Drug Development

Articles

The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.

GE Healthcare Equips China Cell Therapy Manufacturing Plant with FlexFactory

Bosch Packaging Technology will introduce its newest R&D device for continuous oral solid dosage production at Achema 2018.

Bosch Presents R&D Device for Continuous Oral Solid Dosage Production at Achema 2018

Ingenza, in partnership with the University of Dundee and Drochaid Research Services, will work on a project to recycle CO2 emissions from bioprocessing plants to serve as feedstock and energy inputs.

Ingenza in Collaboration to Recycle CO2 from Bioprocessing Plants

GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) will support scale-up efforts by DiscGenics for a new cell therapy intended to treat back pain.

GE and CCRM Partner with DiscGenics on New Cell Therapy

Aaron Strand, PE is a senior research engineer with SPX FLOW, aaron.strand@spxflow.com

Nicolle Courtemanche is a senior application engineer with SPX FLOW, nicolle.courtemanche@spxflow.com

Aerobic bioprocesses are highly dependent upon the oxygen transfer rate (OTR) from sparged to dissolved gas. The relatively low solubility of oxygen, however, makes the choice of mixer impeller configuration a critical design factor for the bioreactor vessel. This article describes a series of experiments and computational fluid dynamics (CFD) simulations to detail the effect of mixer configuration on the efficiency and effectiveness of a bioreactor vessel with respect to blend time and mass transfer.

Impact of Agitator Design on Bioreactor Performance

Lennart Eriksson, PhD, is senior lecturer and data scientist at Sartorius Stedim Data Analytics.

Chris McCready is lead data scientist at Sartorius Stedim Data Analytics

Advanced data analytics tools are used by industry to find the golden nuggets in historical data, to aid in process development, to fine-tune production, and to achieve long-term improvements in product quality and throughput.

Characterizing a Bioprocess with Advanced Data Analytics

Russell E. Madsen is the former senior vice-president of science and technology at PDA, and is a current member of Pharmaceutical Technology's editorial advisory board.

James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, akainckc@aol.com.

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

Environmental monitoring, which operates below the limit of detection, is little more than a rote exercise that provides limited real value. So why does it figure so prominently in current regulatory requirements for aseptic manufacturing?

Lies That Environmental Monitoring Systems Tell

Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies.

Understanding Validation and Technical Transfer

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.

FDA Moves to Overhaul New Drug Review Process

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Determining the right process conditions for a freeze-drying cycle requires an understanding of the effect of each step on the drug product.

Process and Scaling