addressing-opalescence-in-bispecific-antibody-solutions
Opalescence can hinder the stability and clarity of bispecific antibody solutions, creating significant CMC challenges. Are you seeking effective strategies to ensure robust formulation development for your advanced biologics? Learn how to tackle this critical issue.
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The Formulation Puzzle: Navigating CMC in a Shifting Biotech Landscape
FAQ
Current Situation
Typical Market Trends[8]
Current Challenges and How They Are Solved[23]
How Leukocare Can Support These Challenges[21, 29]
Value Provided to Customers
The Formulation Puzzle: Navigating CMC in a Shifting Biotech Landscape
The journey from a promising molecule to an approved biologic is a marathon, not a sprint. For leaders in Chemistry, Manufacturing, and Controls (CMC) and Drug Product (DP) development, this journey is becoming more complex. The biopharmaceutical market continues to grow, with projections showing an increase from $453.7 billion in 2025 to $921.5 billion by 2034.[1, 2] But this growth is set against a backdrop of economic pressure and evolving scientific frontiers.
Current Situation
Today’s biotech environment is a mix of good and bad. The biopharmaceutical market is expanding, with lots of demand for advanced biologics and targeted therapies, but getting funding has become harder. Since the peak of 2021, the biotech sector's value has fallen significantly, creating a funding squeeze that especially hurts early-stage companies.[1, 2] Investors are now focusing on late-stage assets with clear commercial paths, leaving preclinical innovators to compete for fewer resources.[3] This "tale of two cities" means that while some companies secure large funding rounds, many others face a tough reality.[3, 4]
This financial pressure forces companies to do more with less, prioritizing lead programs and often reducing staff.[3] The pressure to reach a Biologics License Application (BLA) faster and with more certainty has never been greater.[3, 4, 6] A BLA submission requires extensive data on the product's safety, efficacy, and manufacturing processes, making robust CMC data super important.[7]
Typical Market Trends[8]
Several key trends are shaping the decisions of CMC and DP leaders:
Increased Outsourcing: Outsourcing has become a common practice in the biopharmaceutical industry. By 2022, nearly 87% of biopharmaceutical companies were outsourcing at least some of their activities, a figure that continues to grow.[9] The global biotechnology outsourcing market is projected to grow at a compound annual growth rate (CAGR) of 9.4% from 2024 to 2030.[9] This is especially true for specialized areas like formulation development, where contract development and manufacturing organizations (CDMOs) offer expertise that may not be available in-house.[10, 11, 12]
Focus on Advanced Therapies: The industry is moving towards more complex modalities like viral vectors, mRNA therapeutics, and cell and gene therapies. These therapies present unique formulation challenges, such as ensuring stability and managing immunogenicity.[13, 16] For instance, mRNA-LNP formulations face hurdles with stability and degradation.[14, 15]
Rise of AI and Predictive Modeling: Artificial intelligence (AI) and machine learning are transforming formulation development. These technologies can predict drug stability, solubility, and other properties, which helps to reduce experimental workload and accelerate timelines. AI is being used to analyze large datasets to identify patterns that can predict how different formulations will affect a drug's properties.[17, 18, 19, 30]
Regulatory Scrutiny: Regulatory agencies like the FDA and EMA are placing greater emphasis on a deep understanding of the product and the manufacturing process. This requires comprehensive documentation and a clear rationale for all formulation and process decisions.[20, 21, 29] A well-executed CMC strategy is a big help that can speed up the path to patients.[22]
Current Challenges and How They Are Solved[23]
CMC and DP leaders face several persistent challenges:
Limited Internal Bandwidth: Many small and mid-size biotech companies operate with lean teams. They may have deep scientific knowledge but lack the internal resources to manage all aspects of CMC and formulation development. This is especially true for virtual and early-stage biotechs that outsource most of their operations.
Finding the Right Partner: With the rise of outsourcing, choosing the right CDMO partner is super important. The wrong partner can lead to delays, poor-quality data, and a lack of strategic input. Companies need partners who act as collaborators, not just vendors, bringing proactive ideas and a deep understanding of the science.
Navigating New Modalities: As companies venture into new therapeutic areas, they often encounter unfamiliar formulation challenges. For example, a large pharma company with established processes for monoclonal antibodies may struggle with the complexities of a new viral vector program. They need specialized expertise to de-risk these new ventures.
