Requirements for virus filtration must be considered in developing continuous downstream processes.
The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with the requirements of the product.
The inVia™ Qontor® microscope's optical tweezing performance depends on the optical properties of the particles and the medium. Typically, it can trap particles smaller than 10 ?m.
Shear-sensitive ingredients in a tableting formulation experience different conditions in a batch tumble blender than they would in a continuous paddle blender.
Attend this webcast to hear Jacob Butler, quality control specialist at Organon Teknika Merck, describe his experience with manual solvent and oven extraction method development. Jacob will present a case study that demonstrates both determination of optimal oven temperatures and how to build an oven method for method validation. Live: Wednesday, Aug. 14, 2019 at 1pm EDT | 12pm CDT | 10am PDT On demand available after airing until Aug. 14, 2020 Register free
Are investigations supporting or hindering performance excellence?
Using risk assessment properly can provide industry with a unique tool for quality control.
A variety of strategies have been employed to deliver proteins and peptides in improved parenteral formulations and/or via noninvasive routes.
Consider the purity of exhaust air emitted by vacuum pumps in addition to the purity of compressed air used in the pharmaceutical process.
Shear-sensitive ingredients in a tableting formulation experience different conditions in a batch tumble blender than they would in a continuous paddle blender.
Shear-sensitive ingredients in a tableting formulation experience different conditions in a batch tumble blender than they would in a continuous paddle blender.
Prior to use in a continuous manufacturing system for oral solid dosage forms, loss-in-weight feeders need to be tested and validated to understand the performance capabilities of a given material–feeder combination. In this article, the proper strategy for set-up and optimization of a loss-in-weight feeder is demonstrated for a range of materials. The optimized set-up of the feeders was demonstrated to provide suitable performance for even the most challenging, poorly flowing materials.
USP offers a growing portfolio of well characterized monoclonal antibody (mAb) reference standards and associated characterization data.
Pharmaceutical Technology® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about the use of artificial intelligence and machine learning in pharmaceutical development and manufacturing.
Pharmaceutical Technology® sat down with Stefan Verheyden, Global Vice President Sales Pharma & Biopharma Solutions Injectables at Gerresheimer, to talk about the primary and secondary packaging solutions Gerresheimer and Bormioli Pharma will be showcasing at Pharmapack Europe 2025 in Paris, France from January 22–23.
With COVID-19 vaccine facilities receiving recent citations, it is evident that failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.
The COVID-19 pandemic is pushing more companies to adopt just-in-time practices, but success demands careful upfront risk assessment and planning.
Efforts to tackle challenges in tablet manufacture are shaped by quality by design (QbD) and continuous manufacturing.
To ensure the safety and efficacy of biologic drug products, the materials that come in contact with the drug must be fully characterized to determine their impact.
Lipid-based formulations offer a means of addressing the physicochemical and biological challenges of poorly soluble APIs.
Innovations in glass and plastic syringes reduce waste and increase safety.
Packaging and packaging line innovations are addressing the industry’s growing use of biologics.
New technologies improve efficiency and remove operator intervention.
As a GMP manufacturing method, 3D printing offers benefits for modified release and personalized dosages.
Moisture uptake during the end-to-end manufacturing process and supply chain can affect product quality. Simulation tools based on mechanistic models help define storage and handling requirements for oral solid-dosage drugs.
This article looks at five of the most common hurdles in packaging and labelling artwork and how to avoid them.
Quantitative and qualitative tools allow better understanding of mixing in a single-use bioprocessing system.
Hot-melt coating was used to develop taste-masked orally disintegrating granules of acetaminophen and caffeine.
Hot-melt coating was used to develop taste-masked orally disintegrating granules of acetaminophen and caffeine.