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The journey of a biologic drug from lab to patient is complex, with formulation being a critical and challenging phase. Discover how custom formulation design addresses the unique needs of novel bsAb formats amidst shifting market trends to keep you ahead.
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The Shifting Landscape of Biopharmaceutical Formulation
FAQ
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
The Shifting Landscape of Biopharmaceutical Formulation
The journey of a biologic drug from lab to patient is complex. Formulation, which means picking the right stuff to make sure a drug is stable, works well, and gets delivered safely, is a super important and often tough part of this journey. For folks leading CMC and Drug Product Development, staying ahead means understanding scientific innovation, market trends, and practical challenges.
1. Current Situation
The biopharmaceutical market is growing fast, expected to be worth nearly $949 billion by 2032, up from $462.8 billion in 2024. [1] This growth comes from an aging population, more chronic diseases, and a rising need for targeted treatments. [1] Biologics, like monoclonal antibodies, vaccines, and cell and gene therapies, are becoming super important for treating many conditions. [2, 3, 4, 28]
Getting these complex molecules to market is a long and expensive process, taking about 10 years from first human trials to regulatory approval. [28, 3] Biologics are complex, which creates unique problems. [27, 5] These large molecules are often unstable and can break down easily, so careful formulation is necessary to keep them intact.
2. Typical Market Trends
A few key trends are shaping the biopharmaceutical world:
Outsourcing is growing: Many companies are working with contract development and manufacturing organizations (CDMOs) to help with the tough parts of drug development. [8] One survey of biologics companies found that 57% expect to outsource more. [11] This lets companies get specialized help and resources without huge upfront costs. [8]
New partnership models are popping up: The old, simple way drug developers and CDMOs used to work together is changing. [12, 32, 33] Companies are now looking for more collaborative, strategic partnerships. [13] This can involve working together early on to see how things go before committing to longer deals. [13]
Advanced therapies are gaining ground: Developing advanced therapy medicinal products (ATMPs), such as gene and cell therapies, is a growing area. [14, 15] These therapies could potentially treat many conditions, but they also have unique manufacturing and formulation challenges. [14, 15, 16]
Digitalization and AI are changing the industry: Artificial intelligence and machine learning are being used to speed up drug discovery and development. [18, 19, 20] These technologies can help predict which drug candidates might work best, make manufacturing processes better, and even help design formulations. [18, 19, 20, 23, 24]
3. Current Challenges and How They Are Solved
Even with these new trends, big challenges remain.
Formulation challenges: Making a stable and effective formulation for a complex biologic can be a huge obstacle. Degradation is a common issue, and not understanding how it happens can lead to expensive mistakes. To fix this, companies are using various stress tests to better understand how a molecule behaves in different situations.
Early-stage risk: The beginning stages of drug development are very risky, with many failures. [26, 27] To reduce this, companies are using "developability assessments" to find and fix potential problems early on. This might involve a mix of computer modeling and lab tests to guess how a molecule will act. [26, 27]
Outsourcing complexities: Outsourcing has many benefits, but it also brings its own set of problems. [3, 28] Picking the right partner is super important, and you need to carefully check their experience, track record, and technical skills. [28] Clear communication and a well-defined plan are key for a successful partnership. [28]
Advanced therapy challenges: Developing ATMPs is especially complicated. [14, 15] These therapies often use patient-specific materials, which can make the final product vary. [14, 15, 16] The small number of patients for many of these therapies also makes it hard to justify the high cost of large-scale manufacturing. [14, 15]
4. How Leukocare Can Support These Challenges
Leukocare is in a great position to help companies with these challenges. We offer specialized formulation development services, focusing on biologics and advanced therapies. Our approach is based on really understanding the science behind drug stability, along with using top-notch technology.
Our Smart Formulation Platform uses AI-based stability prediction to help our clients choose the best formulation for their molecule. This data-driven approach lets us customize formulations for tight deadlines and reduce risks in the development process. We work closely with our clients, acting as a strategic partner to help them reach their goals.
We get the pressure our clients face, from tight timelines and board expectations to the doubt that can come from bad past experiences with other service providers. We offer a clear, proactive way of working, focusing on giving structured, reliable results.
5. Value Provided to Customers
By partnering with Leukocare, our clients can:
Reach BLA faster: Our data-driven formulation approach is designed to speed up timelines and provide a clear path to regulatory approval.
De-risk development: Our early-stage assessments and predictive modeling help find and fix potential issues before they cause expensive delays. [27, 5]
Gain a strategic partner: We offer more than just technical services. We work closely with our clients to understand what they need and provide proactive, solution-oriented support.
Access specialized expertise: Our team has deep experience in formulation development for a wide range of biologics and advanced therapies.
The biopharmaceutical industry is always changing. By staying on top of trends and teaming up with the right experts, companies can handle the challenges of drug development and bring innovative new therapies to patients.
FAQ
What is the biggest challenge in biologic drug development?
One of the biggest challenges is that biologic molecules are naturally complex and unstable. [27, 5] This makes formulation a really critical and often tough step in the development process. [30, 31]
How is AI being used in drug development?
AI is used in many ways, from speeding up drug discovery to making manufacturing processes better. [18, 19, 20] For formulation, AI can predict which excipients will work best and help design more stable and effective drug products. [23, 24]
What is a CDMO?
A CDMO is a contract development and manufacturing organization. These companies offer various services to the pharmaceutical industry, from early-stage development to commercial manufacturing. [12, 32, 33]
What are ATMPs?
ATMPs are advanced therapy medicinal products. [14, 15] This group includes innovative therapies like gene therapies, somatic cell therapies, and tissue-engineered products. [16]
Why is early-stage development so important?
The early stages of drug development are super important for finding and reducing potential risks. [27, 5] By addressing problems early on, companies can avoid expensive delays and boost their chances of success. [26, 27]