Pressure to Accelerate Timelines: The pressure to get to the clinic and to market quickly is huge. This often means optimizing the cell line, process, and formulation in parallel.[24] Accelerated formulation strategies are essential to keep development on track without sacrificing quality.
These challenges are being met with new approaches.[24] Companies are seeking better partnerships with CDMOs, moving beyond transactional, fee-for-service models. The use of platform technologies and predictive modeling helps to make development less risky and accelerate timelines.[26, 27] A Quality by Design (QbD) approach, which involves building quality into the product from the beginning, is also becoming common now.[28]
How Leukocare Can Support These Challenges[21, 29]
Leukocare is here to help with these challenges. Our approach is built on a strong base of scientific know-how, cool tech, and a teamwork approach.
For the Fast-Track Biotech Leader facing a lot of pressure from their board, we offer a path to a faster BLA. Our Smart Formulation Platform, which combines AI-based stability prediction with our deep formulation expertise, helps to create a strong formulation that's ready for regulators. We work as a co-pilot, giving you the data and insights to make confident choices.
For the Small Biotech with CMC Understanding but no internal DP team, we act as a part of their team. We provide a clear point of contact, clear, upfront communication, and structured processes that match what investors and regulators need. We focus on providing genuine understanding, not just buzzwords.
For the Mid-size Biotech hitting limits with existing partners, we offer a way to break in with a pilot project focused on a specific challenge, such as a new modality or a lyostability issue. We show how we can support their internal DP teams without competing with them, delivering results first and then scaling the partnership.
For the Pharma company tackling a new modality, we provide the specialized knowledge they need. Through deep dives, workshops, and tailored support, we help them build internal know-how and make sound regulatory decisions, even with limited internal experience in the new area.
For the CDMO looking for a network partner, we act as a neutral, external formulation expert. We fit right into their offering, providing reliable, formulation development based on solid science without getting in the way of their client relationships.
Value Provided to Customers
We help make things less risky and faster for a stable, effective, and marketable drug product. We provide our partners with:
Data-driven confidence: Our predictive modeling and formulation intelligence provide the data needed to make good decisions and build a strong CMC story for investors and regulators.
Real partnership: We don't just execute; we collaborate. We share our ideas and insights, acting as a true partner in solving complex formulation challenges.
Speed and reliability: Our accelerated formulation strategies help to get products to the clinic faster without cutting corners. We deliver reliable, high-quality results that our partners can trust.[24]
Flexibility and adaptability: We adjust our approach to the specific needs of each partner, whether it's a small virtual biotech or a large pharmaceutical company.
By sticking to these main ideas, we help our partners handle the complex parts of modern drug development and bring innovative therapies to patients who need them.
FAQ
What is the current funding environment for biotech companies?
The biotech funding environment in 2024 and heading into 2025 is picky. While overall investment in the biopharmaceutical market is projected to grow, venture capital is more and more focused on late-stage companies with clear paths to commercialization.[3, 4, 6] Early-stage and preclinical companies are finding it tougher to get money.[3, 4] This has led to a "funding winter" for some, with many companies saving cash and focusing on their most promising programs.[3, 4]
What are the main CMC challenges for new modalities like viral vectors and mRNA?[3]
New modalities come with their own CMC challenges. For viral vectors, challenges include manufacturing scalability, ensuring product quality and consistency, and developing stable formulations. For mRNA therapeutics, key challenges include the natural instability of RNA molecules, managing the immunogenic response, and developing effective delivery systems like lipid nanoparticles (LNPs).[13, 16] Both require specialized analytical methods and deep formulation expertise to ensure a safe and effective product.[14, 15]
How is AI changing formulation development?
AI and machine learning are having a big impact on formulation development by making it faster and more predictive. These technologies can analyze large datasets to predict drug properties like solubility and stability, find the best ingredients, and predict how they'll break down.[17, 30] This data-driven approach means fewer experiments needed, saving time and resources.[18, 19, 31]
Why is outsourcing formulation development a growing trend?[18, 19]
Outsourcing formulation development is growing because it allows biopharmaceutical companies, especially small and mid-sized ones, to get specialized expertise and technology without the high cost of building and maintaining these capabilities in-house. CDMOs that specialize in formulation can offer proven quality systems, regulatory knowledge, and experience with a wide range of molecules and challenges.[10, 11, 12] This allows sponsor companies to focus on their core competencies while using the expertise of a dedicated partner.[11]
