Whitepapers

This whitepaper details how technological advancements by Syntegon and Corning allow for ultra high speed pharmaceutical fill/finish.

This note demonstrates the misconceptions of Maximum Force Compression. Proper formulation development and tablet design contribute to avoiding max compression force.

The integrity of cleanrooms must be preserved by an effective environmental control program. Selection of a disinfectant and sporicide should be based upon laboratory studies and trials involving in situ testing. The summarized case study demonstrates the efficacy of Vesta-Syde SQ 64 RTU and Spor-Klenz RTU in Grade C/D environments.

Learn how to avoid data integrity breaches and comply with increasingly strict regulatory requirements using informatics for electronic data capture and record-keeping.

Meeting detection challenges presented by nitrosamine impurities Determination of NDMA and nitrosamine impurities using triple-quadrupole LC/MS Determination of genotoxic impurities in ranitidine APIs and drug products

Understanding USP Water for Pharmaceutical Use On-line microbial instrumentation for real-time control of water quality Real-time TOC analysis of water purity

This application note describes key activities to accelerate biopharmaceutical tech transfer to support faster development and manufacturing programs.

Tablet press design innovation has traditionally centered on large-scale production equipment, however, there is increasing focus on the smaller-scale, mid-range models that must have the capability to support product development, scale-up, tech transfer, clinical batch manufacturing, small and medium batch production, and continuous manufacturing applications. This range of capabilities demands unique features and design flexibility.

Drug developers are increasingly using topical dosage forms for numerous reasons, but several factors must be considered to optimize the API's functionality including excipient selection. Trends and Formulation Strategies for Topical Drugs explores this topic and other areas of interest to developers.

-Stability testing for clinical trial materials -New services for oral solid dosage forms -Sourcing global clinical trials in the U.S. and Japan

Whether at the research and development stage, or manufacturing, the inVia Raman microscope offers simple and fast transmission Raman analysis

Explains the purpose, technology, and functionality of Track & Trace in the manufacturing and production process, and the reasons T&T applications have become so important.

-- Innovations in Tablet Press Technology -- Containment for Tableting: Best Practices -- Direct Tableting a Mixture of a Powder Matrix and API Loaded Pellets

-Recent workflow enhancements offer analytical efficiency and speed. -A new molecular spectroscopy method makes sensitive quantitation possible in minutes. -New UV-Vis technology allows simultaneous measurement of standards and unknown samples.

Learn how to use KPIs like Overall Equipment Effectiveness (OEE) to identify and close productivity gaps in batch manufacturing and improve product quality.

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.

This application note shows how hydrocabrons can be an alternative to conventional synthetic refrigerants and a future-proof investment with regard to the EU F-gas regulation.

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.