The Process Development Blog

We’re delighted to announce that APC has received Deloitte's 'Ireland's Best Managed Company Award' at a gala in Dublin on September 14, 2023. This award is given based on a company's overall success, including its company culture, management strength, capacity for innovation, strategic initiatives, sustainability, and financial performance.

In this webinar, we will explore the development of a 2nd generation downstream process for a complex biotherapeutic and discuss strategies to significantly reduce the number of unit operations, increase yields, reduce costs, and accelerate time-to-market while meeting CQA specifications.

Data generated throughout a medicine’s CMC development journey is often fragmented, siloed and lacks context - causing regulatory bottlenecks, manufacturing delays, and ongoing quality issues. During this discussion, panelists explore the criticality of data visibility in the CMC journey and learn practical strategies to improve data management, contextualization, and integrity.

APC and VLE are set to exhibit at BOS Basel, July 4-5. Visit us at booth 42!

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.

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.

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.

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.

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.

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.