Viewpoint: Continued dialogue among pharma stakeholders is needed to achieve consensus regarding excipient composition.
Method-transfer kits help simplify analytical method transfer for global site certifications.
The authors describe the methods by which precise analyses of stable-isotopic abundances can be used in security and forensic applications for pharmaceutical materials. These methods include product and process authentication of raw materials, pharmaceutical intermediates, drug substances, formulated drug products, and synthetic pathways. Collectively, these methods can be used to investigate and mitigate patent infringement. In the future, more complete examples will be presented containing full isotopic results and the application of the methods described in this article.
Product variability from biopharmaceutical manufacturing to storage can significantly impact the safety and efficacy of batch-to-batch products during clinical use.
Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling.
BENEO produces galenIQ™, a water-soluble filler and binder. galenIQ™ has a sweetness and taste profile similar to sucrose, therefore it’s used to improve palatability of bitter-tasting active pharmaceutical ingredients and plant extracts.
Regulatory, analytical, and process concerns must be taken into account.
This article reviews a range of techniques available for separative analysis of mRNA therapeutics, their associated impurities, and delivery vehicles.
Predictive computational methods are finding wider use in pharmaceutical solid dosage development, particularly in mixing and blending, to improve tech transfer and equipment selection, and speed the acquisition of process understanding.
For drug sponsors that are considering building their own manufacturing facilities, an expert project team is crucial.
The authors review the current regulatory framework for the selection of drug substance starting materials.
Pharmaceutical Technology Europe spoke with experts about the developments that have shaped the nanotechnology industry today and the benefits that this technology has to offer the pharmaceutical industry, which remain largely untapped.
Webinar Date/Time: Wed, Oct 11, 2023 11:00 AM EDT
In this paper, the authors lay out some commonly accepted HCP analytical methods, the challenges of HCP assay, and provide recommendations on what can easily be accomplished in-house and when it may be better to outsource.
Despite pharmacovigilance legislation being in place for nearly a decade, many companies are still struggling to fulfill obligations.
See how stability of a formulation in Woodstock Sterile Solutions’ primary container design compares to glass vials.
Study results indicate that fatty alcohols may plausibly enhance the skin permeation of clotrimazole.
This whitepaper provides an overview of developing a comprehensive contamination control strategy (CCS), taking into consideration the various aspects of pharmaceutical manu
This article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.
Read about how we helped The Clinician increase users to their website by 85%, new users by 92%, and sessions by 94%
Assessing the integrity of filter membranes is critical for maintaining sterile filtration operations in laboratories.
The authors describe a new method for the production of personalised medicines utilising ultra-precise microdrop printing technology.
Innovative drug delivery solutions are evolving due to advances in biotechnology and the demand for biologics, focusing on user-friendly devices that improve patient compliance and support high-viscosity, large-volume treatments and various therapies.
The authors propose an alternative to the USP disintegration test method. The method embraces physiological conditions of the oral cavity, as a screening tool for developing ODT products.
The purpose of this article was to demonstrate the application of a new thermogelling matrix in the healing of wounds.
An ambitious survey of characterization techniques presents current information.
Societal™ CDMO's J. David Enloe and Erica Raether discuss the fundamentals of maintaining a strong company culture during times of change.
Although there have been recent setbacks for China with regard to exported products, the country has made substantial strides in its pharmaceutical industry over the past few years. Intense competition and a series of new regulations seem to be moving the country into a period of recovery.
ROSS Ribbon Blenders meet the toughest standards for quality and long-term performance. Known worldwide for heavy-duty robust construction, high quality materials and fine craftsmanship, these blenders are available in a variety of customizable configurations ranging from laboratory sizes to 1000 cubic feet. We pay close attention to every detail in design and fabrication, a commitment that translates to higher production value for the end user.