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The journey of biologic formulation is increasingly complex, especially for advanced formats like bispecific antibodies. Discover how strategic use of thermal shift assays for bsAb formulation screening can optimize stability and accelerate drug product development. Learn to navigate market trends and overcome key challenges.
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The Changing Face of Biologic Formulation: A Guide for CMC and Drug Product Leaders
1. Current Situation
2. Typical Market Trends
3. Current Challenges and How They Are Solved
4. How Leukocare Can Support These Challenges
5. Value Provided to Customers
6. FAQ
The Changing Face of Biologic Formulation: A Guide for CMC and Drug Product Leaders
Getting a biologic from the lab to a patient is a long, complicated journey. If you're leading Chemistry, Manufacturing, and Controls (CMC) or drug product development, things are always changing. New biologic formats, evolving regulatory expectations, and market pressures create a demanding environment. We'll look at the current state of biologic development, market trends, and how a smart approach to formulation can tackle key challenges.
1. Current Situation
There's a lot of new stuff happening in biologic drug development. Clinical trials for biologics are growing faster than for small molecule drugs, showing how complicated this area is getting. This is happening because we understand diseases better and see the potential of new treatments like antibody-drug conjugates (ADCs), cell and gene therapies, and RNA-based treatments.[16, 2, 38] These advanced therapies bring their own tough manufacturing and stability problems.[16, 2, 38]
Biotech investment is picking up in 2024, with lots of money going to companies developing exciting new tech.[5, 6, 7] This extra cash means R&D is moving faster, pushing CMC and drug product teams to work even quicker.
2. Typical Market Trends
Here are some big trends in biologic development:
Outsourcing is on the rise: To save money and get specialized help, more pharmaceutical companies are working with contract development and manufacturing organizations (CDMOs).[9, 11, 12, 33, 34] This lets them concentrate on their main research and marketing, while external partners handle the rest.[12, 9]
The growth of complex biologics: We're seeing many more complex biologics being developed, and they need advanced ways to formulate and make them.[16, 2, 38] The global biologics market is expected to hit $900 billion by 2030, which shows strong, ongoing demand.[13]
A focus on patient-friendly formulations: Companies are focusing more on making formulations that are easier for patients, like self-administered injections or oral biologics.[16, 2, 38]
The rise of biosimilars: More biosimilars getting approved means more competition and lower prices in the market.[2, 15, 16, 38] In 2024, the FDA approved a record number of biosimilars, a trend that is expected to continue.[15]
Technological advancements: New bioprocessing tech, like single-use systems and continuous manufacturing, is making things more efficient and cheaper. Artificial intelligence (AI) is also helping to make drug discovery and formulation development better.[17, 18, 19]
3. Current Challenges and How They Are Solved
Developing biologics comes with its own set of challenges. Here are some common problems and how people are solving them:
Instability of Biologics: Biologic drugs often aren't very stable and can break down, which impacts how safe and effective they are. Getting the formulation right early on is super important here.[23, 25] By picking the right buffers, pH levels, and other ingredients, scientists can create a stable home for the drug.
Complex Manufacturing: Making biologics, especially advanced treatments like viral vectors and RNA, is super complex and needs expert knowledge.[16, 2, 38] Working with a CDMO experienced in these areas can help you deal with these tricky parts.[11, 33, 34]
Regulatory Hurdles: The rules for biologics are always changing, making it tough to stay updated.[16, 2, 38] You need a clear regulatory plan and good communication with agencies to get your IND and BLA submissions approved.[38, 39, 40]
New Modalities: New kinds of treatments, like viral vectors and RNA therapies, have their own formulation problems.[30, 41, 42] For instance, viral vectors need specific formulations to stay intact when stored, and RNA delivery systems must protect the delicate RNA molecule from breaking down.[30, 41, 42]
4. How Leukocare Can Support These Challenges
Leukocare has a unique way to develop formulations that can help with these problems. We combine our special formulation tech platform with advanced bioinformatics. This lets us create stable, effective formulations for all sorts of biologics.
We start by really understanding what's challenging about each project. We team up with our clients to figure out their goals and create a custom formulation plan. Our AI helps us predict and fix potential stability issues early on, which saves time and lowers risk.
5. Value Provided to Customers
When biotech and pharma companies work with Leukocare, they get:
A faster path to market: Our efficient formulation process can speed up your IND and BLA submissions.
Reduced risk: Our predictive modeling and data-driven approach help us find and fix potential formulation problems early, cutting down on expensive delays.
Improved product quality: We focus on stable, effective formulations, which helps ensure the final drug product is high quality and consistent.
A collaborative partnership: We act like an extension of our clients' teams, offering great communication and support during the whole development process.
6. FAQ
Q: What's the most important thing in biologic formulation?
A: The most important thing is making sure the biologic drug is stable. Biologics are sensitive to their surroundings, so a good formulation is essential to keep them working right.
Q: When should you start developing the formulation?
A: You should start formulation development as early as you can in the drug development process.[23, 25] Early formulation work can help spot potential stability problems and guide you to pick the best drug candidates.[23, 25]
Q: How can I be sure my formulation will meet regulatory rules?
A: You need to really understand the regulatory guidelines and be proactive about fixing potential issues.[16, 2, 38] Working with an experienced formulation developer can also help you deal with the regulatory scene.
Q: What should you think about when formulating new treatments like viral vectors and RNA therapies?
A: These advanced treatments have special formulation needs. Viral vectors need specific conditions to stay structured and infectious, while RNA delivery systems must protect the delicate RNA molecule.[30, 41, 42]
Q: How is AI changing formulation development?
A: AI is being used to look at huge amounts of data and predict how stable different formulations will be.[17, 18, 19] This can help speed up development and find the most promising formulations faster.[17, 18, 19]
