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

When Drug Meets Device

Ruth Verplaetse PhD, Lise Vanderkelen PhD; Nelson Laboratories, LLC

When a medicinal product (drug or biologic) meets a medical device, a combined product is created. Incompatibility between the components can present a danger to the patient, but how can one demonstrate the compatibility between a medicinal product and a device? This paper describes the relevant definitions and existing regulatory framework for combined products.

Size Doesn’t Matter… Under Pressure

Gary Bubb; Specialty Measurements Inc.

Evaluating the properties of different tablet sizes through normalization. This will be accomplished by using compression pressure, rather than compression force and tensile strength versus breaking force (hardness).

Analysis Using Counter-Rotating Twin Screw Extruder

Charlie Martin, Brian Haight, Augie Machado, Abbe Haser, Feng Zhang; Leistritz Extrusion

Various extrusion operating conditions and formulations were used to enhance the solubility and recovery of meloxicam (MLX) in copovidone to near 100% on a counter-rotating twin screw extruder (TSE).

Containing Cytotoxic Product During Transport

Cameron Faulconer; Flow Sciences, Inc.

The purpose of this document is to serve as a case study where a containment device was designed to facilitate “interim containment”, or containment during the portion of a process where the product isn’t inside the enclosure.

Quantitative Analysis of Warfarin Tablets Containing Salt-Form Impurities Using Transmission Raman Spectroscopy

Julia Griffen; Agilent Technologies

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

Advanced Renal Models for Toxicity Screening

Chaozhong Zou, Ph.D., Luis Romero, M.S., Elizabeth Turner, Ph.D., Brian A. Shapiro, Ph.D., Penney McWilliams-Koeppen, M.S., Brian Chase, M.S.; ATCC

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.

Manufacturing Process Scale-up for Phase III: Clear Sailing or Storms Ahead?

Sanjay Konagurthu, Ph.D, John W. Burke; Patheon

Regardless of whether your group has been diligently planning for scale-up since Phase I or you have delayed scale-up work until now, it would be a mistake to assume Phase III will be clear sailing. The reality is that several manufacturability problems could be brewing that will rain down during Phase III and cause costly delays, no matter how skilled the product and process development teams may be.

Is Your In-House Strategy Ready For The Uncertainties Of Biologic Drug Development?

John Ward, Vice President, Engineering; Thermo Fisher Scientific

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.

Cleaning Validation for Pharmaceutical Manufacturing

Alconox Inc.

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.

JPEO-CBRND Supports International Partners in Congo Ebola Outbreak

Hannah Feldman and Rachel Overman, JPEO-CBRND, Joint Project Manager; Medical Countermeasure Systems

Teams from the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, or JPEO-CBRND, provide continuing support to the Ebola virus outbreak response in the Democratic Republic of the Congo, or DRC, and neighboring countries.