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Navigating the complexities of drug development, especially with high-viscosity bsAb drug products, requires expert formulation. Discover how a strategic CDMO partnership can ensure stability and accelerate your market journey.
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The Evolving Rhythm of Drug Development: Finding the Right Partner for a Faster, Cleaner Path to Market
FAQ
Current Situation
How Leukocare Can Support These Challenges
Value Provided to Customers
The Evolving Rhythm of Drug Development: Finding the Right Partner for a Faster, Cleaner Path to Market
The journey of a new drug from concept to clinic is more demanding than ever. Molecules are becoming more complex, timelines are shrinking, and the pressure to succeed is immense. For leaders in Chemistry, Manufacturing, and Controls (CMC) and drug product development, this environment calls for a strategic approach, particularly when it comes to formulation. Getting the formulation right is fundamental to creating a stable, safe, and effective medication. It’s a process that can define a drug's success, influencing everything from stability and bioavailability to manufacturability and patient acceptance. [1, 2]
Current Situation
Today’s drug development landscape is all about speed and specialization. Virtual and small biotech companies are responsible for a growing portion of new medicines, operating with lean teams and relying heavily on external partners to advance their pipelines. These companies, often backed by significant funding and focused on a promising, high-value molecule, need to move quickly toward Investigational New Drug (IND) or Biologic License Application (BLA) filings. The pressure from boards and investors is intense, so there's no room for error or delays. [3, 4, 5, 6, 22, 7]
At the same time, large pharmaceutical companies are tackling new and challenging modalities like viral vectors, RNA-based therapies, and cell and gene therapies. While they have internal resources, these new technologies often create knowledge gaps and internal uncertainties, particularly in developing a robust drug product strategy. The complexity of these biologics, from their intricate structures to their potential for immunogenicity, creates unique challenges. [8, 9, 20]
This reality has led to a surge in outsourcing. The global market for formulation development outsourcing was estimated at over USD 37 billion in 2024 and is projected to grow significantly. Companies are increasingly relying on Contract Development and Manufacturing Organizations (CDMOs) not just for capacity, but for specialized expertise and strategic partnership. [10, 11]
Typical Market Trends
Several key trends are shaping how drug development leaders approach their work:
The Rise of Strategic Partnerships: The relationship between drug developers and CDMOs is evolving from a transactional, fee-for-service model to a more collaborative, strategic partnership. Companies are seeking partners who can provide end-to-end support, from early development through commercial manufacturing, minimizing the risks associated with tech transfer and improving efficiency. Some models even involve shared investments and risk-sharing to align the goals of both parties. [13, 14, 15]
A Boom in Biologics and New Modalities: Biologics continue to dominate the development pipeline, with a higher probability of reaching approval compared to small molecules. This, along with the rise of cell and gene therapies, is driving demand for specialized manufacturing and formulation expertise. These complex therapies require advanced technologies and a deep understanding of unique CMC challenges, from handling viral vectors to ensuring the stability of genetic material. [16, 18, 12, 19]
Pressure to Accelerate Timelines: The push to get therapies to patients faster is relentless. Regulatory pathways like the FDA's Fast Track and Accelerated Approval are encouraging rapid development, but this can create significant manufacturing and quality challenges down the road if foundational work is rushed. The industry saw how timelines could be compressed during the COVID-19 pandemic and is now applying those lessons to other disease areas. [20, 9, 21, 23, 22, 7]
Integration of AI and Machine Learning: Artificial intelligence is rapidly moving from a buzzword to a practical tool in formulation development. AI-driven platforms can analyze vast datasets to predict successful formulation combinations, solve solubility challenges, and optimize drug delivery systems. This technology helps reduce development time and costs by making the process more predictive and less reliant on trial-and-error. The use of AI is becoming a key trend for optimizing drug formulations. [21, 23, 24, 25, 26, 27, 28]
Current Challenges and How They Are Solved
CMC and Drug Product leaders deal with common challenges that need good solutions:
Challenge: The "How to Break In" Dilemma. Mid-size biotech and large pharma companies often have established relationships with service providers, but they can hit limitations when dealing with new or difficult projects, or when their primary partners are overloaded. Onboarding a new vendor through procurement is often a slow and difficult process.
Solution: The solution is often to test a new partner on a specific, well-defined problem. This could be a pilot project focused on a unique challenge, like a new modality or a lyostability issue. This "proof through pilot" approach allows the new partner to demonstrate their value and build trust without disrupting existing workflows. It’s about delivering results first, then scaling the relationship.
Challenge: Skepticism Toward Superficial Vendors. For fast-track virtual biotechs, there is no time for partners who lack strategic depth. They are under extreme pressure and cannot afford missteps. They need a partner who is more than just an executor; they need a strategic co-pilot who can think critically and proactively.
Solution: Data-driven science and peer-level collaboration are the answer. Partners who can offer predictive modeling, customized design of experiments (DoEs), and a forward-thinking approach win their trust. They need to see a clear, clean path to BLA, guided by a team that understands the regulatory journey and can anticipate challenges.
Challenge: Limited Bandwidth and Fear of Friction. Small biotechs with lean teams and no internal lab capacity are entirely dependent on their external partners. They have often had poor experiences with academic-style service providers and are wary of partners who create more work than they take on. They need a simple, low-friction outsourcing setup.
