At GBI Bio, we employ a rigorous analytical approach to biopharmaceutical drug development and GMP manufacturing, prioritizing efficiency, speed, flexibility and quality through standardized methods. With over 30 years of experience in the CDMO space, we possess high analytical expertise that enables us to streamline workflows, reduce development time, and minimize risk. Through our rapid analytics framework, we harness insights from hundreds of assays performed and continuously refine our methods to deliver reliable, high-quality data to our clients.
Leveraging Rapid Analytics for Efficient Drug Development
Our analytical framework is built on platform strategies that utilize thoroughly validated methods. This systematic approach optimizes resources and mitigates the risks associated with custom and client specific assay development. By applying rapid data analysis, we identify patterns from previous projects, translating these insights into effective solutions to new challenges. Our extensive library of standardized methods serves as a foundation, allowing for tailored adjustments specific to project requirements. This methodology results in reduced turnaround times, lower risks, and enhanced consistency and reliability of results.
Preclinical Studies Support: We employ rapid analytics to generate critical materials and data for materials used in toxicological studies and clinical studies, ensuring alignment with clinical requirements and supporting timely progression through the preclinical phase.
Data Integration and Analysis: Our advanced analytics tools facilitate effective integration of data across all preclinical stages. This data-driven approach supports informed decision-making and strengthens regulatory filings, including IND applications.
Research Cell Bank to GMP Commercialization: GBI Bio maintains control over the entire process, from research cell banks to GMP commercialization. Our specific assay development, qualification and validation are crucial for successful Biologics License Application (BLA) filings. By implementing rigorous validation and quality control protocols at each phase, we provide a streamlined pathway from early-stage development to commercial readiness.
This comprehensive analytical approach ensures that promising drug candidates transition efficiently from research to clinical application, thereby accelerating the delivery of new therapies to the market.
Efficiency Through Platform Strategies
Efficiency is fundamental to our analytical framework. We continuously enhance our processes by analyzing insights from previous projects, refining our methodologies for new clients. Key components of this strategy include:
- Method Adaptability: We assess whether standardized methods from our extensive database can be adapted to new projects, minimizing the need for new assay development.
- Standardization for Speed and Quality: The standardization of analytical methods enables faster results without compromising accuracy. Our validated methods ensure consistency across projects, effectively reducing development time and expediting market entry.
- Reduced Development Time: By leveraging robust methods and existing data libraries, we significantly decrease the time required for method development, reallocating resources toward project-specific optimization.
- Data Integration: Continuous data integration enhances our methods and overall analytical quality, facilitating iterative improvements in our approach.
Balancing Speed, Risk, and Quality
We understand that speed, risk management, and quality are interdependent in successful drug development. Our analytical processes maintain a strong commitment to quality while leveraging rapid analytics:
- Standardized, Rigorously Tested Methods: Even as we accelerate timelines, our use of validated methods guarantees consistency and reliability of results.
- Real-Time Adjustments: Continuous evaluation and refinement of method performance allows our teams to implement real-time adjustments, ensuring adherence to high standards of accuracy.
- Continuous Training: Ongoing training for our staff ensures they remain adept in the latest technologies, preserving quality while enhancing efficiency.
Summary
Rapid analytics play a pivotal role in de-risking platform strategies within biopharmaceutical drug development. At GBI Bio, we leverage these methodologies borne from decades of analytical experiences to facilitate the transition from candidate optimization to clinical trials, ultimately streamlining market entry for new therapies. Our dedication to standardized methods, comprehensive data integration, and real-time adjustments ensures an optimal balance of speed, risk management, and quality.
For ongoing updates on GBI Bio’s innovations in analytical assays, connect with us on LinkedIn and our website. For collaboration opportunities or service inquiries, please contact us directly—together, we can advance the future of biopharmaceutical innovation.
Hipul Rao
Sr. Director, Protein Characterization, Quality Control, Microbiology
Hipul Rao is a distinguished professional serving as the Sr. Director of the Analytical Department at GBI Biomanufacturing, where he orchestrates a dynamic team of scientists across various disciplines, including Protein Characterization, Quality Control, and Microbiology. With over 22 years of invaluable executive experience in the Bio/Pharmaceutical industry, Hipul is a seasoned expert at the forefront of advancing drug discovery, design, developability, and cell line development. In his role, Hipul is the driving force behind GBI’s technical analytical strategy, overseeing the entire spectrum of the GBI Biomanufacturing portfolio from early development to commercial production. His responsibilities encompass a wide array of critical functions, including protein characterization, process optimization support, complex method developments, technology transfer, quality control, phase-appropriate qualification/validations, API release, in-process, finished product, and stability sample analysis End-to-End products pipelines. He plays a pivotal role in ensuring GBI’s strong innovation focus and scientific expertise depth are maintained, fostering technological developments, and collaborating closely with clients to design and deliver solutions that align with their program needs.
