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Developing new biologics, especially complex injectable antibodies, faces unique formulation challenges like high viscosity. Learn how to navigate the evolving biopharma landscape and accelerate your drug to market.
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Navigating the Evolving Landscape of Biopharmaceutical Development
Current Situation
Typical Market Trends
Current Challenges and How They Are Solved
How Leukocare Can Support These Challenges
Value Provided to Customers
FAQ
Navigating the Evolving Landscape of Biopharmaceutical Development
Getting a new biologic to market is tough and full of challenges. For leaders in CMC and Drug Product Development, there's huge pressure to move fast without cutting corners. Let's look at where biopharmaceutical development stands, what's trending, and the obstacles companies run into. We'll also see how a dedicated partner can help clear these hurdles and add value all the way through.
Current Situation
The biopharmaceutical industry is changing fast.[1] On one hand, we're seeing a burst of innovation, with new options like cell and gene therapies and RNA-based drugs offering hope for conditions that used to be untreatable.[2, 25, 26] At the same time, it's getting tougher to get funding.[4, 5] While venture capital funding for life sciences looks like it's bouncing back in 2024, investors are leaning towards more established companies with products further along in development.[5, 6] This makes things tough for early-stage and virtual biotech companies, who often work with limited cash and tight deadlines.
Outsourcing is now a go-to strategy for survival and growth. Lots of biotechs now rely on contract development and manufacturing organizations (CDMOs) for everything from process development to manufacturing.[8] This lets them focus on what they do best: finding new drugs.
Typical Market Trends
Here are some trends shaping the biopharma market:
Shift to specialized outsourcing: Companies are increasingly turning to CDMOs for specialized expertise, especially for complex biologics and advanced therapies.[9]
Rise of biologics and new modalities: Biologics, including monoclonal antibodies, now represent a big chunk of new drug approvals and sales.[10, 11] There's also growing interest in RNA-based drugs and viral gene therapies, which bring their own unique manufacturing and formulation challenges.[12, 13]
Focus on speed and efficiency: The pressure to accelerate timelines and cut costs is constant.[14, 15] This has led to the adoption of new technologies like continuous manufacturing and data analytics to improve efficiency.[9]
Flexible and scalable solutions: Companies need partners who can adapt to changing demands and scale production as a product moves through clinical trials.[9]
Current Challenges and How They Are Solved
Even with all the opportunities, getting to market isn't easy. Here are some of the main challenges and how companies are tackling them:
Formulation and Stability: Biologics are large, complex molecules sensitive to their environment.[16] Keeping them stable through manufacturing, storage, and administration is a big hurdle.[17, 19] A bad formulation can cause clumping or breaking down, which hurts safety and how well it works.[17, 19] Companies are tackling this with advanced formulation development, like using predictive modeling and high-throughput screening to find the best conditions.
Navigating the Regulatory Landscape: Regulatory requirements for biologics are complex and constantly evolving.[1] Successfully getting through Investigational New Drug (IND) and Biologics License Application (BLA) submissions means really understanding what agencies like the FDA expect.[21] Companies are handling this by talking to regulators early on and teaming up with partners who know the ropes.[2, 25, 26]
Outsourcing Complexities: Outsourcing helps a lot, but it also brings challenges like communication gaps, feeling less in control, and data security risks. Good outsourcing relationships rely on clear talks, trust, and everyone being on the same page.
CMC for Advanced Therapies: Cell and gene therapies have special Chemistry, Manufacturing, and Controls (CMC) challenges because their starting materials vary and their manufacturing is complex.[2, 25, 26] They're solving these by developing strong manufacturing processes and advanced ways to analyze things, making sure product quality and consistency are top-notch.[27]
How Leukocare Can Support These Challenges
Leukocare helps companies get through these challenges by offering specialized formulation development. Our approach is built on a deep understanding of biologic science and a commitment to working closely with our clients.
For the Fast-Track Biotech Leader: We offer a smart formulation platform and AI-based stability prediction to accelerate the path to BLA. Our team of seasoned CMC professionals works as a strategic co-pilot, providing proactive, solution-oriented partnership.
For the Small Biotech with CMC Understanding: We provide a clear point of contact, proactive suggestions, and rapid turnaround times. Our structured processes and documentation are designed to meet the needs of both investors and regulatory authorities.
For the Mid-size Biotech: We can help you break in by addressing specific challenges like new modalities or lyostability. We support your internal DP teams, we don't replace them. We believe in a "pilot first, scale second" approach, letting the results speak for themselves.
For Pharma Tackling a New Modality: We provide deep technical know-how in areas like vectors and ADCs. We offer mini-workshops, deep dives, and tailored support materials to help build internal expertise.
For the CDMO as a Network Partner: We act as a neutral, external formulation partner. We offer fully independent execution with no back-and-forth, and we are loyal to the CDMO relationship, with no client poaching.
Value Provided to Customers
We provide value by offering data-driven formulation solutions custom-made for each client and their molecule.
For the Fast-Track Biotech Leader: We help you reach BLA faster with a formulation designed for regulatory success.
For the Small Biotech with CMC Understanding: We provide structure, speed, and substance, driven by data and delivered with reliability.
For the Mid-size Biotech: We solve complex problems using our modeling platform and formulation intelligence to deliver results you can trust.
For Pharma Tackling a New Modality: We guide your modality path with real data, real expertise, and tailored formulation design.
For the CDMO as a Network Partner: We act as your silent, seamless, and science-backed formulation team, always loyal to your client relationship.
FAQ
What are the biggest challenges in biologic drug formulation?
The main challenges are keeping complex protein structures stable, stopping them from clumping and breaking down, and making sure the drug stays strong throughout its shelf life.[16]
How important is the formulation for a successful IND or BLA submission?
The formulation is super important.[21] A well-developed formulation lays the groundwork for a strong CMC section in your submission, showing off product quality and consistency.[28] The FDA needs detailed info on the drug's makeup, how it's made, and quality control.[29, 30]
How can outsourcing help smaller biotech companies?
Outsourcing lets smaller companies get specialized expertise and cutting-edge tech without big upfront costs.[22, 31, 7] It helps them focus on what they do best: finding and developing drugs.[8]
