem-solving mindset. Good communication, a focus on meeting rules, and being able to guide you strategically are all super important for a good partnership.
How can AI and predictive modeling help in formulation development?
AI and predictive modeling can look at huge amounts of data to spot patterns and guess how different formulations will act. [16, 17] This can help you check more options and find the best formulations for testing, saving time and money. [14] It means a more data-focused and efficient way to design formulations. [14]
