Top 5 Ways that Portable CMC™ can Benefit your Antibody Development Program
It is no secret that venture capital (VC) funding for biotech start-ups has constricted significantly since its peak in 2021, yet the demand for monoclonal antibody and antibody-like therapies remains strong. This has led to a highly competitive market environment for biotech innovators seeking to move from seed funding into Series A. VC firms now seek more robust developability and manufacturability assessment data earlier in the lead selection process to mitigate risk. To generate this data, innovators often turn to contract development and manufacturing organizations (CDMOs) to move into the chemistry, manufacturing, and controls (CMC) development path. CMC development consists of cell line, process, and analytical development. Cell line and upstream development processes are focused on antibody lead selection and productivity. Downstream process development is focused on improving purity and yield in preparation for pre-clinical material supply and preparation for first-in-human drug substance manufacture, while analytical development works to improve product quality testing robustness. The traditional CDMO model, however, is not well aligned with the timeline and funding realities innovators face. Typically, a traditional CDMO partner will require innovators to begin clonal cell line development early on – a lengthy and expensive process. Traditional CDMOs also tend to require large up-front financial commitments for the full CMC process package, placing the innovator in a position of significant financial risk. Because of these factors, biotech start-ups often face a frustrating gap and misalignment of their needs for early feasibility data and financial freedom with a CDMO’s approach.
A New Approach for Rapid CMC Development and CGMP Clinical Material Supply
Addressing this gap for innovators taking the leap from discovery to clinic is what motivated Wheeler Bio to develop the Portable CMC™ platform – a paradigm shift from the traditional CMC process. This modular, pools-based, open-source, and cost-effective approach offers many advantages for biotech start-ups aiming to revolutionize antibody development. In this blog post, we will delve into the top 5 benefits a biotech start-up company’s antibody development program can experience through the Portable CMC™ platform.
1. Funding Alignment
Securing funding is a critical challenge for any biotech start-up. The Portable CMC™ modern antibody platform addresses this hurdle by aligning funding requirements with the program’s unique needs. The modular approach allows start-ups to break down the entire cell line, upstream and downstream development processes into manageable stages, enabling them to secure funding for each milestone achieved. This incremental funding model attracts potential investors and provides start-ups with a roadmap to demonstrate progress, build credibility, and secure sustained financial support.
2. Ease of Access
Typically in antibody development, a traditional CDMO requires a substantial upfront financial commitment, posing a formidable entry barrier for biotech start-ups and a significant financial risk. The Portable CMC™ platform presents an alternative approach that lowers this barrier to entry and significantly mitigates financial risk for the innovator. By employing a modular approach with milestone-based payments, start-ups can embark on their antibody journey one step at a time. This easier access translates to enhanced flexibility during feasibility assessment, allowing start-ups to allocate resources more strategically and focus on what matters most – advancing a potent, manufacturable, and scalable therapy to clinic.
3. Affordable Workflow
The Portable CMC™ platform redefines affordability in modern antibody development. By leveraging a pool-based workflow for antibody expression and production, innovators can defer clonal cell line development and instead utilize precious seed funds to generate early lead manufacturability assessment data – a crucial milestone for securing Series A funding. The platform’s transparent, all-inclusive, milestone-based pricing further ensures predictability and budgetary control. In a landscape where financial prudence is paramount, the Portable CMC™ platform empowers biotech start-ups with cost-efficient solutions, driving progress and innovation in antibody development.
4. Process Freedom
Flexibility in process development and manufacturing is vital for biotech start-ups aiming to differentiate their antibody programs. The Portable CMC™ platform empowers start-ups with the freedom to adapt and refine their processes with an open-source approach that allows clients to either manufacture phase 1 clinical material with Wheeler, or transfer to another CDMO where an existing investor relationship may exist. Start-ups can leverage their creativity to optimize manufacturing and controls, resulting in tailor-made solutions that enhance antibody production quality and efficiency.
5. Speed to Clinic
In the competitive biotech landscape, speed to clinic is paramount. The Portable CMC™ platform accelerates the journey from laboratory research to clinical trials. The pools-based workflow eliminates the time-consuming clonal cell line development process, allowing start-ups to bypass a significant bottleneck. This streamlined approach expedites the transition from lead candidate identification to clinical testing, enabling start-ups to seize early-mover advantages, secure intellectual property, and potentially bring life-saving therapies to patients faster.
The Portable CMC Platform Meets the Unique Needs of Biotech Start-ups
The Portable CMC™ platform emerges as a game-changer for biotech start-ups embarking on modern antibody development journeys. By aligning funding, providing easy access, offering affordability, enabling process freedom, and enhancing speed to clinic, this innovative approach revolutionizes the traditional CMC process. Biotech start-ups can now harness the power of the Portable CMC™ platform to accelerate their antibody development programs, optimize resource allocation, and bring novel therapies to the forefront of medical innovation, faster and more reliably.