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.
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).
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.
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.
The landscape of cell and gene therapy is rapidly evolving, with increasing approvals for diverse indications. Preserving the integrity and efficacy of cell and gene therapy products is critical. Vial adapters facilitate the transfer of drug product from a vial by securing an efficient connection between the vial and the administration device. Learn more about how sterility and accurate dosing are maintained while preserving stability.
The road to market access is long and complex. Choosing a CDMO with experienced staff can prove vital to success. In this executive summary, Praveenkumar Devakadaksham and Dr. Roché Marcel Walliser explain all the ways they help make the journey from pharmaceutical development to commercial distribution as smooth as possible. Learn more about:
