Upstream Process Development
In the realm of biologics, the journey from discovery to market-ready product demands meticulous attention to detail and a robust understanding of upstream processes. At APC, we specialize in providing tailored Upstream Process Development services meticulously crafted to accelerate your biologics development journey.
Our approach to upstream process development is rooted in a holistic understanding of biologics production and of how what happens upstream can impact on the performance of subsequent downstream operations. From cell line development to media optimization and bioreactor scale-up, we leverage cutting-edge technologies and proven methodologies to ensure the seamless progression of your biologics program. With a team of seasoned scientists and engineers, we bring extensive expertise across a wide range of upstream operations. Whether it's fermentation, cell culture, or protein expression, we have the knowledge and experience to optimize each step of the upstream process.
We thrive on solving complex challenges inherent in biologics development. Utilizing advanced analytics, Process Analytical Technology (PAT), predictive modeling, statistical analysis, and high-throughput screening, we identify and implement innovative solutions to enhance cell productivity, improve product quality, and optimize process efficiency.
Throughout the upstream process development journey, we prioritize transparent collaboration and communication. Working closely with your team, we provide regular updates, share insights, and address challenges collaboratively to ensure alignment with your project goals and timelines. This transparent approach is underpinned by our first-in-class CMC digitalization platform, iAchieve, - providing you with real-time data tracking and curated insights. This streamlines decision-making, facilitates easier tech transfer, and ensures an ability to efficiently answer any CMC-related questions from the regulatory authorities - ultimately accelerating your path to market.