Authors


Gayatri C. Patel

Latest:

Formulation of Modified Liquid-Solid Compact for Dissolution Enhancement of Raloxifene Hydrochloride

The purpose of this research was to formulate modified liquisolid compacts (MLSC) of RLX for improved dissolution in immediate-release tablet formulations.



James Agalloco

Latest:

Complications in Process Simulation Execution

Regulators have exaggerated expectations for simulated media fills.


Nelson Laboratories

Latest:

Developing Contamination Control Strategy

Webinar Date/Time: Wed, Jul 19, 2023 1:00 PM EDT


Florence Buscke, Pharma Insights Contributor, Sr. Global Product Manager, Schott

Latest:

Smoothly Through the Production Process

SCHOTT has run a series of line tests to prove the efficacy and efficiency of its modular EVERIC product concepts against vial breakage. The results show a great increase in glass strength. | Sponsored Content



Shimadzu

Latest:

LabSolutions Insight Biologics

LabSolutions Insight Biologics, a complete workflow from data acquisition to analysis and reporting! Your dedicated workspace for oligonucleotide characterisation.


Aaron Sato

Latest:

Antibody Development Made Easier with Synthetic Biology

Synthetic biology can help researchers circumvent the challenges of traditional methods of antibody generation.


Tim Roach

Latest:

Best Practices for Design and Operation of Multiproduct Manufacturing Facilities

Careful design, planning, and record keeping are needed for cleaning and changeover in multiproduct pharmaceutical facilities.


Bill Jarvis

Latest:

Designing Commercial-Scale Oligonucleotide Synthesis

Consider current large-scale practices for oligonucleotide synthesis as a basis for improving commercial-scale platform strategies.


Tony Pavone

Latest:

Designing Commercial-Scale Oligonucleotide Synthesis

Consider current large-scale practices for oligonucleotide synthesis as a basis for improving commercial-scale platform strategies.


Isaiah Cedillo

Latest:

Designing Commercial-Scale Oligonucleotide Synthesis

Consider current large-scale practices for oligonucleotide synthesis as a basis for improving commercial-scale platform strategies.


Kai Vogt

Latest:

Digitalization: A CDMO’s Perspective

CDMOs must consider challenges associated with the complexity of contract pharmaceutical manufacturing when approaching digitalization projects.


Aaron O. Bailey

Latest:

How Advanced Mass Spectrometry Technologies and Workflows are Delivering Comprehensive Protein Characterization

Complex protein structures pose analytical challenges that can be addressed by advanced mass spectrometry technologies and workflows, which can be used to comprehensively characterize them.


Donald A. Johnson, PhD, RAC

Latest:

Quantitative Rupture Testing of Soft Gelatin Capsules: Understanding Aberrant Results

This paper discusses what causes cross-linking, how cross-linking is addressed with addition of enzymes, and consideration for occasional high results that can be obtained during release testing.


Jan Paul Zonnenberg

Latest:

Building a Business Case for Quality Management Transformation

Can the pharmaceutical industry embrace the goals of Quality 4.0?


Alberto Santagostino

Latest:

Using the ‘Cubic Effect’ to Drive Cell and Gene Therapy Commercialization

Contract partners must help innovators, especially smaller and virtual companies, consider manufacturability as early as possible in development. This requires focusing on technical and operational performance, as well as cost.


Steve Scheuring

Latest:

Establishing and Maintaining an Effective Gas Evaluation and Management Program

The author examines the challenges that arise in ordering, storing, and using gas supplies for the pharmaceutical laboratory, and suggests solutions to these difficulties.


Master Control

Latest:

Using AI for CAPA and Root-Cause Investigations

*Thursday, May 6, 2021 at 2pm EDT | 1pm CDT | 11am PDT* Learn how artificial intelligence can be used to investigate corrective and preventive actions, pinpoint the root cause of the most common complaints, tell if training is effective, and identify the combination of materials and workers to increase production. *On Demand Until May 6, 2022*


Shimadzu Europa

Latest:

The MALDImini-1: Entering the Digital Age in MS

The first-of-its-kind MALDImini-1 digital ion trap mass spectrometer targets comprehensive structural analyses applications. It is the only device capable of MALDI-MSn on the compact footprint of an A3-sized paper.



Beth Kroeger

Latest:

Common Cleanroom Myths

Myths and misunderstanding abound when it comes to microbiology. When it comes to cleanroom and pharmaceutical microbiology, some “myths” have become engrained and even endorsed by regulatory bodies. The authors use logic and sound science to dispel some Microbiological Myths related to Disinfectant Cleaning of Controlled Environments.


Joe McCall

Latest:

Common Cleanroom Myths

Myths and misunderstanding abound when it comes to microbiology. When it comes to cleanroom and pharmaceutical microbiology, some “myths” have become engrained and even endorsed by regulatory bodies. The authors use logic and sound science to dispel some Microbiological Myths related to Disinfectant Cleaning of Controlled Environments.


KORSCH America

Latest:

Critical Requirements of the Mid Range Table Press

Tablet press design innovation has traditionally centered on large-scale production equipment, however, there is increasing focus on the smaller-scale, mid-range models that must have the capability to support product development, scale-up, tech transfer, clinical batch manufacturing, small and medium batch production, and continuous manufacturing applications. This range of capabilities demands unique features and design flexibility.


Pii

Latest:

Cultural Transformations a Necessity to Support Complex Therapeutics Through Development and Manufacturing

President and CEO of Pharmaceutics International, Inc. (Pii), John Fowler, reacts to the agility and flexibility needed to support the development and manufacture of today's complex biotherapeutics.


Adare Pharmaceuticals

Latest:

Expanding Solutions for Challenging APIs Through Coacervation V2

This whitepaper describes the microencapsulation process of coacervation using both aqueous and solvent pathways, and the many benefits for drug developers.


Federal Equipment Company

Latest:

Federal Equipment Company: Supporting CDMO Operations Through Training, Parts, and Equipment

Adam Covitt, President of Federal Equipment Company, discusses how the company enables CDMO successes with its Techceuticals and PharmParts business brands.


Robert Shaw

Latest:

Implementation of Autocorners Algorithm for Retrospective Process Monitoring

The authors present a simple-to-use Microsoft Excel-based statistical tool that uses cumulative sum techniques to aid retrospective understanding of data trends.


Marie South

Latest:

Implementation of Autocorners Algorithm for Retrospective Process Monitoring

The authors present a simple-to-use Microsoft Excel-based statistical tool that uses cumulative sum techniques to aid retrospective understanding of data trends.


LIGHTHOUSE

Latest:

Meeting the Container Closure Integrity Requirements in the Revised EU Annex 1: A Science-Based Holistic Approach

Webinar Date/Time: Tuesday, February 28th, 2023 at 11am EST | 8am PST | 4pm GMT | 5pm CET