Authors


Ryan McNulty

Latest:

Considerations for Seals in Split Butterfly Valves

Materials used in the seals of split butterfly valves for aseptic pharmaceutical manufacturing should be chosen carefully.




Yurii Pidpruzhnykov

Latest:

A New Method for Risk Assessment of Pharmaceutical Excipients

This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.


Tetiana Kolisnyk

Latest:

A New Method for Risk Assessment of Pharmaceutical Excipients

This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.


Olena Ruban

Latest:

A New Method for Risk Assessment of Pharmaceutical Excipients

This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.


Pete Dawson

Latest:

How to Achieve Pharmaceutical Dust Control

This article presents considerations for preventing hazards associated with dust in pharmaceutical production, particularly as relates to the United Kingdom's Control of Substances Hazardous to Health (COSHH) Regulations.


Pia Isabel Tan

Latest:

Formulating Topical Products Containing Live Microorganisms as the Active Ingredient

Case studies compare efficacy testing of preservatives for topical formulations with probiotic actives.


Yug Varma

Latest:

Formulating Topical Products Containing Live Microorganisms as the Active Ingredient

Case studies compare efficacy testing of preservatives for topical formulations with probiotic actives.


Jason Carbol

Latest:

Formulating Topical Products Containing Live Microorganisms as the Active Ingredient

Case studies compare efficacy testing of preservatives for topical formulations with probiotic actives.


Malcolm Horsley

Latest:

Outsourced Manufacturing Operations

Manufacturers are facing ever-increasing competition while end users are expecting better value and efficacy. The authors discuss these challenges and offer practical solutions.


Bir Gujral

Latest:

Model-Based Simulation: Getting Comfortable with Randomness

Twenty-first century drug development challenges sponsors and contract partners to collaborate more closely, using tools such as model-based simulation.


Nicola Tirelli

Latest:

Improving Nanoprecipitation Control

The performance of nanoparticles used as carriers in drug delivery is intimately linked to their physical properties. Nanoprecipitation is a common method for the preparation of drug-loaded polymer nanoparticles, but until recently, the reproducibility of the two primary dimensional descriptors-the average particle size and the breadth of the size distribution-has been a challenge due to the intrinsic variability of batch processes. Microfluidics-based flow techniques, however, reduce variation in drug-loaded polymer nanoparticle synthesis.


Regis Cazes

Latest:

A QbD Approach to Shorten Tablet Development Time

Tableting instruments (i.e., compaction simulators) that simulate high-speed presses can be used in a quality-by-design (QbD) approach to perform in-depth material characterization and direct scale-up.


Lennart Eriksson

Latest:

Characterizing a Bioprocess with Advanced Data Analytics

Advanced data analytics tools are used by industry to find the golden nuggets in historical data, to aid in process development, to fine-tune production, and to achieve long-term improvements in product quality and throughput.


Chris McCready

Latest:

Characterizing a Bioprocess with Advanced Data Analytics

Advanced data analytics tools are used by industry to find the golden nuggets in historical data, to aid in process development, to fine-tune production, and to achieve long-term improvements in product quality and throughput.


Eva Weber

Latest:

Automating Pharmaceutical Packaging Inspection

Machine vision and optical character recognition technologies enhance inspection of packages and labels.


Jasdip S. Koner

Latest:

Dry Particle Coating—A Unique Solution for Pharmaceutical Formulation

Aston Particle Technologies has developed a technology that produces functionalized particles in a one-step, environmentally friendly process.


Linda Joy

Latest:

Good Quality Agreements Support Compliance with CGMP

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


David A. Wyatt

Latest:

Dry Particle Coating—A Unique Solution for Pharmaceutical Formulation

Aston Particle Technologies has developed a technology that produces functionalized particles in a one-step, environmentally friendly process.


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.


Eman Z. Dahmash

Latest:

Dry Particle Coating—A Unique Solution for Pharmaceutical Formulation

Aston Particle Technologies has developed a technology that produces functionalized particles in a one-step, environmentally friendly process.


Afzal Mohammed

Latest:

Dry Particle Coating—A Unique Solution for Pharmaceutical Formulation

Aston Particle Technologies has developed a technology that produces functionalized particles in a one-step, environmentally friendly process.


Amjad Alhalaweh

Latest:

High Throughput Screening of Excipients

The author discusses the advantages of high-throughput screening of drug formulation excipients by a fully automated Tecan-robotic system.


Peter Scholes

Latest:

Removing the Bitter Taste from Drug Development

Integration of formulation development, real-time adaptive GMP manufacturing, and clinical testing using a consumer preference panel can save time and cost in performing taste-masking assessments.


Minzhang Chen, PhD

Latest:

Transition From Clinical to Commercial Supply Chain-Regulatory Starting Materials

The authors discuss expectations of regulators on the selection of drug substance regulatory starting materials (RSM) and the justification of their designation in the pharmaceutical supply chain, the scope of the RSMs' presentation required in regulatory filings, and how to mitigate and prepare for "push backs" in the event of a major objection to the sponsor's RSM designation.


Valdas Jurkauskas, PhD

Latest:

Transition From Clinical to Commercial Supply Chain-Regulatory Starting Materials

The authors discuss expectations of regulators on the selection of drug substance regulatory starting materials (RSM) and the justification of their designation in the pharmaceutical supply chain, the scope of the RSMs' presentation required in regulatory filings, and how to mitigate and prepare for "push backs" in the event of a major objection to the sponsor's RSM designation.


Karen Redding

Latest:

Why Good Records Management Is Key

The past year has seen significant consolidation of mid-size CROs, with many of them being bought or put up for sale. In particular, the top six or seven CROs seem to be signing more preferred partner deals, such as Pfizer teaming with Parexel and ICON, and Takeda?s deals with Covance and Quintiles, which is driving mid-size CROs growth through major acquisitions.