Whitepapers

An overview of data processing in the HR MAM workflow and demonstration of software for flexibility in different phases of drug development and manufacturing

The following document the emerging threat to the global gelatin supply chain and the dependency of the US healthcare system on foreign supply for key pharmaceutical ingredients.

The ebooklet addresses findings from the Consortium on Adventitious Agent Contamination in Biomanufacturing’s survey of virus contamination experience and mitigating controls and other research, reviews recommended risk management tools to avoid adventitious agent contamination, and provides a framework for a risk management process

This chapter, excerpted from the book Good Distribution Practice, draws on the author’s experience with shipping pharmaceuticals under controlled conditions, particularly over long distances, and his work toward solutions providers in the field.

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.

Bioavailability of insoluble compounds is one of the biggest challenges to drug delivery. Improving bioavailability is crucial to creating dosage forms that are easy to use and meet demands for patient compliance. 

The COVID-19 pandemic has forced countless difficult decisions to be made in the face of unprecedented uncertainty. Patients, consumers, and industry professionals alike are looking for guidance, support, and answers. With increased demand on pharmaceutical manufacturers to develop a COVID-19 therapeutic alongside all the existing treatments that are still needed by millions, there follows the growing need for strict quality control processes, and the ability to test and release large volumes of newly manufactured vaccines.

This ebooklet offers practical advice on the need for SOPs, how to write them, and what should be included in them.

Plan production automation around audit readiness and regulatory compliance. Understand data integrity considerations, infrastructure components, and new technologies supporting GxP. 

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.