Cell Line Selection
Our cell line screening strategies enable faster identification and selection of the final clonal cell line acceleration of analytical and process development, shaving months of CMC timelines.
Our cell line screening strategies enable faster identification and selection of the final clonal cell line acceleration of analytical and process development, shaving months of CMC timelines.
We combine modeling with smart experiments to choose off-the-shelf media that cells love, avoiding costly licensing arrangement, reducing the risk of adventitious agents, and targeting stringent regulatory and quality requirements.
We take mAbs, cell and gene therapies, vaccines, viruses and microbial based systems from proof of concept to launch in record time across glassware, bioreactors and wavebags.
We have deep experience working with adherent cell lines and can develop game-changing microcarrier-based processes that drive productivity and offer better scale-up options compared to other options.
Our scientists collect information on up to 30 different metabolites, every 4 to 6 seconds, for every bioprocess we run and then combine this information with a model predictive control architecture that enables the bioreactor to optimize itself.
We believe that process understanding is the raw material from which medicines are made and our upstream process development team leverage the latest process and analytical tools to gather key information that informs best-in-class process design.
Our team of dedicated downstream experts can design, build and optimize filtration, chromatography and separations systems in record time, and take them into manufacturing seamlessly.
We evaluate every upstream process individually and design a separations system that makes sense, leveraging chromatography, TFF and hollow fiber TFF to deliver the highest product yields possible.
APC scientists have developed a next generation platform that combines CFD simulations with lab scale-down models that can troubleshoot problematic separation steps that are slowing the pace of development or putting supply at risk.
We built an advanced chromatography modeling platform that can outperform standalone DoE studies and makes the DoEs we do run smaller and smarter, speeding development and getting to the right chromatography answers faster.
We take processes from flatware to bioreactors and wave bags in less time than anyone else and our focus on process understanding leads to seemless tech transfers and right first time manufacturing introductions.
We use PAT tools such as Raman and mid-IR to understand the kinetic landscape of upstream processes, enabling us to design feeding and mixing regimes that outperform alternatives and scale-up perfectly.
Using CFD we run 1000s of virtual experiments before lab work commences, helping build better lab models and designing bioreactors faster than was previously thought possible.
By aggregating and analyzing 100s of datasets collected across development and manufacturing our teams take documentations reviews to a new level, solving manufacturing problems instantly and shortening development time by thoroughly leveraging existing data.
Our tech transfer strategy us powered by our powerful digital platform, iACHIEVE, which captures all process development information and enables it to be shared easily with everyone in your manufacturing network.
Our people go where the medicines requires, visiting your manufacturing sites to support scale up and tech transfer activities through short term assignments.
We use kinetic, statistical, and state-of-the-art computational fluid dynamic process modelling platforms to build process understanding, define scale-up strategies and get tech transfer right the first time.
With the ability to run bioprocesses in single use systems at up to 250L scales we can test process performance before transfer to GMP manufacturing suites.
Our analytical team is exclusively focused on process development, meaning your analytical work will never go to the back of a GMP manufacturing queue and our people know how to solve real process development challenges.
We tailor method development, validation and transfer to the specific needs of each client and molecule collaborating closely with scientists across upstream, downstream and manufacturing sciences, to get the best methods running quickly.
Our world-class analytical infrastructures enables us to run 97% of the methods we need for upstream and downstream process development in-house, with key analytical methods available in the same lab as our bioreactors.
Instead of applying a one-size fits all approach to characterizing large molecules we collaborate closely with clients to use methods that go fast when needed, and deep when required.
Our goal is to make working with us effortless, and our dedicated team of project managers make this happen, asking the right questions, keeping the end goal in mind, and constantly driving us and you to deliver.
Led by a dedicated and brilliant team – 90% of us are PhDs with years of manufacturing experience – your medicine is in the best hands from project scoping to CMO hand-off and all points in between.
We learn and grow together with our clients, deepening our skills, finding new breakthroughs and thriving in a process development environment where every day is different.
As perpetual innovators and disruptors in the process development space, we're constantly cultivating new talent and enhancing our capabilities.