Authors



David Semin

Latest:

Evaluating Progress in Analytical Quality by Design

The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.


Gunnar Kahlmeter

Latest:

What is Antibiotic Resistance?

The author looks at EUCAST’s role in tackling the spread of antimicrobial resistance, by creating definitions for a global consensus.



Isochem

Latest:

Vitamin E TPGS for Drug Delivery Innovation

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Russell Madsen

Latest:

Unknown and Unknowable

Quality cannot be verified through testing, especially at the limit of detection, and no test method can confirm the absence of a microbe or particle.


Sidney Backstrom

Latest:

The Quest for Cleanroom Flexibility

Contextualizing what type of flexibility is needed is paramount when considering cleanroom design.



Divya Tewari

Latest:

Customizing HPMC to Minimize Drug Variability

The authors evaluated the performance and robustness of controlled-release tablets made with HPMC blends of unimodal and bimodal molecular weight distribution.


Thomas Durig

Latest:

Customizing HPMC to Minimize Drug Variability

The authors evaluated the performance and robustness of controlled-release tablets made with HPMC blends of unimodal and bimodal molecular weight distribution.


John Randall

Latest:

Optimizing Accuracy in Pinch Valves for Sterile Injectables

Preheating pinch valves prevents drift in the volume of liquid dispensed.


Denis Keyes

Latest:

Optimizing Accuracy in Pinch Valves for Sterile Injectables

Preheating pinch valves prevents drift in the volume of liquid dispensed.


Chris McNulty

Latest:

Cleaning Bioreactors and Fermenters with CIP Systems

Early planning for the integration of clean-in-place systems for equipment cleaning is key.



Michael Schmitz

Latest:

Dealing with Pharmaceutical Supply-Chain Complexities

Planning ahead is key to enabling a continuous and secure supply chain that adapts to changes in market demand.


David Deere

Latest:

Biosimilars and Healthcare Policy: What China Can Learn from the EU and US

While food, shelter, and clothing are the primal essentials for life, hope-as embodied by modern medicine-has now become part of that human expectation.


Frank Generotzky

Latest:

Designing Flexible Aseptic Containment Systems

The design of Baxter BioPharma Solutions’ aseptic filling lines provides a case study in customizing containment systems for multi-product lines


Martin Tuckermann

Latest:

Designing Flexible Aseptic Containment Systems

The design of Baxter BioPharma Solutions’ aseptic filling lines provides a case study in customizing containment systems for multi-product lines


Sam de Costa

Latest:

Breaking the Cold Chain for Vaccines

Aseptic spray drying offers a technology alternative to manufacture thermally stable vaccines.


Ann Pearson

Latest:

Evaluating Practical Uses of Molecular Isotopic Engineering

The authors' directed isotopic synthesis is one example of how molecular isotopic engineering can be used to predetermine the discrete isotopic ranges of biopharmaceutical products.


Anthony Sabatelli

Latest:

Evaluating Practical Uses of Molecular Isotopic Engineering

The authors' directed isotopic synthesis is one example of how molecular isotopic engineering can be used to predetermine the discrete isotopic ranges of biopharmaceutical products.


Peter Farina

Latest:

Evaluating Practical Uses of Molecular Isotopic Engineering

The authors' directed isotopic synthesis is one example of how molecular isotopic engineering can be used to predetermine the discrete isotopic ranges of biopharmaceutical products.


Peter Mezes

Latest:

Evaluating Practical Uses of Molecular Isotopic Engineering

The authors' directed isotopic synthesis is one example of how molecular isotopic engineering can be used to predetermine the discrete isotopic ranges of biopharmaceutical products.



Mark A. Snyder

Latest:

Surface Neutralization System

A new, robust method for protein elution from ceramic hydroxyapatite.