Authors



Thomas J. Joyce

Latest:

Pharma Services Sector Poised for Continued Growth and Consolidation

The CRO market will see greater consolidation by both financial buyers looking to consolidate smaller players and larger CRO players wanting to expand into value-added specialty service areas.


Tanya Landon

Latest:

Trends in International Arbitration: The Fallout from COVID-19

As a result of the disruptions caused by the COVID-19 pandemic, global arbitration has adapted to a ‘new normal’.




Ramesh Raju Mavuleti

Latest:

Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in Biomanufacturing

Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.


Gary Liversidge

Latest:

Nanotechnology: A lifeline for drying pharma pipelines?

Pharmaceutical Technology Europe spoke with experts about the developments that have shaped the nanotechnology industry today and the benefits that this technology has to offer the pharmaceutical industry, which remain largely untapped.


Mike Eaton

Latest:

Nanotechnology: A lifeline for drying pharma pipelines?

Pharmaceutical Technology Europe spoke with experts about the developments that have shaped the nanotechnology industry today and the benefits that this technology has to offer the pharmaceutical industry, which remain largely untapped.


S Gebert

Latest:

Development of Orally Disintegrating Tablets Based on a New Excipient

The authors examine the effectiveness of an excipient comprised of mannitol, polyvinyl acetate, and crospovidone using model actives loperamide hydrogen chloride and caffeine.


Benjamin Ziehr

Latest:

Analytical Strategies for Cell and Gene Therapy Development

Developing bioassay methods requires a new approach for cell and gene therapy drug development.


Bryan Thompson

Latest:

Demystifying Complex Clinical Trial Kit Preparation

Best practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.


Parul Angrish

Latest:

Development of a Validated Method of Testing for NDMA in Ranitidine

This article describes a validated method, using liquid chromatography/mass spectrometry, for detecting the carcinogenic impurity NDMA (N-nitrosodimethylamine) in ranitidine that meets and exceeds FDA’s limit of detection and limit of quantitation requirements.


InProcess-LSP

Latest:

Continuous Inline Size Monitoring of Low Turbidity Nanosuspensions

Find out how the NanoFlowSizer’s THALIA system is capable of measuring particle size in continuous liposome manufacturing with low lipid concentrations, below 3 mg/mL.


Sanjay Sharma

Latest:

Assessing Legacy Drug Quality

A data-driven strategy can assess the quality of legacy drugs developed before 2011 process-validation requirements were established.


Naresh Talwar

Latest:

Novel Formulations and Line Extensions with Soft Capsule Technology

Advancements in soft capsule technology can enable the development of soft capsule formulations, which are becoming the preferred method of oral administration.


Element Materials Technology

Latest:

Embracing Agile Methodology for E&L Excellence

Delivery of robust E&L programs by leveraging Agile software development methodologies in the laboratory.


Matt Lowe

Latest:

Viewpoint: Digitizing Processes to Align with GMP Requirements

The case for migrating from a paper-based quality management system to a digital platform is presented.


Jing Liu

Latest:

Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug Development

Extrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.


Graham Smith 

Latest:

EU Anti-Counterfeiting Legislation On Its Way

In order to combat the threat of counterfeits in Europe, the EU's current anti-counterfeiting directive is being amended.



Simona Bertolini

Latest:

Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms: Part 1

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.


Experic

Latest:

Challenges and Triumphs in Next-Generation Biotherapeutic Development

Webinar Date/Time: Fri, Dec 13, 2024 11:00 AM EST


Ian Lancaster

Latest:

Trends: Holograms and Anticounterfeiting

Sophisticated replication techniques have made counterfeiting and fraud a serious threat to the pharmaceutical industry.


Shahrzad Missaghi

Latest:

The New Digital Era for Formulation Development

A new generation of interactive formulation development platforms can leave trial and error in the formulation process in the past.


Markus Stuebchen

Latest:

Using Robotics in the Aseptic Manufacturing Facility of the Future

Several steps need be taken to achieve lights-out, fully automated operations.


Barbara Scott

Latest:

Master File Submission of Structures

The SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.


INTERPHEX

Latest:

Technology Forum: The Next Steps for Pharma Manufacturing Efficiency and Effectiveness

Wednesday, September 15, 2021 at 10am EDTDrug manufacturing demands and increased regulatory oversight are prompting pharmaceutical manufacturers to consider new processes for oral solid dose and aseptically processed drugs. A cross-section of industry experts will offer insight on emerging trends, technologies, and processes in this Technology Forum.


David E. Szymkowski

Latest:

True Biosimilars Do Not Offer A Compelling Business Case

Why the primary defence against biosimilars is to develop better molecules that can be launched quickly.


CapsCanada

Latest:

The versatility and value of liquid-filled hard capsules

This article discusses the benefits and advantages of liquid-filled hard capsule manufacturing from formulation, development and full-scale production


Nevin Witman

Latest:

Delivering on the Potential of mRNA Therapeutics

The complexity of the RNA production process creates challenges.