Authors









Daniela Lega

Latest:

Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line

Use of a subspace model is a viable method to characterize process space variables and optimize process performance.


Colin Jaques

Latest:

Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line

Use of a subspace model is a viable method to characterize process space variables and optimize process performance.


Alfred Weber

Latest:

Variable Pathlength Fiber-Optic Spectrophotometry for Protein Determination in Immunoglobulin Concentrates

The authors evaluate the SoloVPE technique as a replacement for nitrogen-based protein determination.


Heinz Anderle

Latest:

Variable Pathlength Fiber-Optic Spectrophotometry for Protein Determination in Immunoglobulin Concentrates

The authors evaluate the SoloVPE technique as a replacement for nitrogen-based protein determination.



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.

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