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JPM CBRN Medical Teams with Janssen Vaccines & Prevention B.V.
November 25th 2019The Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense’s (JPEO-CBRND) Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) entered into a Letter of Agreement for Materials and Information Transfer with Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical companies of Johnson & Johnson on October 2, 2019. The Agreement defines assay validation submission protocol and reporting processes to the European Medicines Agency, and potentially other foreign regulatory agencies and authorities, to expedite its review of Janssen’s vaccine. The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), a component of the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND), aims to provide U.S. military forces and the nation with safe, effective, and innovative medical solutions to counter chemi
The Pharma Trends You Need to Know – A CDMO’S Perspective
November 22nd 2019The market momentum of novel therapies targeting unmet needs is creating a new landscape for pharmaceutical drug manufacturers. As the focus on these smaller patient pools grows, so does the complexity of drug development. Companies must understand how the molecules filling today’s pipeline are changing our business, as they are causing a dramatic shift in how we plan for and execute drug development and manufacturing.
Finding Fakes – using Raman imaging to identify counterfeit medicines
November 20th 2019Identifying counterfeit drugs has become an area of increasing focus for regulatory authorities and also for pharmaceutical companies. Raman spectroscopy is highly specific and can differentiate between materials with similar chemical structures.
Is Your In-House Strategy Ready For The Uncertainties Of Biologic Drug Development?
October 28th 2019The pharmaceutical industry’s past reliance on blockbuster drugs has evolved to include developing drugs that treat the needs of smaller patient populations. These drugs most often come in the form of biologics, which are an increasingly larger share of new drug approvals in the past decade, from 10 percent to 27 percent.
Six API Challenges That Could be Slowing Your Development
October 28th 2019The challenges for new drugs looking to enter the market are numerous. But many are self-inflicted – especially in small molecule development. A dangerous perception persists that aside from highly potent APIs, small molecule medications have simple process requirements. The reality, however, is that most APIs will require numerous steps or significant work upfront to avoid development delays, rework or outright failure.
Monitoring of transdermal drug delivery in skin using the Renishaw Biological Analyser
October 23rd 2019Detecting the presence and depth of penetration of drug compounds in skin can prove challenging, current technologies fail to achieve adequate penetration through layers of dermal tissue. In this study, Raman spectroscopy using the Renishaw Biological Analyser - RA816 confirmed the presence of a topical compound in the epidermis and reticular dermis with high specificity and sensitivity.
GMP Testing of Raw Materials Through Containers using Spatially Offset Raman Spectroscopy
October 19th 2019This article describes how a Japanese pharmaceutical company successfully implemented the Agilent RapID Raman system for GMP raw material testing through unopened brown paper sacks, and other opaque containers.
Spray drying for enhancing the solubility of poorly soluble drugs
October 19th 2019Spray drying continues to gain importance as a preferred manufacturing technology for amorphous solid dispersions (ASD). A fast carrier selection allows for a more targeted development process with reduced time to market. EUDRAGIT® polymers have not only been proven to be superior with respect to ASD formations but can also stabilize the amorphous state of the API over storage.
The Essential Guide: Cleanrooms and Clean Areas
October 17th 2019At Rite-Hite, we have many solutions for the pharmaceutical industry along with the knowledge and experience to help you address the issues you face with your clean areas. We keep up-to-date on best practices, new design and technology, and the latest trends in the industry.
