Build your pharma development and manufacturing knowledge base with the latest whitepapers, application notes, posters, and other educational resources from bio/pharma industry suppliers.

Spray Drying for Enhancing the Solubility of Poorly Soluble Drugs

Priyanka Haksar, Felix Hofmann, Dr. Firouz Asgarzadeh, Dr. Jessica Mueller-Albers, Dr. Brigitte Skalsky, Evonik Nutrition & Care GmbH

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.

Continuous Twin Screw Extrusion System for Soft Gel Casing Replaces Batch Mixing Operations

Leistritz

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

Comparative Human In-Vivo Study of an Immediate Release Tablet Over-Encapsulated by Gelatin and HPMC Capsules

Capsugel^® Ι Lonza Pharma & Biotech

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.

Six API Challenges That Could be Slowing Your Development

Andreas Stolle, Peter Poechlauer, PhD, Bernt-Dietmar Schober, Patheon-API

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.

Monitoring of Transdermal Drug Delivery in Skin Using the Renishaw Biological Analyser

Renishaw, Inc.

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.

Simultaneous Liquid Chromatographic Analysis of Acetaminophen Impurities

Thermo Fisher Scientific (NPI Umbrella)

This application note demonstrates the capabilities for Dual LC to run independent HPLC and UHPLC methods simultaneously using one instrument.

GMP Testing of Raw Materials Through Containers Using Spatially Offset Raman Spectroscopy

Agilent Technologies

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.

HRAM MAM for Analysis of mAb CQAs

Thermo Fisher Scientific (NPI Umbrella)

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

Is Your In-House Strategy Ready for The Uncertainties of Biologic Drug Development?

Thermo Fisher Scientific (Patheon - Biologics/Sterile), John Ward

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 % to 27 %.

JPEO-CBRND Supports International Partners in Congo Ebola Outbreak

Medical Countermeasure Systems

The JPEO-CBRND has been at the forefront of the DOD's response to the outbreak The JPEO-CBRND contributes to the Ebola support effort with continued development of medical countermeasures to protect, identify and treat the Ebola virus.

Applications in Pharmaceutical Manufacturing

Alconox Inc.

The use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of effectiveness, minimal surface residue, and easier cleaning validation.

The Essential Guide: Cleanrooms and Clean Areas

Rite-Hite Corporation

At Rite-Hite, we have many solutions for the pharmaceutical industry along with the knowledge and experience to help you address the issues you face with your clean areas. We keep up to date on best practices, new design and technology, and the latest trends in the industry.

Understanding 21 CFR Part 11/Annex 11 Compliance

Bob Voelkner, Don DiPalma, LabVantage Solutions Inc.

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.

The Benefits of Low Endotoxin Products

Contec

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