Whitepapers

This paper describes the existing regulatory framework for combined products and focuses on stability testing to assess drug or biological-device compatibility.

A core challenge among drug developers is working with challenging APIs, which are increasingly becoming more hydrophobic and/or with stronger crystal lattice structures, each ultimately poorly water soluble. This ebook covers a variety of important tools for formulators.

* Differentiate the suitability, quality and processability of an excipient. * Recognize the significant impact of superior excipient processability. * Understand the economic return associated with excipient selection.

Learn how regulators define temporary data and how to maintain data integrity. Find out what to look for in a LIMS for 21 CFR Part 11 and Annex 11 compliance.

This article reviews the dangers of endotoxins and the importance of choosing low endotoxin products for product contact areas.

The Thermo Scientific Vanquish Duo system for Dual LC enables two sample runs concurrently, so samples to run in half the time, improving pharmaceutical drug analysis.

The Thermo Scientific Vanquish Duo system for Dual LC enables two sample runs concurrently, so samples to run in half the time, improving pharmaceutical drug analysis.

Most countries are not prepared to respond to infectious disease outbreaks -Military and scientific efforts provide valuable insights for response plans -Lt. Col. Mesngon discusses his role in global health engagement in Uganda

-Higher integrity assurance is needed for single-use systems -An integrity-testing strategy may be required to meet regulatory expectations -New scientific and technological approaches offer stronger integrity

The Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense’s (JPEO-CBRND) Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) entered into a Letter of Agreement for Materials and Information Transfer with Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical companies of Johnson & Johnson on October 2, 2019. The Agreement defines assay validation submission protocol and reporting processes to the European Medicines Agency, and potentially other foreign regulatory agencies and authorities, to expedite its review of Janssen’s vaccine. The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), a component of the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND), aims to provide U.S. military forces and the nation with safe, effective, and innovative medical solutions to counter chemi

This paper outlines the basics of cleaning validation and discusses the support services you should seek from your critical cleaning products supplier to optimize your cleaning validation process.

The market momentum of novel therapies targeting unmet needs is creating a new landscape for pharmaceutical drug manufacturers. As the focus on these smaller patient pools grows, so does the complexity of drug development. Companies must understand how the molecules filling today’s pipeline are changing our business, as they are causing a dramatic shift in how we plan for and execute drug development and manufacturing.

from A technical review of compounding, devolatilization, reactive processing, foaming and direct extrusion via twin screw extruders

The Thermo Scientific Vanquish Duo system for Dual employs two separate flow paths for simultaneous analysis of complex samples.

Identifying counterfeit drugs has become an area of increasing focus for regulatory authorities and also for pharmaceutical companies. Raman spectroscopy is highly specific and can differentiate between materials with similar chemical structures.

from A technical review of compounding, devolatilization, reactive processing, foaming and direct extrusion via twin screw extruders

This application note covers HRAM multi-attribute method for critical quality attribute monitoring and new peak detection, including optimization and application.

This article reviews the dangers of endotoxins and the importance of choosing low endotoxin products for product contact areas.

In this executive summary, experts will present the in vitro dissolution and an in vivo bioequivalence study comparing the performance of the identical formulation of three different drugs in Capsugel® Vcaps® Plus capsules to hard gelatin capsules. In addition, the circumstances under which the same API and formulation contained in HGC and Capsugel® Vcaps® Plus can be expected to provide equivalent performance will be discussed.

The pharmaceutical industry’s past reliance on blockbuster drugs has evolved to include developing drugs that treat the needs of smaller patient populations. These drugs most often come in the form of biologics, which are an increasingly larger share of new drug approvals in the past decade, from 10 percent to 27 percent.

The challenges for new drugs looking to enter the market are numerous. But many are self-inflicted – especially in small molecule development. A dangerous perception persists that aside from highly potent APIs, small molecule medications have simple process requirements. The reality, however, is that most APIs will require numerous steps or significant work upfront to avoid development delays, rework or outright failure.

• How to balance compliance needs with creating useful SOPs. • Tips and tricks for ensuring consistency. • Why and how you should test your SOPs

from A technical review of compounding, devolatilization, reactive processing, foaming and direct extrusion via twin screw extruders

Learn how regulators define temporary data and how to maintain data integrity. Find out what to look for in a LIMS for 21 CFR Part 11 and Annex 11 compliance.

Detecting the presence and depth of penetration of drug compounds in skin can prove challenging, current technologies fail to achieve adequate penetration through layers of dermal tissue. In this study, Raman spectroscopy using the Renishaw Biological Analyser - RA816 confirmed the presence of a topical compound in the epidermis and reticular dermis with high specificity and sensitivity.

This article describes how a Japanese pharmaceutical company successfully implemented the Agilent RapID Raman system for GMP raw material testing through unopened brown paper sacks, and other opaque containers.

This application note covers HRAM multi-attribute method for critical quality attribute monitoring and new peak detection, including optimization and application.

Spray drying continues to gain importance as a preferred manufacturing technology for amorphous solid dispersions (ASD). A fast carrier selection allows for a more targeted development process with reduced time to market. EUDRAGIT® polymers have not only been proven to be superior with respect to ASD formations but can also stabilize the amorphous state of the API over storage.