Authors


Chris McCready

Latest:

Characterizing a Bioprocess with Advanced Data Analytics

Modeling at various stages of the data analytics continuum aids scale comparison of a bioreactor.


Linda Joy

Latest:

Good Quality Agreements Support Compliance with CGMP

Drug manufacturers can improve use of quality agreements in contract manufacturing.


Jessica Ritsick

Latest:

Good Quality Agreements Support Compliance with CGMP

Drug manufacturers can improve use of quality agreements in contract manufacturing.


Paula Katz

Latest:

Good Quality Agreements Support Compliance with CGMP

Drug manufacturers can improve use of quality agreements in contract manufacturing.


Tamara Ely

Latest:

Good Quality Agreements Support Compliance with CGMP

Drug manufacturers can improve use of quality agreements in contract manufacturing.





John Zehmer

Latest:

Application of Quality by Design to Viral Safety

A quality-by-design approach that defines potential viral contaminants of source materials can be used to achieve viral clearance.


Kathryn Martin Remington

Latest:

Application of Quality by Design to Viral Safety

A quality-by-design approach that defines potential viral contaminants of source materials can be used to achieve viral clearance.


Philip Hoersch

Latest:

Quality Oversight During Sterile Filling Operations

The author reviews operative options for the implementation of a quality oversight and how companies can benefit from this function from a regulatory perspective.



Cygnus Technologies

Latest:

AAE Empowers HCP Identification by MS

AAE and MS integration enables comprehensive HCP analysis, facilitates process development, and helps determine whether your HCP ELISA is fit for purpose of process monitoring and product lot release.





Paul DeRose

Latest:

NIST Spectroscopic Measurement Standards

The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance measurements for use with the new generation of microvolume spectrophotometers and short-pathlength cuvettes.


Kenneth D. Cole

Latest:

NIST Spectroscopic Measurement Standards

The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance measurements for use with the new generation of microvolume spectrophotometers and short-pathlength cuvettes.


Aaron Urbas

Latest:

NIST Spectroscopic Measurement Standards

The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance measurements for use with the new generation of microvolume spectrophotometers and short-pathlength cuvettes.


Steve Choquette

Latest:

NIST Spectroscopic Measurement Standards

The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance measurements for use with the new generation of microvolume spectrophotometers and short-pathlength cuvettes.


Evelyn Solis

Latest:

NIST Spectroscopic Measurement Standards

The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance measurements for use with the new generation of microvolume spectrophotometers and short-pathlength cuvettes.


Erica V. Stein

Latest:

NIST Spectroscopic Measurement Standards

The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance measurements for use with the new generation of microvolume spectrophotometers and short-pathlength cuvettes.


John Schiel

Latest:

NIST Spectroscopic Measurement Standards

The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance measurements for use with the new generation of microvolume spectrophotometers and short-pathlength cuvettes.


Brian Lang

Latest:

NIST Spectroscopic Measurement Standards

The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance measurements for use with the new generation of microvolume spectrophotometers and short-pathlength cuvettes.


Hua-Jun He

Latest:

NIST Spectroscopic Measurement Standards

The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance measurements for use with the new generation of microvolume spectrophotometers and short-pathlength cuvettes.


Jean-Marc Cappia

Latest:

An Integrated Approach to Shipping Liquid in Single-Use Systems

Increased use of single-use systems has led to a need to redefine safe, stable and integral systems for shipping biopharmaceuticals around the world. This article provides qualification data under international ASTM D4169 norms.


Ewelina Flamm

Latest:

Supplier-Change Management for Drug-Product Manufacturers

An effective supplier-initiated change management process is discussed.



Jill E. Sackman, PhD

Latest:

Market Access Outlook for Australia

The Australian pharmaceutical market offers opportunities for manufacturers despite challenges.


Susanne Keitel

Latest:

Finished Product Monographs in the European Pharmacopoeia

The European Pharmacopoeia Commission re-evaluates its policy on the development of monographs for finished drug products.

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