Whitepapers

Developers of innovative drug products dealing with protein formulations, nucleotide-based drugs, peptides, and poorly soluble molecules, face significant challenges in achieving efficient and scalable manufacturing solutions. Spray drying has emerged as a powerful and versatile manufacturing technology. It offers significant advantages for stabilizing complex and sensitive drug molecules while optimizing production processes. Join our panel of experts as they explore how spray drying can be applied to enhance the stability, bioavailability, and manufacturability of various molecules, including peptides, oligonucleotides, small molecules, monoclonal antibodies, and nutraceuticals. This session will cover the latest innovations in spray drying technology, and provide valuable insights into formulation development, process parameters optimization, and large-scale production. Attendees will also learn how to maintain molecular integrity during the spray drying process and leverage in-silico tools to streamline commercialization.

Pharmaceutical micronization plays a pivotal role in enhancing the efficacy and bioavailability of many active pharmaceutical ingredients and the need for robust, repeatable and precise particle size control is critical. This article provides an in-depth review of milling equipment, including jet, pin, hammer, conical and cryogenic mills. Each technique is influenced by material properties like hardness/brittleness, morphology, and moisture content, as well as milling parameters such as feed rate, grinding pressure, mill speed and temperature. By selecting the right milling equipment and optimizing its operation, pharmaceutical innovators can ensure that their products meet the highest standards of quality, efficacy, and safety.

Precise cold chain management is essential to safeguard biologics, but traditional ULT freezers can’t keep pace with the demands of modern drug development.

This infographic explores the benefits of Acoustic Ejection Mass Spectrometry (AEMS)- based workflows for efficient small and large molecule screening.

This white paper provides an overview of key units in the DSP skid train, including chromatography, ultrafiltration/diafiltration, viral inactivation, and optional operations like centrifugation and refolding. Critical process parameters (CPPs) associated with each operation are discussed, along with the analytical process sensors used to monitor them.

Get a better understanding of pH measurement in Hamilton’s comprehensive pH Measurement Guide. This 68-page booklet is intended for anyone with an interest in pH sensor technology or anyone who needs to implement pH sensors in controlled environments such as laboratories and industrial plants.

Download our White Paper and learn about quality attributes, critical process parameters, and key performance indicators at the bioreactor. Our White Paper provides a comprehensive, but accessible, overview of requirements and recommendations related to the FDA's Process Analytical Technology (PAT) initiative for the biopharmaceutical industry.

As a leader responsible for metabolite identification in your organization, what keeps you awake at night? SCIEX can give you peace of mind by helping you . . .

We understand you are busy, needing to prioritize running instruments, reporting results and managing your laboratory to meet deadlines. We created this solution guide to explain how SCIEX systems fit in the drug development pipeline to save you time evaluating options. This guide covers bio/pharmaceutical quantitative assays from discovery to QA/QC, for large and small molecules. Happy reading!

Explore how next-generation high-performance liquid chromatography (HPLC) systems are elevating biopharmaceutical analysis. This eBook showcases innovations in size-exclusion chromatography (SEC), method updates, and proven approaches to increase efficiency, consistency, and resolution in the lab.

Bill speaks on our Winnipeg site’s historic excellence in bringing product from development to commercialization.

This multi-pager tells the story of Emergent’s Strategic Manufacturing Partnerships, highlighting our capabilities, unique partnership models, and history of manufacturing excellence.

Discover how pharmacy-led models in direct-to-patient clinical supply are pivotal in modernizing clinical trials, offering scalable, patient-centric solutions that align with regulatory guidance and industry trends. Strategic collaboration with pharmacy providers is the key to unlocking the full potential and benefits of decentralized clinical trials (DCTs).

Global decentralized trials require fast, efficient, and sustainable clinical supply solutions. This case study shows how a biopharma company worked with Catalent’s FastChain® demand-led model to improve supply by reducing waste and shipments by 40%, speeding patient dosing to under three weeks, and enabling flexible, decentralized packaging and distribution, whilst supporting an eco-friendly trial management worldwide.

Learn how scalable single-use systems can support reliable process performance and manufacturing flexibility.

Choosing the best location for packaging and distributing clinical supplies depends on various study factors and business needs. There’s no one-size-fits-all answer, but by evaluating key considerations, sponsors can determine whether the EU or non-EU countries like the UK best fit their clinical supply strategy.

China is a key player in global clinical trials, yet its intricate regulatory environment and logistical challenges demand meticulous supply chain management. Catalent provides tailored services such as Free Trade Zones, temperature-controlled shipping, and local comparator sourcing to support sponsors in executing trials effectively and in compliance with regulations.

Discover how automated plasmid purification can free up your lab's workflows and increase efficiency, scalability, and consistency without compromising quality. Get your copy of our eBook to explore real-world insights, actionable strategies, and innovative products you need to future-proof your pDNA purification processes.

Plasmid DNA purification has a vital role in molecular biology research. pDNA isolated at maxi scale is utilized in a variety of downstream applications, including mRNA synthesis, vaccine development, antibody production, cell and gene therapy and viral vector production. Learn about this new automated process.