Whitepapers

AI-powered prognostics used in histopathology can reveal complex patterns in tissue and cells that exceed human vision capabilities. We present how the incorporation of these models into laboratory workflows creates more objective, reproducible, and scalable processes. This affords greater diagnostic accuracy, faster turnaround times, and patient care that best fits their needs. By handling variability and subjectivity in traditional methods, this approach supports more confident prognoses and better clinical outcomes.

Diagnostic tool for predictive maintenance in lyophilizers: an anomaly detection algorithm that flags abnormal patterns to cut downtime and costs.

Learn how a custom ADA assay was designed, incorporating acid dissociation with the ACE method to overcome drug interference using other standardized formats.

Having a robust immunogenicity assay for accurate evaluation of ADA in animal models is important for enabling effective decision-making during development. Learn how a robust anti-drug antibody assay was developed and was capable of detection at the requisite sensitivity and enabled meaningful interpretation of PK data obtained from the preclinical animal model.

Learn the unique considerations for use of ADA assays in early development, pre-clinical and clinical settings, as well as how to generate high-quality methods at each stage to support successful development and regulatory approval of safe and effective biotherapeutic drugs.

The identification of drug metabolites is a critical step in drug development due to their impact on drug efficacy and safety. LC-MS platforms provide good selectivity and sensitivity making it the preferred technique for metabolite identification. Here, metabolite identification was performed using unique fragments from EAD and CID spectra. Fragment information from EAD and CID spectra were processed in a single result file to achieve confident structure assignment of and localization of metabolites.

Learn about the end-to-end solution for metabolite identification from method development to analysis.

Throughout drug development, it is important to characterize and quantify pharmaceutical compounds and any associated metabolites to ensure proper drug safety and efficacy. LC-MS/MS techniques are predominantly used for such analyses because they provide a comprehensive outlook and can offer a sensitive and selective approach for the quantification of compounds. However, limited deep fragment coverage and sensitivity challenge the confident identification and quantification of metabolites and drug products. Here, alternative fragmentation paired with a highly sensitive QTOF system was employed for comprehensive data collection to properly identify metabolites and quantify complex peptide therapeutics.

Discover how the targeted metabolomics screening workflow employing integrated SCIEX OS Software with the X500 QTOF System can benefit your lab.

This technical note describes the identification of pioglitazone phase 1 metabolites from a hepatocyte incubation using comprehensive spectral data from an orthogonal fragmentation technique. More informative MS/MS spectra provided by EAD aided in the software-based identification of phase 1 metabolites to support drug metabolism studies.

This case study outlines how a European contract manufacturing organization (CMO) proactively responded to the revised EU GMP Annex 1 regulations, which introduced stricter requirements for sterile drug packaging, contamination control, and quality assurance. Faced with the challenge of selecting the right stopper quality for a diverse customer base while ensuring regulatory compliance, the CMO needed to improve particulate specifications and demonstrate a phased contamination control strategy aligned with Annex 1 expectations.

This article answers key questions about the revised EU GMP Annex 1, which sets stricter standards for sterile drug manufacturing, including contamination control strategies, personnel training, and the use of modern barrier technologies like RABS and isolators. It explains the rationale behind the revision, its impact on both new and marketed drugs, and how manufacturers must adapt to meet heightened regulatory expectations.

Manufacturers of sterile medicinal product. Entire supply chains entered a new era with the August 2023 EU GMP Annex 1 updates, all of which ultimately focus on enhanced public health protection. This article outlines the pharmaceutical manufacturers requirements to develop a comprehensive contamination control strategy that documents their assurance of sterile drug quality and patient safety.

This whitepaper by West Pharmaceutical Services explores how pharmaceutical manufacturers and suppliers can confidently navigate the revised EU GMP Annex 1 guidelines for sterile drug production. It outlines the challenges posed by the new requirements—especially around implementing a robust contamination control strategy (CCS)—and shares West’s proactive, data-driven approach to compliance.

This whitepaper provides a comprehensive overview of how pharmaceutical manufacturers can achieve compliance with the revised EU GMP Annex 1 regulations, which mark a significant shift in the standards for sterile medicinal product manufacturing. Particular emphasis is on a holistic, risk-based approach to contamination control across the entire supply chain.

Nasal drug delivery has been around since the 1950s when it was used for over-the-counter (OTC) decongestants. In the current pharmaceutical industry, it is used across biologics, small, and large molecule applications, and even has potential for neurodegenerative diseases like Alzheimer’s because it can pass the blood-brain barrier and first-pass metabolism.

Discover how Fedegari’s FOB5 is redefining sterilization with compact design, GMP compliance & high-containment capabilities.

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.

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.