Whitepapers

This whitepaper describes the microencapsulation process of coacervation using both aqueous and solvent pathways, and the many benefits for drug developers.

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

An overview of the various components that go into measuring OEE, and ways product inspection equipment can affect OEE in the pharmaceutical industry.

Single-Use Systems offer biopharmaceutical manufacturers unique benefits in new and existing applications. Emerson’s measurement instrumentation solutions offer newfound flexibility to scale operations.

Optimizing the Manufacture of Cell and Gene TherapiesDescription: Cell and gene therapies are an emerging field that is seeing rapid growth. The manufacture of these advanced therapy products is not yet fully optimized, however, and still carries risks and challenges to process quality, scale up and efficiency. This ebook on Optimizing the Manufacture of Cell and Gene Therapies discusses strategies to making these cell or gene therapy products a success.

Importance of compatibility studies for drug-device products How to test for in-use stability, chemical compatibility, and biocompatibility

- Why having a secondary biocide supplier is important - Information you should gather when selecting a secondary supplier.

Online tool predicts the optimal formulation of drugs New way to predict compressibility and compactibility

• Container closure integrity testing is vital for sterile injectable products. • The Headspace Gas Ingress method is a robust detection method of critical leaks. • This method is an upgrade to the blue dye test and can be scientifically validated.

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.

Screening for developability and solubility issues Assessing pH and food effect when evaluating bioavailability Addressing solubility challenges

In partnership with Honeywell, Axendia research sheds light on opportunities and challenges experienced by leaders trying to modernize their life sciences production.

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

Single-Use Systems offer biopharmaceutical manufacturers unique benefits in new and existing applications. Emerson’s measurement instrumentation solutions offer newfound flexibility to scale operations.

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.

Discover how platforms drive efficiency and get products to market faster. See why data connectivity improves quality and leads to better outcomes. Learn how to transform quality from an obligation to a business accelerator

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