Monoclonal Antibodies and Continuous Processing: A Case Study Examination

Monoclonal antibody-based therapeutics are well established in the pipelines of biopharmaceutical organizations and have decades of development ahead. However, not all of them have disclosed or confirmed amino acid sequences. Ultra-high-performance liquid chromatography mass spectrometry provides a powerful tool to obtain the sequence information to the residue level. Historically, the process has needed expert users and therefore was extremely low throughput and is often outsourced.

Mixed Reality (MR) also known as “hybrid reality” and “extended reality,” has the potential to change just about every industry, healthcare being no exception. A combination of Virtual Reality (VR), Augmented Reality (AR), and Artificial Intelligence (AI); MR is emerging as a tech to create experiences that blend the real-life environment with digital elements.

There is more to Biopreservation than storage on ice or freezing at a rate of -1°C/min. To comprehend the rationale behind Biopreservation Best Practices, a basic understanding of cellular response to cold and freezing is essential. This presentation will identify the critical process parameters (CPPs) of Cold Chain, such as freezing and thawing rates, storage and post-thaw stability, and container type, among others, and will discuss the impact of these CPPs on critical quality attributes (CQAs) such as viability, yield, proliferation rate, and return to function.

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) supports a large network of National Centers for Biomedical Imaging and Bioengineering (NCBIB) through the P41 grant mechanism.