Whitepapers

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.

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.

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

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

• Accelerated compliance for less expense. • Raman spec streamlines non-destructive processes for production/release

• Raman spectroscopy of streamlining pharma QC and formulation development • Implementing transmission Raman for fast content uniformity testing • Through-container identity verification of polysorbates 20, 40, 60, and 80

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

This app note demonstrates the use of transmission Raman for the quantification of Warfarin in whole intact pharmaceutical tablets at 0.5% w/w with 20 s measurement time

Pharmaceutical companies require marked components for lot traceability but problems occur within secondary processing and with traditional printing methods.

Technology transfers helps sponsors safeguard supply, improve distribution and reduce program costs and risks.

Kidney transporter models are essential for identifying renal toxicity. Learn how immortalized primary renal tubule epithelial models stably expressing OAT1, OCT2 or OAT3 protein were tested for functionality.

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.

In this white paper we look at reverse engineering existing drug products using Raman imaging.

Download the White Paper and learn how detailed characterization can guide successful development of gene therapy products.