The Process Development Blog
Cutting edge process development insights and news from APC.
June 29 2023: Online Panel Discussion: Data Visibility & Ownership when Working with External Partners
During this panel discussion, attendees will gain a deeper understanding of the criticality of data visibility in the CMC journey and learn practical strategies to improve data management, contextualization, and integrity.
Is a 10% yield improvement possible within your regulatory filing?
Using data-rich experimentation and mixing models, which leverage CFD, a right-first scale up of the new process was achieved within the yield improvements translating directly back to the plant.
Accelerated Upstream Process Optimization Using a QbD Approach
APC applied its BioACHIEVE® process development technology platform to improve the process performance of a Chinese Hamster Ovary (CHO) mammalian cell bioprocess operated in a 2.5 L bench-top bioreactor, by optimising the bioreactor feed profile by moving from a traditional bolus to a PAT-enabled continuous feeding strategy in order to prevent nutrient depletion and deliver a stable macroenvironment for the cells.
How to access differentiated API particle populations through continuous technologies
For the synthesis and crystallization of APIs, the application of multistage Mixed Suspension Mixed Product Removal Crystallizers (MSMPRCs) can be beneficial in accessing particles of different size and morphology thus overcoming common problems encountered in batch production.
[WEBINAR] Tech Transfer without the Jet Lag!
Tech transfer is fraught with challenges, and it's crucial to have a solid understanding of the process, as well as, modern strategies for success. Our experts review challenges, discuss proven strategies for successful tech transfer, and highlight how VLE Therapeutics takes a unique approach to tech transfer through a focus on digitalization, process optimization, and risk management.
[WEBINAR] Development strategies to keep pace with increasing stereochemical complexity of drug candidates
Faster development despite rising stereochemical complexity! In this webinar, Brendan Roche, PhD reviews engineering strategies which can be applied to key unit operations (e.g. crystallization, isolation etc.) of enantiomers and diastereomers of varying stereochemical complexity.
The importance of choosing the correct chromatography resin
In this case study, the final chromatography step in the purification of a monoclonal antibody (mAb) was proving problematic - with significant yield loss (up to 50%) observed across the polishing step. Learn how experts ensured a robust, commercially viable purification step and ultimately accelerated the development of the medicine.
March 9 2023: Faster development despite rising stereochemical complexity!
Brendan Roche PhD will present 'Development strategies to keep pace with increasing stereochemical complexity of drug candidates', reviewing how experts leverage the power of PAT, modelling, and other cutting-edge techniques which can be applied to key unit operations (e.g. crystallization, isolation etc.) of enantiomers and diastereomers of varying stereochemical complexity.
Dynamic Light Scattering: A Tool to Accelerate Oncolytic Vaccine Development
This case study highlights the significance of particle size measurement utilizing dynamic light scattering (DLS) in the development of vaccines based on the MVA virus.