BioPharm International
October 02, 2020
Cover Story
33
10
Automation, digitalization, and supply-chain strategies help mitigate vulnerabilities in both autologous and allogeneic cell therapy manufacturing.
October 02, 2020
Development
33
10
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.
October 02, 2020
Upstream Processing
33
10
Bioreactor technology advances can offer seamless manufacturing scale-up and can reduce the timeline and cost of biologics production.
October 01, 2020
Downstream Processing
33
10
A balance must be achieved between debris and impurity removal and maximizing product quality and yield.
October 01, 2020
Manufacturing
33
10
Fill/finish inspection for vaccine vials and syringes must remain GMP-compliant while aiming for fast, efficient methods.
October 01, 2020
Manufacturing
33
10
Glycoengineering is growing in importance as a technique to improve antibody therapeutic efficacy, safety, and product quality.
October 01, 2020
Quality/Regulations
33
10
A data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software.
October 01, 2020
Analytics
33
10
This article discusses standardized analytical method-transfer kits that have been developed to streamline method transfer and site certification at Eli Lilly. Use of these kits has been proven to improve overall efficiency and to reduce cost and time requirements for method transfer.
October 01, 2020
Operations
33
10
Best practices to consider when transitioning from research-grade to GMP-grade materials.
October 01, 2020
Regulatory Beat
33
10
Drug shortages and supply chain challenges bolster FDA efforts to promote modern manufacturing.
October 01, 2020
From the Editor
33
10
Misleading messages contribute to eroding trust in public health agencies