Authors



Bob McDowall

Latest:

Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?

Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices.






Rebecca Duke

Latest:

N-Glycan Composition Profiling for Quality Testing of Biotherapeutics

Advances in glycan analysis are enhancing biologics development and quality control processes.


Peter Soelkner

Latest:

Empire State Drug Development

An architectural wonder teaches the biopharmaceutical industry a valuable lesson in project management.




Dinesh Goudar

Latest:

Precipitation as an Alternative to Chromatography in the Insulin Manufacturing Process

The authors explore the use of precipitation using polyvinyl sulfonic acid and zinc chloride in place of capture chromatography to reduce the cost of goods in the insulin manufacturing process.


Sai Srikar Kandukuri

Latest:

Precipitation as an Alternative to Chromatography in the Insulin Manufacturing Process

The authors explore the use of precipitation using polyvinyl sulfonic acid and zinc chloride in place of capture chromatography to reduce the cost of goods in the insulin manufacturing process.


Madhavan Buddha

Latest:

Kinetic and Structural Differentiation of Trypsin from Different Origins

This study aims at understanding the differences between porcine and bovine trypsin from both pancreatic and recombinant origins.


Sinash Siddik

Latest:

Precipitation as an Alternative to Chromatography in the Insulin Manufacturing Process

The authors explore the use of precipitation using polyvinyl sulfonic acid and zinc chloride in place of capture chromatography to reduce the cost of goods in the insulin manufacturing process.


Shabandri Qais

Latest:

Precipitation as an Alternative to Chromatography in the Insulin Manufacturing Process

The authors explore the use of precipitation using polyvinyl sulfonic acid and zinc chloride in place of capture chromatography to reduce the cost of goods in the insulin manufacturing process.


Shailabh Rauniyar

Latest:

Precipitation as an Alternative to Chromatography in the Insulin Manufacturing Process

The authors explore the use of precipitation using polyvinyl sulfonic acid and zinc chloride in place of capture chromatography to reduce the cost of goods in the insulin manufacturing process.


Partha Hazra

Latest:

Kinetic and Structural Differentiation of Trypsin from Different Origins

This study aims at understanding the differences between porcine and bovine trypsin from both pancreatic and recombinant origins.


Siddharth Mahajan

Latest:

Precipitation as an Alternative to Chromatography in the Insulin Manufacturing Process

The authors explore the use of precipitation using polyvinyl sulfonic acid and zinc chloride in place of capture chromatography to reduce the cost of goods in the insulin manufacturing process.


Keqiang Shen

Latest:

Implementing Single-Use Technology in Tangential Flow Filtration Systems in Clinical Manufacturing

A case study evaluates the performance, control of operations, productivity, and cost savings of a single-use system.



Rajeev J. Ram

Latest:

Tools for Continuous Bioprocess Development

In semiconductor manufacturing, for example, a thorough understanding of process variation allows companies to manufacture circuits with billions of transistors at high yields. These variations are translated into a set of design rules, which help ensure that designs will be manufactured successfully and meet safety and other regulatory requirements.


Mohd Helmi Sani

Latest:

Mixing Time as a Criterion for Scale Translation of Cell-Culture Processes

The authors conclude that miniature bioreactors can adequately predict the cell culture kinetics in scaled-up reactors using equal mixing times.


Frank Baganz

Latest:

Mixing Time as a Criterion for Scale Translation of Cell-Culture Processes

The authors conclude that miniature bioreactors can adequately predict the cell culture kinetics in scaled-up reactors using equal mixing times.


Jyoti Batra

Latest:

Antibody Production in Microbial Hosts

The authors review the status of expression of antibodies in microbial hosts and present the recent advances in the production of aglycosylated antibodies in bacteria.


Alison Armstrong, PhD

Latest:

Advances in Assay Technologies for CAR T-Cell Therapies

Rapid methods to test CAR-T therapies for potential contamination are on the horizon.


Jan Weegar

Latest:

The Use of the ATF System to Culture Chinese Hamster Ovary Cells in a Concentrated Fed-Batch System

Cell concentrations and resulting protein concentrations are higher in a concentrated fed-batch process than in a standard fed-batch culture system.


Kate Hammeke

Latest:

Contract Services Spending: Who's Spending What, and Where?

A survey provides insight into drug companies' plans for spending on outsourced services. This article contains bonus online material.




Duarte Miguel F. Prazeres

Latest:

Use of an E. coli pgi Knockout Strain as a Plasmid Producer

The authors describe the impact of the knocking of the pgi gene of the wild type MG1655 strain on the growth kinetics of plasmid-free and plasmid-bearing cells.

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