Authors


Stephen M. Perry

Latest:

Elasticity – A Modern Paradigm for a High Performance Workforce

Top C-suite leaders are already tuning their long-range planning, hiring practices, and business systems for elasticity. Are you ready?


Dijana Hadziselimovic

Latest:

Considerations for Cleaning Lipid Nanoparticles

This article explores the concerns with cleaning pharmaceutical products utilizing LNP delivery vehicles and provides a general cleaning recommendation based on laboratory and field testing.


Marc Hogreve

Latest:

Point-of-Use Leak Testing of Single-Use Bag Assemblies

The authors describe the development and validation of a highly sensitive point-of-use pressure decay test.


Siegfried Schmitt

Latest:

Real-World Evidence as Part of Pharmacovigilance

Siegfried Schmitt, PhD, vice-president, Technical at Parexel, answers questions on the use and benefits of real-world evidence for small-molecule and large-molecule drug development.


Natalia Markova

Latest:

Shining a Light on Lipid Nanoparticle Characterization

Using an orthogonal approach to lipid nanoparticle analysis can increase the odds of project success.


Christian Fortunel

Latest:

The Transition to Electronic Records

A four-stage process to successfully make the switch from paper to electronic batch records is presented.


Ashleigh Wake

Latest:

Characterization and Impurity Analysis of Oligonucleotide Therapeutics

Analytical technologies play a key role in the characterization and quantitation of oligonucleotide therapeutics.


Niels Væver Hartvig

Latest:

Understanding Internal Release Limits

Internal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.


Liselotte Kamper

Latest:

A Statistical Decision System for Out-of-Trend Evaluation

The authors present a set of statistical decision rules based on linear regression models that can be implemented in an automated trend system to assist stability studies.


SCHOTT AG

Latest:

SCHOTT Vials DC Demonstrate Resistance against Delamination in New Screening Study

A new series of studies has demonstrated the effectiveness of SCHOTT Vials Delamination Controlled (DC), which can replace existing packaging solutions without re-registration and offers higher product security.


Catherine Shaffer

Latest:

Ensuring the Biological Integrity of Raw Materials

A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.


Johanna Berberich

Latest:

The GMP/GDP Inspections Landscape—Part II: Considerations and Opportunities

The authors look at challenges and considerations to continuously improve inspection efficiency.


Peter Kitz

Latest:

The GMP/GDP Inspections Landscape—Part II: Considerations and Opportunities

The authors look at challenges and considerations to continuously improve inspection efficiency.


Véronique Davoust

Latest:

The GMP/GDP Inspections Landscape—Part II: Considerations and Opportunities

The authors look at challenges and considerations to continuously improve inspection efficiency.


Andreas Pfenninger

Latest:

The GMP/GDP Inspections Landscape—Part II: Considerations and Opportunities

The authors look at challenges and considerations to continuously improve inspection efficiency.


David J. Skanchy

Latest:

Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs

The authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions.


Jizhou Wang

Latest:

Appendix: Common Deficiencies Related to Solution NMR in the Type-II DMFs

Appendix to Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs, Part I: Solution Nuclear Magnetic Resonance Spectroscopy


Huyi Zhang

Latest:

Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs

The authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions.


Neeru Takiar

Latest:

Appendix: Common Deficiencies Related to Solution NMR in the Type-II DMFs

Appendix to Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs, Part I: Solution Nuclear Magnetic Resonance Spectroscopy


Jana Spes

Latest:

Continuous Manufacturing: A Generic Industry Perspective

The pharmaceutical industry is making efforts by internally assessing, developing, and implementing semi-continuous manufacturing processes to improve manufacturing efficiencies.


Brian Keesee

Latest:

Careful, Early Cold-Chain Planning is Crucial for New Biologics

Cold-chain requirements and the tight logistical windows needed for cell and gene therapies demand a focus on early communication and risk mitigation.


Staffan Widengren

Latest:

Serialization: The Final Countdown

Many pharmaceutical manufacturers were late in involving contract partners in serialization efforts. Are you ready, and are you working with the right partner?


Haris Kamal

Latest:

Serialization Preparation Prompts Data and Business Questions

As the date for implementation of the Drug Supply Chain Security Act approaches, bio/pharma companies and contractors should focus on key areas.


Charlotte Hicks

Latest:

Monitoring Supply Chain Risk on a Limited Budget

Monitoring supply-chain risk involves more than running a credit check on potential suppliers. It can, however, done without external expense.


Silvia Rocchi

Latest:

Evaluating E&L Studies for Single-Use Systems

Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.


Gabriella Angiuoni

Latest:

Evaluating E&L Studies for Single-Use Systems

Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.


Irene Cecchini

Latest:

Evaluating E&L Studies for Single-Use Systems

Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.


Daniele Mastroianni

Latest:

Evaluating E&L Studies for Single-Use Systems

Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.


Philip Lienbacher

Latest:

Collaborating for Efficiency and Safety in Raw Material Inspection

By working together and taking a QA-based approach, manufacturers and suppliers can reduce raw material testing requirements.


Manfred Karner

Latest:

Collaborating for Efficiency and Safety in Raw Material Inspection

By working together and taking a QA-based approach, manufacturers and suppliers can reduce raw material testing requirements.

© 2025 MJH Life Sciences

All rights reserved.