biopharmaceutical-contract-development
Bringing a new biologic to market involves complex formulation challenges. Discover current trends, hurdles, and how biopharmaceutical contract development partners can ensure stable, effective drug products.
Menu
Current Situation
Typical Market Trends
Current Challenges and How They Are Solved
How Leukocare Can Support These Challenges
Value Provided to Customers
FAQ
The Art and Science of Formulation: A Guide for CMC and Drug Product Leaders
Formulation development is key to bringing a new biologic to market. It's also super complex. For leaders in CMC and Drug Product Development, getting a promising molecule to be a stable, effective, and manufacturable drug product has lots of challenges. This article looks at biopharmaceutical formulation today, its trends, the hurdles you face, and how a dedicated formulation partner can help you succeed.
Current Situation
The biopharmaceutical market is growing, with a projected value of over $965 billion by 2034.[1] This growth is driven by complex therapies like monoclonal antibodies, vaccines, and cell and gene therapies.[2] These new treatments offer hope for patients with chronic and rare diseases, but their complexity means unique formulation challenges.
Biologics are molecules that aren't stable.[15, 16, 3] They are sensitive to their environment. Things like temperature, pH, and how they're handled can make them degrade, clump together, or stop working.[3, 4, 5, 15, 16]
Typical Market Trends
Biologics are getting more complex, and that's driving several market trends. New things like mRNA and viral vectors bring new formulation challenges that need special know-how.[6, 7] People also want easier ways to get medicines, like shots under the skin. Those need high-concentration formulations that can be tough to make.[8]
Lots of companies are outsourcing their formulation work to CDMOs because they need special expertise and want to cut costs and speed things up.[10, 9] The global CDMO market should hit almost $489 billion by 2034. This shows how much companies rely on these partners.[11]
Current Challenges and How They Are Solved
Formulation development teams have a few challenges:
Stability: Biologics can degrade, affecting their safety and how well they work.[4, 5] Making sure they stay stable long-term is a main worry.
High Concentration: Making high-concentration formulations for shots under the skin can cause problems with thickness and clumping.[15, 16, 3]
New Modalities: mRNA, viral vectors, and other new therapies have unique stability and delivery issues that need special formulation methods.[6, 7] For instance, mRNA vaccines don't like temperature changes and need specific lipid nanoparticle formulations for delivery.[13]
Regulatory Scrutiny: Regulators demand lots of data to show a drug's safety, effectiveness, and quality. This means detailed info on the formulation and manufacturing process.[14]
To solve these, companies are using advanced formulation tech and strategies. This includes new excipients for better stability, advanced analytical methods to understand the drug product, and AI and machine learning to predict the best formulations.[15, 16, 3]
How Leukocare Can Support These Challenges
Leukocare is a special formulation development partner that can help you handle the complexities of getting a new biologic to market. Our team is really experienced at stabilizing many biologics, from standard proteins to new things like mRNA and viral vectors.[17]
We use a smart, data-driven approach to formulation, mixing our deep knowledge of protein chemistry with advanced analytical methods and AI. Our Stabilizing and Protecting Solutions (SPS®) platform helps us make custom formulations that keep your drug product from degrading and make sure it stays stable its whole shelf life.[17]
Value Provided to Customers
Partnering with Leukocare helps you:
Lower your development risks: Our expertise in formulation development can help you avoid costly delays and setbacks.
Speed up your timeline: Our efficient and data-driven approach can help you get to the clinic and to the market faster.
Make your product better: Our innovative formulation solutions can help you develop a more stable, effective, and patient-friendly drug product.
Get specialized expertise: Our team of formulation scientists has a deep understanding of the challenges of developing complex biologics.
FAQ
What is the most important factor in formulation development?
There's no single "most important" factor. Formulation development involves many things. You need to really understand the drug, what it's for, and the rules. But making sure the biologic is stable is a top priority.
How can I ensure my formulation is manufacturable?
Think about manufacturability right from the start of formulation development. This means picking excipients that are easy to get and work with standard manufacturing processes. Partnering with an experienced team can help you avoid manufacturing problems later on.
What are the key considerations for outsourcing formulation development?
When picking a CDMO, find a partner with a proven history of successfully formulating biologics. Look for a team with strong scientific knowledge, a collaborative style, and a focus on quality. Make sure the CDMO also has the right analytical tools and manufacturing capacity for your project.
