reconstitution-stability-of-lyophilized-bispecific-antibodies
Developing complex biologics like bispecific antibodies presents unique formulation challenges, especially concerning their reconstitution stability. Missteps can lead to significant delays and financial losses in the journey to market. Discover how to overcome these hurdles and accelerate your drug development.
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Navigating Formulation Challenges in Modern Biologic Development
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
Navigating Formulation Challenges in Modern Biologic Development
The path to bringing a new biologic to market is becoming more complex. Molecules are more complicated, timelines are tighter, and regulatory expectations are higher than ever. For leaders in Chemistry, Manufacturing, and Controls (CMC) and Drug Product (DP) development, this environment creates big challenges, as well as opportunities. Success depends not just on the science of a molecule but on the smart choices made from the very beginning.
1. Current Situation
The biopharmaceutical industry is seeing a lot of fast innovation. Between 2015 and 2019, biologics made up a quarter of all new chemical entity approvals, a trend that's still speeding up. [1] The global biologics market is expected to grow a lot, driven by an aging population and a rising need for advanced therapies for chronic diseases. [3] This growth is driven by small, new biotech companies. They're often the ones pushing innovation but don't always have a lot of resources. [4, 5, 21]
These companies, whether they're virtual startups or established pharma players trying new things, are under a lot of pressure to move quickly. [4] The journey from discovery to a Biologics License Application (BLA) is long and costly, and any misstep in development can lead to big delays and lost money. [6] As a result, the "process is the product" idea has never been more important; how you make and formulate the drug is tied to the drug itself. [7]
2. Typical Market Trends
Several key trends are changing how drugs are made.
The Rise of Outsourcing: More companies are relying on external partners for specialized help. The global biotechnology outsourcing market is expected to grow at a rate of 9.4% from 2024 to 2030. [8] This isn't just for routine tasks; it includes complicated development work that needs a lot of knowledge. [4] Small, new biotechs, especially, depend on contract development and manufacturing organizations (CDMOs) to get their drug candidates ready for clinical trials. [4]
New Therapeutic Modalities: The industry is moving beyond traditional monoclonal antibodies into more complex areas like viral vectors, RNA-based therapies, and antibody-drug conjugates (ADCs). [4] These new modalities come with unique stability and delivery challenges that need new ways of formulating them. [12, 13]
Accelerated Timelines: Regulatory pathways like Fast-Track designation make teams deliver quickly for patients. [4] This means that process and formulation development must happen at the same time, making CMC activities even more complicated.
The Role of Technology: Artificial intelligence and machine learning are starting to play a role in formulation development. These technologies can help predict stability, make formulations better, and look at complicated data faster than traditional methods. [14, 15, 16]
3. Current Challenges and How They Are Solved
With these trends come challenges CMC and DP leaders deal with every day.
Ensuring Stability and Quality: Biologics are really complex and sensitive molecules. [17] They can break down at any stage, from manufacturing to storage, and can be affected by things like temperature and pH. [3] A big problem is preventing aggregation, where proteins clump together, which can lead to a loss of activity. [3] The usual solution involves long, time-consuming stability studies. The industry often needs three years of real-time data collection to understand long-term stability. [18, 19]
Navigating New Modalities: A company with a lot of experience in monoclonal antibodies might find its internal knowledge doesn't apply to a new viral vector or RNA program. These therapies need special manufacturing and formulation methods. [20] For example, some viral vectors are too sensitive for standard sterile filtration methods. [20] Companies often solve this by carefully bringing in outside specialists, but finding the right partner with real expertise can be hard.
Pressure to Move Quickly with Limited Resources: Virtual and small biotech companies feel this the most. They have promising molecules and good funding but no in-house labs or large teams. [6] They need to get to the Investigational New Drug (IND) or Phase I stage quickly and safely. [6] This often leads to tough decisions about how to spend limited money while following regulations. [6] Bad experiences with service providers who act more like academic labs than true partners can make people skeptical and slow things down.
Onboarding and Managing Partners: Even for mid-size and large pharma companies, bringing on a new vendor can be a slow and tough process. Strict internal purchasing rules can make it difficult to hire a specialist for a single, urgent project. For CDMOs looking to offer formulation as part of a full-service package, there's a risk that an external partner might be unprofessional, need too much oversight, or even try to take over the client relationship.
