developing-low-viscosity-high-concentration-bsab-formulations
Formulation can make or break a new biologic's journey to market, often causing significant delays for CMC and Drug Product leaders. Discover how a data-driven approach to developing low-viscosity high-concentration bsAb formulations can ensure product stability and patient success. Continue reading to navigate these complex challenges.
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Decoding Drug Product Development: A Guide for CMC and Drug Product Leaders
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
Decoding Drug Product Development: A Guide for CMC and Drug Product Leaders
Formulation is a critical, yet often underestimated, part of bringing a new biologic to market. For leaders in CMC and Drug Product Development, navigating the path from a promising molecule to a stable, effective, and patient-friendly treatment is a familiar challenge. This article will look at the current state of drug product development, its challenges, and how a thoughtful, data-driven approach to formulation can help succeed.
1. Current Situation
The biopharmaceutical market is growing, with projections showing an increase from approximately $400 billion in 2023 to around $600 billion by 2030. This growth is fueled by advancements in treating chronic diseases and a greater acceptance of innovative therapies. The journey from discovery to an approved product is long, often taking about 10 years to move from initial clinical trials to regulatory approval.[1]
Formulation development is a key factor in this journey. In fact, a 2018 survey of biopharmaceutical professionals identified formulation as one of the most important considerations in drug product development. Poor formulation can lead to significant delays, with one survey indicating that over half of respondents experienced delays of more than a year due to formulation issues. These delays can have a major impact on a drug development program.[2]
The complexity of today’s biologics, including new molecule classes like viral vectors and RNA, adds another layer of difficulty. These advanced therapy medicinal products (ATMPs) present unique challenges in ensuring product quality, consistency, and stability.[3, 4]
2. Typical Market Trends
The industry is seeing several key trends that shape how companies approach formulation and drug product development.
Outsourcing is on the rise. The global market for formulation development outsourcing was valued at $26.2 billion in 2024 and is expected to grow to over $50 billion by 2033. Many pharmaceutical and biotech companies are choosing to outsource at least part of their formulation development to access specialized knowledge and speed up timelines. This is particularly true for small and mid-sized firms looking to reduce costs and focus on their core research.[6, 7]
New partnership models are emerging. The relationship between drug developers and contract development and manufacturing organizations (CDMOs) is shifting from a simple fee-for-service model to more strategic partnerships. These can include risk-sharing agreements and integrated services that cover the entire development process, from drug substance to drug product.[9]
AI and machine learning are gaining traction. Artificial intelligence (AI) and machine learning (ML) are being used to accelerate drug formulation. These technologies can predict a drug's stability, solubility, and other properties, which helps to streamline the development process and reduce the need for extensive trial-and-error experiments.[13, 21] Some believe that using AI can increase the chance of finding the right formulation components threefold.[14, 15]
A focus on reducing risk in development. With a high rate of failure for drugs in development, there is a strong emphasis on reducing risk in the process as early as possible. This involves using assessment tools and conducting formulation studies early to identify potential issues and improve the chances of success.[17, 18, 19]
3. Current Challenges and How They Are Solved
CMC and Drug Product leaders face a number of challenges in today's environment. Here are some of the most common, along with how they are being addressed:
The Complexity of New Modalities: Advanced therapies like viral vectors, RNA-based medicines, and other complex biologics come with unique formulation challenges. These molecules are often inherently unstable, making them difficult to work with.[4] Solving this requires deep knowledge in areas like lyophilization (freeze-drying) and a good understanding of the specific degradation pathways of these molecules.[20]
Tight Deadlines and the Need for Speed: For companies with fast-track candidates, the pressure to move quickly to Biologics License Application (BLA) is immense. This often means optimizing the cell line, process, and formulation in parallel. The solution is using predictive modeling and data-driven approaches to accelerate formulation development, cutting down the time it takes to find a strong, commercially-ready formulation.[21]
Limited Internal Resources: Many small and mid-size biotech companies operate with lean teams and may not have a dedicated internal drug product department. They often rely on external partners to provide the necessary support.[22] The key is to find a partner who can act as an extension of their team, offering proactive and solution-oriented communication.
Navigating Outsourcing and Partnerships: While outsourcing is common, it comes with its own set of challenges. Finding the right CDMO partner is crucial, and the relationship needs to be managed effectively. New partnership models that emphasize collaboration and shared goals are helping to address this.[9] For larger pharma companies, the challenge can be integrating new, specialized vendors into established internal processes.[12, 23]
4. How Leukocare Can Support These Challenges
Leukocare can help with these challenges through a combination of advanced technology, a lot of scientific knowledge, and a collaborative approach.
Data-Driven Formulation Development: We use a smart formulation platform combined with AI-based stability prediction to accelerate the development of strong formulations. This data-centric method allows for a more rational design of experiments, reducing the time and resources needed compared to traditional screening methods.[21]
Expertise in Complex Modalities: Our team has extensive experience working with a wide range of biologics, including viral vectors and RNA-based therapeutics. This specialized knowledge allows us to tackle the unique stability challenges presented by these complex molecules.[25]
Collaborative Partnership: We work as a strategic co-pilot with our clients, providing not just execution but also proactive, solution-oriented input. For companies without an internal drug product team, we can act as an extension of their CMC leadership. For larger organizations, we can provide specialized expertise to support their internal teams on particularly challenging projects.[21]
Easy Integration and Support: We offer end-to-end drug product development services, from formulation to analytics, which helps to streamline the path to IND and BLA submission. Our approach is designed to be flexible, whether we are serving as a primary formulation partner or being brought in by a CDMO as a neutral, third-party expert.[21]
5. Value Provided to Customers
The goal is to provide value to our customers by helping them bring better products to market, faster.
For the Fast-Track Biotech Leader: We provide a clear and rapid path to a regulatory-sound, commercial-ready formulation, helping to meet tight deadlines and board-level expectations.
For the Small Biotech: We offer the structure, speed, and substance needed for a successful path to IND, acting as a proactive partner that reduces the internal workload.[21]
For the Mid-size Biotech: We provide reliable, data-driven expertise for overflow or niche challenges, allowing internal teams to scale flexibly without adding permanent headcount.[2]
For Pharma Tackling a New Modality: We guide the development path with real data and tailored formulation design, reducing risk in the entry into new therapeutic areas.[2]
For the CDMO Network Partner: We act as a silent, seamless, and science-backed formulation team, helping the CDMO offer a full-service solution while maintaining loyalty to their client relationship.[2]
By understanding the specific pains and goals of each of these customer types, we can tailor our support to provide the most value.[9]
FAQ
What is the difference between SMART Formulation® and classic screening?
SMART Formulation® uses a data-science-guided approach to screen excipients, which allows for the development of strong formulations more quickly than traditional buffer screening methods.
How long does a typical formulation project take?
The timeline for a formulation project can vary depending on the complexity of the molecule. By using data-driven methods, we aim to deliver strong formulations in weeks, not months.[21, 25]
Can you supply non-GMP material for pre-clinical studies?
Yes, we can provide non-GMP materials for use in pre-clinical studies.[21]
What molecule classes do you work with most often?
We work with a wide range of biologics, including vaccines, viral vectors, and other complex proteins.[25]
