Whitepapers

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.

- Advantages of manufacturing immuno-oncology therapies in multiproduct facilities - Preventing cross-contamination and proper cleaning validation

Tablet hardness is essential when formulating a solid dosage form. Certain combinations of commonly used excipients may lead to softer tablets. This study outlines how to avoid those pitfalls and learn which excipients will enhance compaction.

-Research suggests cyclodextrins could replace surfactants for biologics. -Studies on HPßCD indicate it to be a potential alternative to polysorbates.

Myths and misunderstanding abound when it comes to microbiology. When it comes to cleanroom and pharmaceutical microbiology, some “myths” have become engrained and even endorsed by regulatory bodies. The authors use logic and sound science to dispel some Microbiological Myths related to Disinfectant Cleaning of Controlled Environments.

This white paper explains the theory behind the MCA algorithm. Used with in-situ fiber optics, the accuracy is demonstrated by recovering the concentration of two APIs.

This case study looks at considerations for formulations of Mannitol, a versatile excipient used in freeze-dried injectables in the pharmaceutical industry.

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.

What you will learn: * Dosage form innovations can increase patient adherence. * Parvulet offers a solution for patients with swallowing difficulties.

-Micronization improves API bioavailability in new chemical entities. -Increased market demand for micronization has sparked increased CMO services. -Lonza Engine™ provides advantages throughout the drug development process.

2020’s Pharma Manufacturing Trends The world of pharmaceutical manufacturing is changing fast Learn how today’s top pharmaceutical manufacturers are innovating

Bioassays are critical for assessing potency and biological activity during biopharmaceutical activity, but they must be carefully designed to ensure reliability. Learn about new developments in cell-based bioassays and binding assays.

A review of the market dynamics and drug development trends driving strategic outsourcing decisions.

Mahesh Kumar shares background, insights, and results of a study in which a relevant sensitivity and low positive control value in immunogenicity assays are identified.

Study focused on demonstrating the effect of freeze-thaw of conjugated critical reagents on the binding capacity in immunogenicity assay performance.

This paper answers a major concern of manufacturers: Do x-rays affect the quality and efficacy of a drug during product inspection?

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