4. How Leukocare Can Support These Challenges
Dealing with these modern drug development challenges needs a partner that thinks differently. At Leukocare, we work with companies to provide targeted formulation support that's based on data and made to help with regulatory approvals.
For the fast-track biotech leader, we offer a smart formulation platform that uses AI-based stability prediction. This means we use a data-driven approach that's fast, reliable, and forward-thinking. We work with CMC professionals as partners who help guide things, not just do the work, to find the easiest way to BLA.
For the small biotech with CMC understanding, we provide clear, upfront communication and structured processes. We get the pressure to build a strong CMC story for investors and regulators. Our goal is to offer real understanding and be part of your team, delivering results that provide structure, speed, and reliability.
When a mid-size biotech faces a specific, difficult challenge, like a new modality or a stability issue with an existing product, we can step in to solve that one problem. We prove our value through a pilot project first, showing how our modeling platform and formulation intelligence can provide reliable results. We support internal DP teams, we don't look to replace them.
For a large pharma company tackling a new modality, we serve as a true sparring partner. We provide a lot of technical knowledge in areas like vectors and ADCs through custom materials and workshops. We don't use generic templates; we help you with your modality journey with real data and expertise.
And for the CDMO seeking a network partner, we act as a silent, smooth extension of your team. We offer a practical, flexible approach focused on doing the work independently. Our loyalty is to the CDMO relationship, making sure we deliver for your client without causing problems or risk.
5. Value Provided to Customers
Our approach is meant to give real value to our customers.
De-risking Development: By using predictive modeling and data-based methods, we help find and fix possible formulation problems early. This reduces the risk of expensive failures later in development. For companies trying new types of drugs, our special knowledge helps make the entire development path less risky. [18, 19]
Accelerating Timelines: Our methods can predict long-term stability using short-term data, helping to speed up development. For companies on a fast track, this means hitting goals and getting to the BLA faster. [18, 19]
Building a Strong Regulatory Case: We provide the documentation and data-supported reasons needed for a strong regulatory application. Our structured processes make sure the formulation story is clear, convincing, and matches what investors and regulators expect.
Enabling Partnerships: For our CDMO partners, we help them offer a full-service solution without the cost and extra work of an internal formulation team. This helps them make client relationships stronger and run projects smoothly. [21, 5]
The goal is to go beyond the usual, often reactive, way of doing formulation. By acting as a partner that works with you and uses data, we help bring safe and effective therapies to patients more effectively.
FAQ
What is the best way for a virtual company to manage formulation development?
For a virtual company, success depends on choosing the right partners. Look for a formulation partner that can act as a partner who guides things, not just does the work. They should have a data-driven approach, like using predictive models for stability, to increase the chances of success and move quickly. Early and clear communication is key to make sure it fits with your CMC strategy.
How can we de-risk the transition from a well-known molecule class to a new modality like RNA?
When moving into new modalities like RNA or viral vectors, it is important to admit what you don't know internally. Partner with a specialist who has a lot of technical experience in that specific area. [13] Start with a small pilot project focused on a key challenge, such as lyostability or delivery. This allows you to test the partnership and gain confidence before committing to a larger program. A real sparring partner can give specific advice and help you with internal decisions.
Our internal DP team is overloaded. How can an external partner help without messing up what you already do?
The right external partner should support your team, not compete with it. Look for a partner who can take on extra work or handle a specific small challenge that's stretching your team thin. The goal should be to find a flexible solution that can scale up or down as needed. A successful partnership will deliver results without causing drama or problems for your internal workflows.
How can we be sure that an outsourced formulation partner will remain loyal to our CDMO?
This is a fair question. When a CDMO brings in a formulation specialist, that partner's role is to be discreet, flexible, and loyal to the CDMO relationship. Before engaging a partner, have open discussions about their working model. They should be able to do their work independently, without creating extra work to coordinate for you or becoming too visible to your client. Their focus should be on delivering smooth, science-backed results that make your CDMO look good.
