Whitepapers

This technical brief will cover the use of polymers in a variety of dosage forms (buccal/sublingual tablets, liquid, semi-solid formulations, and oral care products) to impart mucoadhesion. The basic mechanism of mucoadhesion and methods to evaluate it in the context of pharmaceutical applications will also be reviewed, also how it can improve and differentiate drug products.

Cell-based assays (CBAs) are key tools for evaluating the potency of new biologic drugs. Catalent’s transcription-based bioassay simplifies and empowers the testing of new biologics.

In this rapidly changing environment, your choice of CDMO partner is critical. The right partnership can serve as your key to commercial success, while the wrong one can lead to costly delays, quality issues and compliance risks. To help you overcome your OSD challenges and drug product manufacturing challenges and streamline your journey to commercialization, our experts have developed an eBook to help you find the right CDMO for your project.

This whitepaper explores the importance of safe cGMP pharma product storage, highlighting challenges CDMOs face with inventory bottlenecks and delays. It examines off-site cGMP storage benefits, including cost savings, flexibility, and compliance, while addressing key factors for maintaining product safety and accessibility.

Elemental impurity testing is essential to deliver safe drug products to patients and is a regulatory requirement. It is important to assess the risk of elemental impurities from all sources in the manufacturing process, including process equipment, water, container/packaging, raw materials, drug substances, and the final drug product.

Compendial testing covers a wide array of materials, subjects, and locations designed to create standards and programs that ensure the quality and safety of approved articles for a geographical location or areas such as USP (For the United States market) or Ph Eur (For European markets). The compendia provide monographs and test methods for active ingredients, raw materials, drug products, utilities (water and gases), and packaging components.

Revolutionize pharmaceutical manufacturing through paperless manufacturing. By eliminating paper-based processes, you can quickly centralize your data, reduce cost and time, minimize errors, and release products faster. Even the simplest “paper on glass” digital systems enable streamlined workflows and can ensure real-time data access and seamless communication. Paperless facilities are a reality! Transform your operations today!

Amid surging drug shortages and costly launch delays, it’s crucial to enhance operational flexibility and efficiency without compromising quality. Discover how end-to- end integrated automation systems can streamline your processes, improve flexibility, reduce time-to-market, maximize revenue, and drive continuous improvement. Transform your pharmaceutical manufacturing processes today!

This case study explores the deployment of an innovative logistics solution designed to support the survival of premature infants through the rapid collection, retrieval and delivery of essential, temp-sensitive supplements to hospitals in Sydney, Australia. Storage specifications for the supplements was -20°C with instant availability required upon order. Retrieval was immediately followed by expedited delivery at -80°C with dry ice. Executed by Marken, this project required a comprehensive system enabling immediate access, and transportation of these critical supplements, ensuring they reach newborns in regional hospitals when every second counts.

Get a glimpse of the power and popularity behind the PDA Pharmaceutical Microbiology Conference from two planning committee members, Julia Marre, PhD (Associate Director, Scientific and Regulatory Affairs at Pocket Naloxone Corp) and Dawn Watson (Executive Director, Global Micro Quality and Sterility Assurance at Merck). This candid conversation reveals why this industry event is so influential…and always sold out! The speakers discuss what makes the PDA Pharmaceutical Microbiology Conference so vital to industry professionals, as well as how to become a part of this dynamic professional community.

Harmonizing technological innovation and a platform approach in biomanufacturing can reduce time and cost barriers to produce stable, high-expressing antibody-based therapeutics

By integrating QbD into the development process, organizations can achieve robust manufacturing processes, regulatory compliance, and commercial success.

In vitro transcription (IVT) is often used to make mRNA, and in co-transcriptional capping an analog cap can be used to cap the mRNA. This paper reviews the recent history of capping analogs in addition to a state-of-the-art approach to improve protein expression.

Drug stability impacts efficacy and safety. Choosing the right packaging is crucial. This paper outlines key factors affecting stability and provides packaging guidelines.

Ecolab is looking to the future with new opportunities to partner with Pharma for critical solutions to support drug development and manufacturing.

This whitepaper provides an overview of developing a comprehensive contamination control strategy (CCS), taking into consideration the various aspects of pharmaceutical manu