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The biopharma world is fast-changing, presenting constant challenges for drug product development. Are you ready to optimize formulation for subcutaneous delivery of bispecifics? Discover strategies to navigate these complex hurdles and stay ahead.
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Getting Around Formulation: A Guide for Biotech Leaders
1. What's Happening Now
2. What's Trending
3. Problems and Solutions
4. How Leukocare Can Help with These Problems
5. What We Offer Our Clients
6. FAQ
Getting Around Formulation: A Guide for Biotech Leaders
The biopharma world is changing fast, driven by new technologies and more focus on personalized medicine.[1, 2] For leaders in Chemistry, Manufacturing, and Controls (CMC) and drug product development, this means always new challenges. This article will talk about what's happening now, what's new, and how to handle the tough parts of formulation.
1. What's Happening Now
The biopharma market is getting bigger, worth over $400 billion in 2024 and set to grow significantly.[3] This growth is driven by more demand for biologics, targeted therapies, and treatments for chronic and rare diseases.[3] There's a clear increase in clinical trials for biologics, which now happen more than for small molecule drugs. This trend shows how complex drug development is getting and why we need specialized scientific knowledge.
This growth also brings some challenges. Regulators are swamped because so many complex drugs are being submitted. Even though this means more new drugs are getting approved than ever, it also means CMC data and manufacturing get a lot more attention.[4, 5] For biotech companies, especially smaller ones, poor CMC planning can cause big delays and cost a lot of money.[6, 7, 23]
2. What's Trending
A few big trends are shaping how formulations are developed:
More companies are outsourcing: The global formulation development outsourcing market was valued at over $37 billion in 2024 and is expected to keep growing.[11, 8] Companies are teaming up more with Contract Development and Manufacturing Organizations (CDMOs) to save money, get special skills, and develop drugs faster.[8, 9, 11] This is especially true for smaller and medium-sized companies that might not have the in-house staff or tools for tricky formulations.[11, 8]
New types of treatments mean new challenges: The development of advanced therapies like viral vectors, RNA-based treatments, and antibody-drug conjugates (ADCs) come with their own special formulation problems.[12, 13, 14] These molecules are often more complicated and less stable than traditional biologics, so you need specialized knowledge to make sure they're safe and work well.[15, 16, 18] For instance, viral vectors can stop working because of clumping or oxidation, and RNA treatments need clever ways to deliver them.
AI is changing formulation: Artificial intelligence is becoming a powerful tool in drug formulation.[19, 20, 22] AI-powered platforms can predict which excipients will work best with a particular active ingredient, making the formulation process much quicker.[19, 20, 22] This is super helpful for problems like poor solubility, which affects a large percentage of drugs in development.[20]
Investors are looking closer: Investors are paying more attention to how companies handle CMC.[6, 7] A good CMC plan makes a project less risky for investors, but CMC delays can hurt a company's value.[6, 7] This means that CMC leaders are under more pressure to create a strong "CMC story" to get money.
3. Problems and Solutions
These trends create both opportunities and problems for CMC and drug product development leaders. Here are some of the main problems and how people are solving them:
Challenge: Not enough in-house resources. Lots of biotech companies, especially smaller ones, don't have enough internal staff or know-how. They might not have a dedicated drug product (DP) team, or their small team is swamped with many projects.
Solution: Team up strategically. Working with a special formulation development company can help fill these gaps. These partners can become an extension of your team, not just doing the work but also giving smart advice. A good partner thinks ahead, focuses on solutions, and has deep scientific and regulatory knowledge.
Challenge: New types of treatments are complex. Making formulations for new therapies like viral vectors and RNA needs a different approach than for traditional biologics. In-house teams might not have the specific experience to handle these tricky situations.
Solution: Get help from experts. It's key to outsource to a partner with deep technical knowledge in these new areas.[21] This might include small workshops, in-depth sessions, and custom support to help your team learn the ropes.
