how-to-improve-stability-of-bispecific-antibodies
Developing stable bispecific antibodies is crucial for successful biologic drug products, yet poses significant formulation challenges. Learn how CMC and Drug Product leaders can navigate these complexities, optimize stability, and accelerate timelines. Discover expert strategies within our comprehensive guide.
Menu
Navigating Biologic Formulation in 2025: A Guide for CMC and Drug Product Leaders
Current Situation
Typical Market Trends
Current Challenges and How They Are Solved
How Leukocare Can Support These Challenges
Value Provided to Customers
FAQ
Navigating Biologic Formulation in 2025: A Guide for CMC and Drug Product Leaders
Bringing a new biologic to market is complex. For Chemistry, Manufacturing, and Controls (CMC) and Drug Product (DP) leaders, the pressure is constant: accelerate timelines, manage resources, and make good scientific and regulatory decisions. This situation is shaped by different company structures, from virtual biotechs with lean teams to large pharmaceutical companies venturing into new therapeutic areas.
This article looks at common challenges and solutions in biologic formulation, based on feedback and projects from 2023 and 2024. It guides development leaders on aligning formulation strategy with their company’s specific goals.
Current Situation
The global biologics market is growing a lot, expected to go from $487.00 billion in 2025 to over $1.14 trillion by 2034. This growth is thanks to scientific advances and more demand for targeted treatments for chronic and complex diseases. The industry is also seeing a move toward personalized medicine, with regulators approving more innovative treatments like cell and gene therapies.[1, 3, 11]
This growth makes for a busy but demanding environment. Development teams, no matter their company's size, feel a lot of pressure to move efficiently from preclinical stages to submitting a Biologics License Application (BLA). Every decision, especially in formulation, is important, affecting stability, efficacy, and the product's ultimate success.[2, 4, 5, 25]
Typical Market Trends
Several key trends define how biologic drugs are developed right now.[6, 7]
Strategic Outsourcing: Companies of all sizes are increasingly using external partners for specialized skills. The global biotechnology outsourcing market is expected to grow, driven by manufacturing complexity and the need for specialized infrastructure. This allows even small, virtual companies to get top-tier expertise without heavy initial investment.[8, 9, 10]
Rise of New Modalities: The pipeline has more complex molecules like viral vectors, RNA-based therapies, and antibody-drug conjugates (ADCs). These new formats have unique stability and handling challenges that often don't fit into established, platform-based development approaches.[3, 11]
Focus on Speed to Clinic and BLA: For many biotechs, especially those with fast-track designation, speed is crucial. This puts pressure on CMC teams to run formulation, cell line, and process development at the same time. This tight timeline needs careful planning to avoid expensive mistakes.[5, 25]
Integration of Predictive Technologies: Artificial intelligence (AI) and machine learning (ML) are being used more in formulation development. These tools can predict optimal conditions and screen excipients computationally, possibly reducing the time and materials needed for lab-based experiments.[13, 14]
Current Challenges and How They Are Solved
Across the industry, from virtual startups to established pharmaceutical giants, CMC and DP leaders face common formulation challenges.[15, 16, 17, 26, 27]
1. The Pressure to Move Quickly Without Sacrificing Quality
For a well-funded, virtual biotech with a promising molecule, the main goal is a fast, clear path to BLA. Board-level expectations are high, and there is no room for error. The main issue is the constant time pressure and a distrust of vendors who lack strategic depth.
How it's solved: The answer is finding a proactive, solution-oriented partner who acts as a co-pilot, not just someone who executes tasks. This means working with seasoned CMC professionals who can give a clear, data-driven formulation strategy tailored to aggressive timelines. Using predictive modeling can help find a stable, regulatory-sound formulation faster, reducing risks on the path to BLA.
2. Limited Resources and In-House Expertise
Early-stage biotechs, even with good funding and experienced CMC leadership, often have no internal lab and limited availability. They focus on a secure and efficient path to the Investigational New Drug (IND) application and Phase I trials. They often have bad experiences with academic-style service providers and feel pressure to build a strong CMC story for investors.[15, 18, 24, 27]
How it's solved: These companies need an external partner that works like an extension of their own team, thinking proactively and reducing their internal workload. Success depends on clear communication, structured processes, and documentation that aligns with investor and regulatory needs. The ideal partner brings real understanding, not just jargon, and delivers reliable results without needing a lot of oversight.[19]
3. The Rigidity of Existing Systems
Mid-size biotechs with internal DP teams and established service partners often face a different issue. Their internal processes can be slow, and bringing on new vendors through procurement is hard. They hit limits when they're busy, a project needs specialized expertise for a new modality, or their current vendors are overloaded.
