developing-ready-to-use-bispecific-antibody-injections
Bringing complex biologics like ready-to-use bispecific antibody injections to market is increasingly challenging. Tight timelines and regulatory demands pressure drug product development teams. Discover collaborative approaches to navigate these hurdles successfully.
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Dealing with Changes in Drug Product Development
FAQ
1. What's Happening Now
2. What's Happening in the Market
3. Problems Now and How We Fix Them
4. How Leukocare Can Help with These Problems
5. How We Help Our Customers
Dealing with Changes in Drug Product Development
Getting new biologics to market is getting trickier. Timelines are tight, regulators expect a lot, and science is exploring new areas with new types of treatments. For leaders in Chemistry, Manufacturing, and Controls (CMC) and Drug Product Development, the pressure to deliver a stable, effective, and product that can be sold has never been greater. This article looks at how drug development is now, its challenges, and how a collaborative approach to formulation can help make things successful.
1. What's Happening Now
The biopharmaceutical industry is in a period of moving fast. We're seeing a clear shift towards more complex molecules, such as viral vectors, RNA-based therapies, and antibody-drug conjugates (ADCs). These advanced therapy medicinal products (ATMPs) offer great potential but also make manufacturing and stability harder. In fact, a 2024 report showed that over 33% of clinical holds by the FDA were due to CMC deficiencies, a number that is on the rise in 2025 [1, 2, 3].
This environment really pressures biotech companies. Virtual and small biotechs, often built around a single promising molecule, need to move quickly to get money and hit clinical goals. They operate with lean teams and rely heavily on external partners. Medium and big drug companies have more people, but they also have their own problems. They often have to fit new treatments into old ways of doing things and deal with complicated internal decisions [4].
Across the board, there is a clear trend of using specialized partners for key development and manufacturing activities to specialized partners like Contract Development and Manufacturing Organizations (CDMOs) [5, 6]. This allows companies to get specific know-how and facilities without spending a lot of money [7].
2. What's Happening in the Market
Several key trends are shaping the drug development market:
Rise of Advanced Modalities: More and more complex biologics are being developed. mRNA-based products, for example, have developed a lot more since the success of COVID-19 vaccines, with over 300 mRNA therapeutics currently in development [8, 9]. This trend needs new ways to formulate and test to make sure products are good and stable.
Getting to Clinic Fast: For many companies, especially fast-track biotechs, the main goal is to get to a Biologics License Application (BLA) or Investigational New Drug (IND) application as fast as possible [3]. This faster timeline puts huge pressure on CMC teams to develop a strong and easy-to-scale formulation and manufacturing process from the very beginning.
More Regulatory Checks: Regulatory bodies like the FDA and EMA are focusing more on really understanding the product and how it's made [10, 11]. For complex biologics, "the process is the product," meaning any change in manufacturing can impact the final drug [11]. This requires careful documentation and a good control plan early in development.
Development Based on Data: The use of artificial intelligence (AI) and machine learning is getting more common in drug development. These technologies can help predict how stable formulations will be, make manufacturing processes better, and look at big datasets to make development less risky [13, 14, 15]. AI-driven tools can speed up timelines and help make better decisions [16].
Changing Partnerships: The relationship between drug developers and CDMOs is getting smarter [4]. Companies are looking for partners who can work like part of their team, not just doing tasks but also giving smart ideas and solving problems.
3. Problems Now and How We Fix Them
CMC and drug product leaders face a number of significant challenges:
Making Complex Molecules Stable: New types of treatments are often naturally unstable [18]. Issues like aggregation, degradation, and high viscosity can make a product less safe or effective [19, 24]. This is often fixed by making very specific formulations with certain ingredients and by using advanced testing to watch stability throughout the development process.
Dealing with Tight Timelines: The rush can make people skip important development steps. The solution is to get CMC planning in really early in the process and to use prediction tools to make development less risky and see problems coming [21]. Early and frequent communication with regulatory agencies can also help make sure everyone's on the same page and avoid delays [23].
Handling Outsourcing Well: Working with multiple external partners can make communication and coordination hard. Successful companies set up clear ways to talk and see their CDMOs as real partners [4]. They look for partners who are proactive and can work on their own but still stay aligned with the project's big picture.
Making More Product: A process that works in the lab may not work for making lots of product. This challenge is fixed by careful process development and testing, making sure the process is strong and can be scaled up [2]. Planning for making lots of product from the start is super important.
Getting People On Board with New Tech: In larger organizations, introducing a new partner or technology can be faced with resistance. This is often solved by doing a small test project first to show it works and build trust before using it everywhere.
4. How Leukocare Can Help with These Problems
Leukocare is set up to directly help with these problems by offering special knowledge in formulation development for complex biologics. Our approach is based on deep science, advanced tech, and working together.
If you're a Fast-Track Biotech Leader needing to move quickly and efficiently, we have a smart formulation platform with AI to predict stability. This helps you quickly develop a strong, regulatory-friendly formulation, speeding up your path to BLA.
For the Small Biotech with CMC Understanding but no internal drug product team, we're a proactive, hands-on partner. We give you the organized processes and documents you need to build a strong CMC case for investors and regulators, taking the burden off your small team.
If you're a Mid-size Biotech trying a new or tough project, we can help you test a new partnership on something specific, like a new treatment type or a lyostability problem. We focus on getting results on a small test project first, showing our value and how we can support your team without messing things up.
For big Pharma Dealing with a New Modality, we offer the deep technical know-how and data insights to make development less risky. With custom workshops and discussions, we act like a sounding board to help your teams feel more confident and make good choices.
If you're a CDMO and a Network Partner, we work as a quiet, smooth extension of your team. We give your clients the formulation expertise they need, making sure projects run smoothly while staying loyal to your CDMO relationship.
5. How We Help Our Customers
What we offer our customers really comes down to a few main things:
Making Development Less Risky: By using advanced science and prediction models, we help find and fix formulation problems early, cutting down the risk of expensive failures later on [21].
Speeding Up Timelines: Our tech and know-how are designed to create stable and easy-to-manufacture formulations fast, helping our partners hit tight deadlines.
Being a Smart Partner: We don't just do the work; we work with you. We work with our partners to figure out the best plan for their specific molecule and goals, like a co-pilot on their development journey.
Making Sure Regulators Approve: Our formulations are made with regulatory rules in mind from day one, giving you the strong data and documents needed for successful submissions [11].
Getting new treatments to patients is tough, but with the right partners and a smart approach to formulation, you can get through it.
FAQ
What's the biggest problem in making biologic drugs today?
One of the most significant hurdles is making sure increasingly complex molecules are stable and can be made, especially with tight development schedules [19, 24]. Advanced therapies like cell and gene therapies have unique problems that need special formulation approaches to stop issues like clumping and breaking down [25, 26].
When should we start thinking about formulation?
You should start thinking about formulation very early, in preclinical development [12, 27]. Focusing early on a stable, scalable formulation can prevent expensive delays and having to redo work later. It's a big part of making the whole development program less risky [21].
How is AI changing how we develop formulations?
AI and machine learning are changing formulation development by making predictive modeling possible [14]. These tools can look at huge amounts of data to predict how stable a formulation will be over time, find the best ingredients, and make manufacturing settings better. This speeds up development and improves the final product [28, 29].
What should you look for in a partner who develops formulations?
Look for a partner with deep scientific knowledge in your specific area, a good history with regulators, and a collaborative way of working [7]. They should act like part of your team, offering proactive solutions and smart advice, not just following a plan [30].
How can we handle the risks of outsourcing to lots of different companies?
Clear and regular communication is super important. Set up a strong project management system and make sure all partners clearly understand the project goals and timelines. It's also important to pick partners who know how to work with many different companies and are committed to being open and working together [31, 32].
