An environmental risk assessment (ERA) is now required for all new pharmaceutical product marketing authorisation applications. The author outlines the steps to this procedure.
What do you need to ask during the vetting and selection process to ensure your clinical or commercial program won’t be derailed by a quality-related problem?
In this application note, we pair Simple Plex Assays on Ella with Cygnus 3G CHO antibodies for superior sensitivity and data reproducibility throughout bioproduction.
The 2D Data Matrix barcode is a familiar sight for most pharmaceutical manufacturers as printing is implemented to meet certain regulations.
Leveraging real-time MRI guidance for intracranial gene therapy administration potentially improves efficacy and outcomes.
Digital transformation allows for smarter and connected biomanufacturing operations.
Experts in solid dosage technology, offering electrostatic spray dryers, fluid bed systems, and other process solutions used daily to help the pharmaceutical, nutraceutical, food, fine chemical, and biopharmaceutical industries.
This paper explores the relationship between investing in pharmaceutical manufacturing risk reduction and meeting business objectives.
The manufacture of high potency active pharmaceutical ingredients (HPAPIs) is on the rise with R&D projects showing a continuing interest in these products.
A phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.
The authors developed a reliable spectrophotometric method for determining and measuring trace amounts of lead in various samples.
FDA is anticipating how AI may advance manufacturing and improve supply chain security.
This review provides an update of how dendrimer technology is being applied to the development of novel systems for various topical delivery applications.
Research suggests that intranasal nanosuspensions offer a promising way to formulate and deliver drugs that are poorly soluble in water to patients with chronic conditions.
An integrated platform that keeps real-time data in a single location can be a major asset for pharmaceutical companies, as it saves time and money, leading to better quality products and higher profits.
***Live: Tuesday, November 24, 2020 at 9am EST| 2pm GMT| 3pm CET*** Coloring as an aesthetic value for a product is becoming more important for pharmaceutical and nutritional products and helps differentiate between various grades of active ingredients. This webcast introduces the world of easy coloring, answers questions about pigments, pigment blends, and how to color solid- or liquid-dosage forms in an efficient way. Register for this webcast to learn how ready-to-use coloring systems can simplify production process.*** On demand available after final airing until Nov. 24, 2021.***
An effective data structure and simple communication between production, logistics, and sales are essential for delivering this level of accountability, traceability, and security.
The author discusses some new applications of TPGS in the pharmaceutical field that should see this versatile excipient retain its place in the drug formulators toolbox.
Challenges in fermentation can be addressed through equipment changes, facility design, and process development.
Lean delivery offers a promising solution to supply and manufacturing bottlenecks by integrating project teams early on and widening the team’s field of view.
Webinar Date/Time: Tue, Dec 3, 2024 11:00 AM EST
The rising complexity of clinical research protocols has necessarily expanded the CRO landscape.
Capturing and curating R&D data are crucial to realizing the full value of advanced analytics.
An updated book summarizes recent research for formulators and drug-delivery specialists.
More attention should be given to how expert opinions and judgments are elicited for reducing uncertainty in quality risk management and risk-based decision making.
Opposition to IP protection for COVID-19 vaccines, therapies, tests and other technologies may only prevent eradication and treatment of the disease.