Whitepapers

Simple Plex™ Assays on Ella™ are hands-free, fast and reproducible immunoassays that eliminate all manual steps of traditional ELISAs. In this application note, we pair Ella with the industry leading Cygnus Technologies 3G CHO antibodies to bring you superior assay sensitivity and data reproducibility throughout the manufacturing process.

This technical paper outlines a method to apply a structured optimization template to an existing tablet compression process to maximize output and product quality.

This white paper looks at the aggregation process, which defines the track and trace data relationship between the parent and child.

Eurofins’ whitepaper discusses insourcing & outsourcing solutions to solve challenges with meeting drug development timelines and budgets with restricted headcounts.

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 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.

This technical paper outlines a method to apply a structured optimization template to an existing tablet compression process to maximize output and product quality.

-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.