Challenge: Need to move fast. There's huge pressure to get to the Biologics License Application (BLA) or Investigational New Drug (IND) stage quickly, especially for well-funded, fast-track companies.
Solution: Optimize things at the same time and use smart prediction tools. To speed things up, companies are optimizing the cell line, process, and formulation all at once. Using AI for stability prediction and data-driven formulation design can also help get a strong, ready-for-market formulation quicker.[20]
Challenge: Bringing on new partners is tough. For medium-sized biotech companies with established ways of working, bringing in a new vendor can be slow and clunky, often needing a clear reason for the purchase.
Solution: Try pilot projects and show clear value. To get started, a new partner can offer to take on a specific, tough project, like a new type of treatment or a stability problem. A "proof through pilot" approach, where the partner shows results on a small scale before going big, can build trust and prove their worth without major hassle.
4. How Leukocare Can Help with These Problems
Leukocare can directly help with these problems. We work with deep scientific expertise, a proactive partnership model, and the latest technology.
If you're a fast-track biotech leader, we have a smart formulation platform with AI for stability prediction to speed up your path to BLA. We work closely with your CMC professionals, giving you fast, reliable, and forward-thinking solutions.
If you're a small biotech with limited in-house resources, we offer clear communication and organized processes. We're a proactive partner, providing data-driven insights and hands-on support to help you build a strong CMC story for investors and regulators.
If you're a mid-size biotech looking for a new partner, we offer a low-risk way to start. We can handle specific challenges, like lyostability or a new type of treatment, and show our value with a pilot project. Our aim is to support your internal DP team, not take their place.
If you're a pharma company working on a new type of treatment, we give you the deep technical expertise and custom support you need to handle uncertainty. Through workshops, deep dives, and a partnership approach, we help you build your internal knowledge and make smart regulatory decisions.
For our CDMO partners, we act as a smooth, behind-the-scenes formulation team. We make sure projects run smoothly, stay loyal to the CDMO relationship, and offer a practical, adaptive approach.
5. What We Offer Our Clients
Our value is really about giving our clients confidence and a clear way forward. We offer:
Decisions based on data: Our formulation methods are designed to give you the data and insights for strong decision-making, whether it's for your internal plans or regulatory filings.
Fast and reliable: We get how tight deadlines are in drug development, and we offer fast, dependable service to help our clients hit their ambitious timelines.
Strategic partner: We don't just do the work; we're a strategic co-pilot, offering proactive solutions and a deep understanding of the science and regulations.
Custom expertise: We offer specialized expertise for the unique challenges of new types of treatments, making sure our clients have the support to innovate confidently.
By understanding what's happening now and trying new things, biotech leaders can successfully handle the complexities of formulation and get innovative treatments to patients faster.
6. FAQ
Q: What's the biggest challenge in formulation development right now?
A: One of the biggest challenges is how complex new drug types are, like viral vectors and RNA therapies.[15, 18] These need special knowledge and formulation strategies that are different from traditional biologics.[16]
Q: How is AI affecting formulation?
A: AI is speeding up formulation development by predicting the best formulations and cutting down on lots of trial-and-error.[19, 20, 22] This can save a lot of time and money, especially with compounds that don't dissolve well.[20]
Q: Why is a strong CMC strategy so important for biotech startups?
A: A strong CMC strategy is key for getting investor money and getting through the regulatory approval process.[6, 7, 23] It shows a clear plan for making a safe, consistent, and high-quality drug, which makes the project less risky for investors and regulators.[23, 7]
Q: What should you look for in a formulation development partner?
A: Look for a partner with deep scientific and regulatory expertise, a proactive and collaborative approach, and experience with your specific type of molecule or problem.[24, 25] They should be a strategic partner, not just someone who does tasks.[9]
Q: How can you justify bringing a new formulation partner into your company?
A: Focus on a specific need your current partners can't handle, like a new type of treatment or an ongoing stability problem. Suggesting a pilot project is a low-risk way to show the new partner's value and build trust in your company.