Solution: These companies need a partner who acts as an extension of their team. This means clear communication, proactive suggestions, and quick turnarounds. A structured process with documentation for investors and regulatory bodies is crucial. The focus should be on providing real understanding and tangible results, not just jargon.
Challenge: The CDMO as a Network Partner. Many CDMOs offer drug substance and fill-finish services but lack in-house formulation expertise. When their clients ask for formulation services, they need a reliable, neutral partner to bring into the network without risking their client relationships.
Solution: The ideal formulation partner for a CDMO is one that can operate discreetly and effectively in the background. They need to execute independently, communicate smoothly, and remain loyal to the CDMO partnership without any attempt to poach clients. This requires an adaptive, pragmatic, and hands-on approach.
How Leukocare Can Support These Challenges
Leukocare helps with these specific industry challenges using advanced technology, a collaborative mindset, and tailored service models.
For the Fast-Track Biotech Leader, we provide a faster, cleaner path to BLA. Our Smart Formulation Platform, combined with AI-based stability prediction, offers a data-driven approach that is designed for aggressive timelines and regulatory success. We engage as strategic co-pilots, working at a peer level with seasoned CMC professionals to ensure the formulation is robust and commercially ready.
For the Small Biotech with limited internal resources, we offer structure and speed. We act as a proactive partner, providing a clear point of contact and structured processes that align with both investor and regulatory expectations. Our goal is to reduce the internal workload for our clients by delivering reliable, data-informed results without the overhead of academic-style projects.
For the Mid-size Biotech looking to "break in" a new partner, we provide a low-risk entry point. We can tackle specific, complex problems, like those involving a new modality or lyostability, through a pilot project. This allows us to demonstrate our value and show how we can support internal drug product teams without replacing or overriding them. We deliver first, then scale.
For the Pharma Company Tackling a New Modality, we offer deep technological and modality-specific understanding for vectors, ADCs, and more. We don’t offer generic templates; we guide the development path with real data and tailored formulation design. Through mini-workshops and deep dives, we provide the specific insights and arguments needed to support internal decision-making and de-risk the new venture.
For the CDMO seeking a Network Partner, we act as a silent, seamless extension of their team. We offer a pragmatic, hands-on approach, ensuring independent execution with minimal friction. Our loyalty is to the CDMO relationship, providing a science-backed formulation service that is discreet and adaptive, strengthening their full-service offering.
Value Provided to Customers
Our approach is designed to provide clear, tangible value to our customers by addressing their core pains and delivering on their key goals.
For leaders under pressure to move fast: We help you reach BLA faster with a formulation designed by science, guided by data, and built for regulatory success.
For teams with constrained bandwidth: We provide structure, speed, and substance—driven by data and delivered with reliability—to support fast development for Phase I.
For those facing complex challenges: We solve specific problems using our modeling platform and formulation intelligence to deliver results you can trust.
For innovators exploring new modalities: We guide your path with real data, expertise, and a tailored formulation design, avoiding generic templates.
For our CDMO partners: We act as your formulation team—silent, seamless, and science-backed—while remaining loyal to your client relationship.
In a field defined by complexity and urgency, the right partnership makes all the difference. It's about finding a collaborator who understands your specific challenges and has the tools, mindset, and flexibility to help you succeed.
FAQ
Q1: How does outsourcing formulation development help accelerate the path to IND/BLA?
Outsourcing to a specialized partner can accelerate timelines by providing immediate access to advanced technologies, experienced personnel, and established processes. This avoids the time and capital expenditure required to build these capabilities in-house. A dedicated formulation partner can run activities in parallel with other development work, such as cell line and process development, compressing the overall project timeline. [15]
Q2: My company is virtual and has no internal lab. How can we maintain oversight and ensure our project is on track?
Virtual companies thrive on strong communication and collaboration with their partners. The key is to work with a partner that offers structured processes, a clear point of contact, and proactive communication. Regular meetings, detailed documentation aligned with investor and regulatory needs, and a collaborative mindset ensure that you remain in control and fully informed, even without a physical lab. [30, 31, 32]
Q3: We have existing partnerships with other service providers. How can we integrate a new formulation specialist without causing friction?
The best approach is to start with a specific, well-defined project, such as a pilot study for a particularly challenging molecule. This allows you to evaluate the new partner's capabilities and working style in a controlled manner. A good partner will focus on supporting your internal teams, not competing with or overriding them, ensuring a smooth integration and demonstrating their value through tangible results. [16]
Q4: What is the real-world impact of using AI and predictive modeling in formulation?
AI and machine learning can significantly de-risk and speed up formulation development. These tools can rapidly screen vast numbers of potential formulations to identify the most promising candidates, predict stability issues early, and optimize drug delivery profiles. This data-driven approach reduces the need for extensive, time-consuming experimental work, leading to faster, more informed decision-making. [24, 25, 26, 27]
Q5: We are a CDMO that doesn't offer formulation. How can we offer a full-service package without building an entire internal team?
Partnering with a neutral, external formulation specialist allows you to offer a complete service package without the investment and overhead of an internal team. The right partner will work as a seamless extension of your services, handling the formulation work independently while maintaining clear communication. This model requires a high degree of trust and a partner who is loyal to the CDMO relationship. [28, 13, 14]
