Partnering in Drug Development
Solving Functional Testing Challenges Virtually
Client Overview: A biotech company focused on developing novel protein biologics, designed de novo using cutting-edge protein design software like AlphaFold 3, encountered a significant bottleneck at the functional testing stage. While they could rapidly design new protein structures targeting a key cell surface receptor involved in diabetes, their progress stalled when it came to testing the functionality of these biologics. The company aimed to remain a virtual dry lab to avoid the high costs associated with hiring personnel and acquiring laboratory space, while still advancing their therapeutic pipeline efficiently. However, the inability to conduct functional testing in-house limited their ability to move forward.
Challenge: The client needed to purify and test their lead biologic proteins for affinity to their target molecule but lacked wet lab infrastructure and scientific personnel to carry out the necessary screens and purification. They also wanted to remain virtual, making it essential to find cost-effective and efficient ways to access academic lab resources and expertise for protein purification and Surface Plasmon Resonance (SPR) affinity testing.
Solution: GOTBio played a pivotal role in enabling the client to meet their goals while maintaining a virtual structure. Here’s how we facilitated their success:
- Connecting with Expert Resources:
- GOTBio connected the company to university wet lab resources and expert personnel who specialized in protein purification. This allowed the client to purify their lead proteins and determine their affinity for the target molecule.
- After three rounds of protein design and affinity testing, facilitated by GOTBio’s strategic partnerships, the client identified a biologic that met their criteria for advancement.
- Acting as a liaison, we negotiated the necessary agreements and established a laboratory service contract to ensure the protection of the company’s intellectual property while allowing the testing to proceed seamlessly.
- Strategic Support for Functional Testing:
- GOTBio guided the client through in vitro functional testing using a cell-based assay, where the target molecule was expressed, allowing them to evaluate the biologic’s efficacy.
- We further assisted the company in securing intellectual property protection by connecting them with a top-tier law firm.
- PreIND Meeting Preparation:
- GOTBio provided guidance on preparing for a preIND (Investigational New Drug) meeting, positioning the client for future regulatory discussions and strategic milestones.
Outcome:
- Cost Savings: By remaining virtual and leveraging academic lab resources for protein purification and affinity testing, the client minimized overhead expenses. They avoided the costs of hiring full-time staff or setting up in-house facilities, reinvesting savings into further strengthening their intellectual property portfolio.
- Accelerated Development: The client’s ability to access established wet labs and experts accelerated their development timeline, achieving key milestones faster than if they had built their own lab infrastructure.
- Successful Fundraising: Following the successful rounds of protein design, affinity testing, and cell-based functional assays, the company raised substantial funding, allowing them to advance their biologic candidate into the next phase of development.
Conclusion: Through GOTBio’s strategic connections and expert guidance, the client successfully advanced their de novo-designed protein biologic while remaining virtual. GOTBio’s approach allowed the company to save time, reduce costs, and secure critical IP, all while positioning the biologic for further clinical development and future growth.
