Breakthrough Science:
7 Standout Achievements from APC
At APC, we pride ourselves on driving innovation and constantly reimagining process development in service of our clients. Ultimately, this means patients benefit from having quicker access to life-changing medicines. You could argue that we make breakthroughs every day in our labs, however, here are several that rise to the top and reinforce the innovative spirit behind what we do.
Self-Optimizing Bioreactors
Optimization of bioprocesses has traditionally been thought of as more art than science. We have developed a method to monitor 30 different bioprocess metabolites every 4 to 6 seconds. We then combine this information with a Model Predictive Control (MPC) architecture which enables a bioreactor to optimize itself.
Engineering Better Processes with Flow
Safe handling of hazardous reagents and accessing optimal material CQA’s pose significant challenges. We have risen to these challenges by pioneering the practical use of flow and continuous processing for chemistry and crystallization development.
1000s of Virtual Mixing Experiments
Companies are under increasing pressure to answer their CMC questions faster. We use computational fluid dynamics to simulate mixing environments for upstream and downstream bioprocesses. This allows us to run 1000s of virtual experiments informing our scale-up strategy, slashing development time and allowing us to hit product requirements right first time.
Screening for Solvents, Digitally
Selection of the optimal solvent in which to perform reactions and crystallizations plays a critically important role in process development. We use advanced thermodynamic and quantum chemistry models to select solvent systems for reactions and crystallizations without having to resort to brute force screening methods. This way we select better solvents in less time, accelerating development.
Analytical Precision and Speed
As therapeutics become increasingly complex, so do the analytical methodologies required to analyze them. We have built our analytical capabilities from the ground up and found new ways to serve our processes development teams with speed and accuracy. Our analytical technology infrastructure is second-to-none and is capable of characterizing the world’s most advanced medicines.
Automation at Scale
Manual experimentation can be slow and prone to consistency and reproducibility issues. We equipped our AMBR 250 with a state-of-the-art suite of process analytics tools and coupled it with a team of statisticians and modelers that can crunch the data. We can run 100s of ultra-precise bioprocesses in a short space of time, finding the most important process parameters quickly.
Expedited Tech Transfer
We built our state-of-the-art non-GMP biologics pilot plant so that the scientists involved in developing the process can also scale and optimize it without unnecessary constraints and costs. This means that it can subsequently be transferred right-first time directly into a GMP facility of choice.