The biopharmaceutical industry characterizes and quantifies aggregation of protein therapeutics using multiple analytical techniques to cross-validate results. Here, we demonstrate the use of electrospray-differential mobility analysis (ES-DMA), a gas-phase and atmospheric pressure ion-mobility method for characterizing protein aggregates. Two immunoglobulin Gs are systematically heat treated t...

Biopharmaceutical and pharmaceutical manufacturing are strongly influenced by the process analytical technology initiative (PAT) quality design (QbD) methodologies, which designed to enhance understanding of more integrated processes [...]

Considering the performance decay of the chromatography resins in the downstream purification of biopharmaceutical manufacturing, the maintenance decisions should be made at appropriate times to achieve a good performance of the whole manufacturing process. In this paper, on the basis of the literature work on production planning, a mixed integer linear programming optimization model is develop...

Characterization of biopharmaceutical proteins and assessment and understanding of the critical quality attributes (CQAs) is a significant part of biopharmaceutical product development and is routinely performed in vitro. In contrast, systematic analysis of the quality attributes in vivo is not as widespread, although metabolism and clearance of multiple variants of therapeutic proteins adminis...

www.pharmtech.com evelopment and validation of bioanalytical methods for pharmaceutical product analysis are common rate-limiting steps in biopharmaceutical product development. A rational, strategic approach to developing robust, automated, validated bioanalytical methods can reduce slowdowns and bottlenecks in drug development and contribute to synergistic, consistent, longterm performance. T...

High-performance computing (HPC) has become a state strategic technology in a number of countries. One hypothesis is that HPC can accelerate biopharmaceutical innovation. Our experimental data demonstrate that HPC can significantly accelerate biopharmaceutical innovation by employing molecular dynamics-based virtual screening (MDVS). Without using HPC, MDVS for a 10K compound library with tens ...

We explore how an incumbent firm’s internal knowledge and organization structure influences its strategic alliance formation. We propose that the firm’s knowledge breadth and the centrality of its R&D organization structure positively influence its absorptive capacity, and consequently, its propensity to form strategic alliances. We also argue that the centrality of the R&D organization structu...