liquid-formulation-development-biologics
In today's high-pressure biotech landscape, every decision in drug product development impacts success and timelines. Discover how optimizing liquid formulation development for biologics early can be the key to de-risking your program and achieving a faster path to BLA.
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FAQ
Current Situation
Typical Market Trends
Current Challenges and How They Are Solved
How Leukocare Can Support These Challenges
Value Provided to Customers
Stabilizing Success: Thinking about Formulation in Today's Biotech World
For anyone in CMC and Drug Product Development, there's constant pressure. The path from discovery to a commercial-ready product is long and expensive, often taking a decade or more [1, 25]. Timelines are tight, investor expectations are high, and the science itself is more complex than ever. Every decision matters in this environment, especially those made early on. Formulation, once seen as a late-stage hurdle, is now seen as a key part of a successful development program. Getting it right from the start can be the difference between a fast track to BLA and a costly delay.
Current Situation
The biotech funding landscape has seen shifts. After a dip, investment is showing signs of recovery in 2024, but investors are more selective [4, 7]. They favor companies with clinical-stage assets over preclinical platforms, putting pressure on teams to show progress and reduce risks as early as possible [4, 7]. This financial reality affects everyone, from the virtual, well-funded "Fast-Track Biotech" racing toward a Biologics License Application (BLA) to the "Small Biotech" with a promising molecule but limited internal resources.
Mid-size biotechs with established pipelines face their own constraints, often hitting bandwidth limits or struggling with legacy partnerships when tackling new modalities. Large pharma companies have lots of money, but they still face challenges. They often face internal uncertainty and skill gaps when exploring new areas like viral vectors or RNA therapies [27, 8]. At the same time, Contract Development and Manufacturing Organizations (CDMOs) are also key players, looking to offer more services to keep clients happy and get projects done faster [10, 11, 24, 29].
Typical Market Trends
Several key trends are shaping the market. The industry's move toward advanced and novel therapies, including cell and gene therapies, ADCs, and RNA-based medicines, brings new stability and delivery problems that need special formulation know-how [8, 12, 13, 27]. There's also more outsourcing, not just for extra hands, but for specific skills [14]. Companies are seeking partners who can act as strategic collaborators rather than just executing orders.
Tech's a bigger deal now too. The use of artificial intelligence and predictive modeling in formulation development is becoming more common, helping to analyze complex data sets and forecast stability with greater accuracy [16, 17, 18]. This data-driven approach shifts formulation from old trial-and-error ways to something more predictable and efficient [19].
Current Challenges and How They Are Solved
Everyone in CMC and drug product leadership faces the same basic pressures: time, risk, and money. But how those pressures show up depends on the company.
For the Fast-Track Biotech Leader, their biggest headache is the intense time crunch and no wiggle room for mistakes. With everything outsourced, they are wary of vendors who don't think strategically. They need a proactive partner who brings solutions and scientific excellence to the table, acting as a co-pilot on the rapid journey to BLA. The solution lies in finding a partner that can provide data-driven formulation tailored to aggressive timelines [20].
The Small Biotech with no internal drug product team struggles with limited bandwidth and the need to build a compelling CMC story for investors. They may have had poor experiences with academic-style service providers and needs a partner who talks straight, works on their own, and delivers solid results without a fuss [14].
Mid-size Biotech Directors often find their internal ways and current vendor relationships are too stiff for new challenges. Bringing on a new partner through purchasing can be a slow, painful process. They need a good reason to try someone new, maybe for a tough challenge with a new type of therapy or when they need very specific expertise. The solution is often a pilot project to test a new partnership, proving its value before scaling [21].
In Large Pharma, the challenge is often internal. When working on a new type of therapy like viral vectors, internal teams might not have specific experience, which makes the development plan unclear. They need a partner who can offer specific expertise, case studies, and custom materials to help with internal decisions and reduce the risk of the new project [23].
CDMOs acting as Network Partners have to meet client requests for formulation services without setting up their own internal team. They need a reliable, neutral formulation partner who can work seamlessly in the background, executing projects without creating coordination burdens or loyalty risks [10, 24].
How Leukocare Can Support These Challenges
Addressing these distinct challenges needs a custom approach to formulation. Leukocare is set up to help with these different needs by mixing advanced tech with a collaborative approach.
Our Smart Formulation Platform, which uses AI-based stability prediction, is designed to accelerate development and provide a clear, data-driven path forward [16, 18]. This really helps Fast-Track Biotech Leaders who need speed and reliability. For Small Biotechs, we provide structured processes and clear communication, acting like an extension of their team to give solid data packages for investors and regulators.
For Mid-size Biotechs, we offer a way to get started by solving specific, tough problems, like those with lyostability or new therapy types. We show our value through focused pilot projects, showing how we can support internal teams without replacing them. When Pharma is working on a new type of therapy, our deep technical understanding of vectors and ADCs means we can be a real sparring partner, offering mini-workshops and specific insights to fill knowledge gaps. And for CDMOs, we work as a quiet and loyal partner, handling the formulation work ourselves and making sure everything goes smoothly for their client.
Value Provided to Customers
The main goal is to get promising therapies moving forward efficiently and safely. By focusing on formulation from the beginning, companies can gain significant advantages.
For our clients, this means real value:
A faster path to BLA with a formulation designed for regulatory success.
Decisions based on data that reduce development risks, especially for pricey and complex molecules.
Trustworthy expertise for tricky, specific problems, so internal teams can focus on their main jobs.
Confidence to try new therapy types, guided by a partner with real-world data and experience.
Smooth project work that builds stronger client relationships and avoids common outsourcing headaches.
Good formulation is more than just a stable product; it's a smart move that can save time, cut risk, and boost a program's overall value. Picking the right partner for that is one of the biggest decisions a CMC leader can make.
FAQ
When should we start thinking about advanced formulation?
It's best to think about formulation during pre-clinical stages [1, 25]. Early formulation work helps reduce risks for clinical candidates by fixing stability problems right away [14]. Getting ahead ensures the formulation changes with the product, stopping delays in later clinical phases when changes get tougher and more expensive to make [26].
How can we reduce the risk in developing a new or complex therapy type?
Reducing risk for new therapy types like viral vectors or mRNA therapeutics needs special knowledge [27, 8]. Working with formulation experts who really get these specific challenges is key [28]. Using data-driven and predictive modeling can help spot problems early and create custom solutions, making the path through development and regulatory review clearer [19].
What makes a good formulation partner?
A good formulation partner works with you, not just for you [11, 29]. They should be proactive, focus on solutions, and talk clearly. Look for a team with strong science and regulatory know-how, who can work on their own to lighten your team's load, and are flexible enough for your project [30, 31].
How can we ensure smooth tech transfer and collaboration with a CDMO?
Smooth teamwork needs clear communication, clear processes, and everyone on the same page about goals. When working with a specialized formulation partner and a CDMO, make sure the formulation provider can work quietly and loyally, respecting the main relationship between the biotech and the CDMO. A good formulation partner will give the CDMO a solid, transferable process, cutting down on friction and coordination work [20].
What does AI do in formulation, and how does it really help?
AI in formulation uses machine learning to look at big data, predict stability, and optimize formulations way more efficiently than old methods [16, 18]. This really helps by cutting down experiments, speeding up timelines, and finding insights into complex interactions between molecules and excipients [19]. It allows for a more organized, data-driven way to develop stable and effective drug products [17].
