viscosity-prediction-models-for-bispecific-antibodies
The journey to a life-changing biologic therapy is complex, often stalled by formulation hurdles like high viscosity. Learn how innovative viscosity prediction models for bispecific antibodies can stabilize development, cut costs, and accelerate market entry. Explore solutions for modern biologics.
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Stabilizing the Future: Navigating Formulation in Modern Biologics Development
Current Situation: A Growing and Complex Pipeline
Typical Market Trends
Current Challenges and How They Are Solved
How Leukocare Can Support These Challenges
Value Provided to Customers
FAQ
Stabilizing the Future: Navigating Formulation in Modern Biologics Development
Getting a biologic from a promising molecule to a life-changing therapy is a long and complex journey. For leaders in CMC and drug product development, the path has scientific, regulatory, and logistical hurdles. Formulation, the science of creating a stable and effective drug product, is a critical part of this journey. [2] A well-designed formulation can mean the difference between a successful product and a candidate that never reaches patients. [1, 3] This article explores the current landscape of biologic development, common challenges in formulation, and how new approaches are helping to bring these therapies to market faster.
Current Situation: A Growing and Complex Pipeline
The biologics market is growing fast, with its global market size expected to reach over $1 trillion by 2033, up from $471.9 billion in 2024. [4] This growth comes from the demand for targeted therapies for complex conditions like cancer and autoimmune disorders. [4] As a result, drug development pipelines are filled with increasingly complex molecules, from monoclonal antibodies to new modalities like viral vectors and mRNA-based therapies. [6]
This complexity creates new challenges. Many new drug candidates are hard to formulate because of poor solubility or stability. In fact, up to 70% of drugs in development are poorly soluble. Developing a new drug already takes a long time, typically 10 to 15 years, with costs that can go over $2.6 billion. [8, 9] Formulation challenges can extend these timelines and costs, sometimes leading to promising candidates being abandoned.
Typical Market Trends
Several key trends are shaping the biopharma world:
More companies are outsourcing. To manage costs and get specialized skills, many biopharma companies are outsourcing parts of drug development to contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs). [10] The global biopharmaceutical outsourcing market is expected to grow, showing this trend. [10] In 2023, 84.6% of biomanufacturers reported outsourcing analytical testing. [12]
New types of therapies bring new complexities. The increase in viral vectors and RNA-based therapies creates new manufacturing and formulation challenges. [13] These molecules are often less stable and need specific delivery systems. [13]
AI and predictive modeling are becoming more popular. Artificial intelligence and machine learning help speed up drug discovery and formulation development. [16, 17, 18] These technologies can predict which formulations will likely work best, cutting down on extensive trial-and-error experiments. This can make development faster and cheaper. [17]
Regulatory expectations are changing. Regulatory agencies like the FDA and EMA have strict rules for product quality, safety, and effectiveness. [19, 20] As new types of therapies come out, these agencies are changing their guidelines, so developers need to keep up with the latest rules. [21]
Current Challenges and How They Are Solved
CMC and drug product leaders deal with several common formulation challenges:
Ensuring Stability: Biologics are big, complex molecules that can easily degrade if not formulated right. [22] This degradation can happen because of things like temperature, pH, and the manufacturing process itself. [2, 22] To handle this, formulation teams do extensive stress testing to find the most stable combination of a drug and its inactive ingredients, called excipients. [23]
Dealing with New Modalities: Viral vectors and mRNA therapies have unique stability and delivery challenges. [13] For example, mRNA is notoriously unstable and requires a protective delivery vehicle, like lipid nanoparticles. [13] Solving these issues needs specialized knowledge and technologies.
Accelerating Timelines: There's huge pressure to get new drugs to market fast. [25] Traditional formulation development can slow things down. [17] To speed things up, companies are using high-throughput screening and predictive modeling. [26]
Working with Limited Material: Early in development, there's often limited drug substance available. This makes it hard to do all the testing needed for formulation development. Predictive modeling and smaller-scale experiments can help make the most of what's available.
How Leukocare Can Support These Challenges
Leukocare helps biopharmaceutical companies with these formulation challenges. Our approach is based on a deep understanding of protein chemistry and using advanced tech to design stable and effective drug products.
We combine predictive modeling and high-throughput screening to quickly find the best formulation strategy for a given molecule. Our AI-based platform can predict protein stability, helping guide the selection of excipients and processing conditions. [27, 28, 29] This data-driven approach means we can develop strong formulations with less time and material than traditional methods.
We also have experience with many types of biologics, including monoclonal antibodies, viral vectors, and other complex proteins. [6] This means we can provide custom solutions for the unique challenges each type of molecule brings. By partnering with us, companies can reduce risks in their development programs and speed up their path to the clinic.
Value Provided to Customers
When partners work with Leukocare, they can:
Reduce development time and costs: Our predictive, data-driven approach helps you get to the best formulation faster, saving valuable time and resources. [17]
Improve product quality and stability: We design formulations that protect the drug product's integrity, ensuring it's safe and effective. [2]
De-risk development programs: By finding potential formulation issues early, we help avoid costly late-stage failures. [23]
Gain a strategic partner: We work closely with our partners, giving them the expertise and support they need to handle the complexities of drug development.
FAQ
What is the role of formulation in drug development?
Formulation is how you develop a stable, safe, and effective dosage form for a drug. [1, 3] It's a critical part of drug development that can really impact a product's success. [2]
Why is stability so important for biologics?
Biologics are big and complex molecules that can easily break down. [22] A stable formulation is needed to make sure the drug stays high quality and effective over time. [2]
How can AI and predictive modeling help with formulation?
AI and predictive modeling can analyze big datasets to predict which formulations will likely be stable and effective. [16, 18] This can speed up development and cut down on the need for lots of experimental work. [17]
What are the specific challenges of formulating new modalities like viral vectors and mRNA?
These new types of therapies often have unique stability and delivery needs. [13] For example, mRNA is very fragile and needs protection in a lipid nanoparticle to get into cells effectively. [13]
How does Leukocare's approach differ from traditional formulation development?
Leukocare uses advanced analytics, AI-powered predictive modeling, and high-throughput screening to speed up formulation development. This data-driven approach lets us create strong formulations with less time and material.
