Streamlining the development of novel compounds from vaccines to oncolytic viruses and Cell and Gene Therapies, faces numerous obstacles. The absence of effective process development strategies, CMC know-how, and suitable production technologies are key roadblocks towards clinical development and product commercialization.
bespark*bio resolves these bottlenecks by developing innovative and effective production technologies. Our process development solutions combine best-in-class bioprocessing expertise and state-of-the-art technology with machine-learning approaches and contemporary digitalization. The result? Accelerated development timelines, enhanced process understanding, and reduced costs.
One hallmark feature of our process development approach is the use of modular building blocks, meticulously developed and optimized through rigorous testing. These blocks encompass a spectrum of experimental techniques, protocols, and analytical methodologies and eliminate the need for labor-intensive selection of process technologies, parameters, and equipment.
The building blocks can seamlessly be integrated into comprehensive process streams and complete framework technologies. Our frameworks facilitate swift and flexible process adaptation, serving as the perfect launch pad for your customized development project. Data derived from framework development and empirical observations fuel our comprehensive data-models, further simplifying customer specific adaptation.
By leveraging this prior knowledge, we replace arduous trial-and-error development by educated decisions, significantly accelerating your project’s timeline while minimizing the risk of experimental setbacks.
In a data-rich environment harnessing the power of advanced analytics is no longer a luxury, it‘s a necessity. That‘s why we employ data-driven modeling and machine learning techniques to unlock valuable insights from process data.
With process simulation and hybrid modeling at the helm, we optimize your processes, leading to improved efficiency, enhanced product quality, increased process understanding and reduced costs.
Whether you‘re looking to streamline manufacturing operations, accelerate drug development, or enhance product yield, our expertise in data-driven solutions ensures that you remain at the forefront of innovation.
In today‘s competitive landscape, sound process understanding, increased process robustness and scalability are essential. That‘s where Quality by Design comes into play. By implementing these methodologies, we design quality into every step of a process from the outset. Rather than relying on trial and error or reactive problem-solving, QbD enables us to proactively design, optimize, and control your processes to meet your specifications.
When using classical approaches, implementing QbD can be a time-consuming endeavor. Not with us. By leveraging our Framework technologies and associated data models, we kick-start QbD implementation.
Digital transformation offers unparalleled advantages for process development. Our centralized data hub provides seamless data management, visualization, and analysis capabilities, optimizing workflows and boosting productivity across the board.
Real-time data accessibility empowers enhanced agility and efficiency in your development processes.
Whether it’s a complete end-to-end process development or the optimization of a single unit operation, we ensure that your journey from scientific breakthrough to clinical development and ultimately marketing authorization is guided by innovation and efficiency.
Our Framework-based development expedites your project, reduces development costs, and enhances process understanding.
When faced with bottlenecks beyond the reach of existing frameworks, we don‘t back down – we innovate. We‘re all about crafting novel solutions to those challenges, whether that means pioneering new framework technologies or creating bespoke framework-independent processes.
