Whitepapers

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.

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.

Looking for a binder that keeps up with the demands of continuous manufacturing? galenIQ™ (pharmaceutical-grade Isomalt) is tailored for granulation processes, delivering a balance of performance, processability, and patient compliance. Discover our latest research in this paper.

Discover Fedegari’s Local Expertise with Global Reach. Fedegari combines global manufacturing excellence with local service agility to deliver high-quality, responsive support across North and South America. Learn how our strategic presence and expert teams help pharmaceutical companies optimize sterile process solutions.

Fedegari Training Academy: Building Competence for Evolving Pharma Needs. As pharmaceutical technologies advance, so must the skills behind them. Fedegari’s Training Academy offers hands-on, expert-led programs in a cGMP-compliant environment near Philadelphia—empowering your team to meet modern regulatory and operational challenges with confidence.

Fedegari: Customized Process Solutions for Pharma Manufacturing. Fedegari has evolved into a true solution provider—offering integrated, tested, and regulatory-ready systems tailored to your specific process needs. From process development to tech transfer, discover how our expertise minimizes risk and accelerates implementation.

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).