How it's solved: The way to approach this is to hire a specialist for a specific, clear challenge, like lyostability or a new modality. A pilot project is a good way to test a new partner and show their value without causing problems. This lets the company scale flexibly and bring in top specialists for tricky cases without messing up established workflows.
4. Navigating New Therapeutic Territory
Large pharmaceutical companies have many resources, but they can feel unsure when dealing with new modalities like viral vectors or RNA. Key experience gaps can slow down decisions. Their issues include complex internal approval processes and dealing with vendors who offer generic, templated solutions.
How it's solved: These teams need a real thought partner for modality-specific questions. They benefit from access to deep technical knowledge through specific insights, case studies, and tailored materials that help get internal buy-in. Short workshops and educational sessions can build internal knowledge and confidence in making regulatory-sound decisions.
How Leukocare Can Support These Challenges
A forward-thinking formulation partner can help address these varied challenges through a collaborative and science-first approach.
For teams needing speed and quality, Leukocare's Smart Formulation Platform, which uses AI-based stability prediction, provides a data-driven path to a commercially ready formulation. This allows for parallel optimization of CMC components, helping clients reach the BLA faster with a formulation designed for regulatory success.
For small biotechs with resource gaps, we act as a strategic co-pilot. We provide a clear point of contact, proactive ideas, and quick turnaround. Our structured processes and documentation are designed with investors and regulatory bodies in mind, building a robust CMC story based on genuine understanding.
For mid-size biotechs needing flexibility, we offer a way to get started with a specific, complex problem. We can show how we support internal DP teams, not compete with them. Our "pilot first, scale second" model lets the results speak for themselves, demonstrating our ability to deliver on tough challenges before growing the partnership.
For large pharma and CDMOs requiring seamless integration, we provide deep tech know-how and act as a quiet, neutral formulation partner. Our approach is adaptable and practical, ensuring smooth project execution. We stay loyal to the client relationship, delivering science-backed results without trying to steal clients.
Value Provided to Customers
The goal of any formulation partnership is to deliver clear, tangible value that aligns with the client's business objectives.
De-risking the Path to Market: For fast-track biotechs and companies tackling new modalities, the main value is a tailored, data-driven formulation that stands up to regulatory scrutiny. This gives confidence and a clearer, faster route to BLA submission.
Structure, Speed, and Substance: For small, lean teams, the value comes from hands-on support and data-informed decision-making that speeds up development for Phase I. It’s about getting reliability and a strong data package for the next stage.[20, 21]
On-Demand Expertise: For mid-size companies, the value is in having a trusted partner to solve complex or overflow challenges without long-term commitments. This provides delivery and data-driven expertise exactly when needed.
Seamless and Silent Partnership: For CDMOs, the value is a low-maintenance, quiet partner who delivers data-driven formulation decisions with minimal fuss. This strengthens their service offering and helps keep clients.
By understanding the specific pains and goals of different players in the biotech ecosystem, a formulation partner can move beyond a simple service-provider role and become a true strategic asset.[22]
FAQ
1. My company is virtual with no internal lab. At what stage should we engage a formulation partner?
It is best to engage a formulation partner during the preclinical stage, as early as when you are selecting a lead candidate. Early formulation work can inform candidate selection and reduce development risks by ensuring the molecule has a viable path forward. An early start allows for developing a strategy that aligns with your timeline for IND and BLA submissions.[18, 23, 24]
2. We already have a primary CDMO. How can a specialized formulation partner work with our existing setup?
A specialized formulation partner can integrate with your existing setup by focusing on specific, complex challenges that fall outside your primary CDMO's core strengths or when they are at capacity. This is often done through a pilot project on a niche issue like lyostability or a new modality. The goal is to support and fill gaps for your internal and external teams, not to replace or override them.[5, 25]
3. How can predictive modeling and AI actually shorten our development timeline?
Predictive modeling and AI accelerate timelines by running thousands of in silico simulations to identify the most promising formulation conditions before starting extensive lab work. This reduces the number of physical samples needed, saves expensive material, and shortens the time required for experimental screening. By focusing lab work on the highest-probability candidates, a stable, optimized formulation can be identified much faster.[15, 16, 17, 26, 27]
4. What kind of data is needed to start a formulation development project for a new modality?
To begin, the partner would need information on the molecule itself, including its structure, sequence, and any known instabilities. Data from early developability assessments, the target product profile, the intended route of administration, and the desired final concentration are also important. For new modalities, sharing any existing data on similar molecules or specific challenges encountered can help tailor the formulation strategy from day one.[28]
