December 02, 2021
Cover Story
34
12
Timing is everything, and it might be ideal for acceleration of real-time monitoring solutions.
December 02, 2021
Development
34
12
Autologous tumor cells engineered for immune system stimulation can target unique metabolic, genomic, and phenotypic characteristics of cancer cells.
December 02, 2021
Manufacturing
34
12
Isolators move into smaller-volume processes, including cell and gene therapy manufacturing.
December 02, 2021
Upstream Processing
34
12
Defining expectations, such as GMPs, is paramount for sourcing the right biopharmaceutical raw materials.
December 02, 2021
Downstream Processing
34
12
Confounding signals pose challenges to analytical methods necessary for managing residual impurity removal in biotherapeutic manufacturing.
December 01, 2021
Quality
34
12
While supply chain disruptions have resulted in many alterations to workplace practices, they have also presented an opportunity to get ahead of changes to the EU’s upcoming revision of Annex 1.
December 01, 2021
Analytics
34
12
Glycosylation monitoring has been heavily dependent on manual processes, but the automation of sample preparation streamlines the overall workflow.
December 01, 2021
Outsourcing
34
12
Partnerships formed during the COVID-19 pandemic have provided a platform for change in assay development and transfers that should continue in the future.
December 01, 2021
BioBusiness
34
12
COVID-19 is refocusing calls for new tools and urgent therapeutic responses.
December 01, 2021
Regulatory Beat
34
12
The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.
December 01, 2021
From the Editor
34
12
We have broken rules, invented new ones, and engineered stronger institutions and supply chains that will serve us better going forward.
December 01, 2021
Ask The Expert
34
12
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about the difference between the roles of quality assurance and quality control.