FAQs on What Happens If You Miss the Serialization Deadline
By: Catherine Hanley Serialization affects all stages of the supply chain and with many companies, small and large, unprepared for the scope of regulations…
NANOPARTICLES - A Revolution in the Development of Drug Delivery Vehicles
Tim Leaver explains how his company has developed a proprietary technology for the rapid development of nanoparticles and seamless scale-up for clinical studies and commercial production, and how it is transforming the development and manufacturing of a range of nanoparticle formulations from a hit-and-miss affair to a standardized process, accelerating novel nanomedicines from the bench to the clinic.
SPECIAL FEATURE - Wanted: New Excipients to Meet the Demands of a Challenging Industry
Contributor Cindy H. Dubin recently spoke with some of the leading excipient innovators to find out what types of excipients they are developing, the advantages they offer to formulations, and where they see the industry focusing throughout the next few years.
SPRAY-DRIED DISPERSIONS - Particle Engineering of Spray Dried Dispersions: Considerations for Downstream Processing
Aaron Goodwin, PhD, Alyssa Ekdahl, and Deanna Mudie, PhD, demonstrate the tunability of SDD particle properties and the resulting impact on the powder flow and mechanical properties for tablet manufacturability of a given SDD formulation.
CONTRACT MANUFACTURING - Delivering Market Success & ROI to Pharmaceutical Partners
Mike Schaefers, PhD, and Mike Treadaway say more than ever, contract manufacturing must deliver continuous innovation and flexibility to accommodate the delivery of a wide range of drugs throughout each therapy’s lifecycle.
LYOPHILIZATION - Lyophilization Cycle Development: Lessons Learned & Pitfalls to Avoid
John W. Burke, MS, says that success in lyophilization transfer and scale-up projects depends on a structured approach to information sharing between a pharma company and its CDMO partner, and should include extensive details about the APIs or bulk drug substance characteristics and planned development and clinical programs.
MDI CHARACTERIZATION - Closing the Gap Between In Vitro Test Data & the In-Use Performance for Metered Dose Inhalers
David A. Lewis, PhD, presents experimental data that shows how certain modifications to the Pharmacopoeial test methods used for MDIs may result in data that is more indicative of real-life performance, providing insight that can be used to enhance drug delivery characteristics.
EXECUTIVE INTERVIEW - Pfizer CentreOne: The Value of the Embedded-CMO Model
Peter Stevenson, Vice President and General Manager of Pfizer CentreOne, discusses the value and significance of the embedded-CMO model in the biopharmaceutical industry.
EXCIPIENT UPDATE - Solvent-Less Film Coatings: New Ethylcellulose Grade Enables Rapid Dry Powder Coating
Nick Grasman and Paula Garcia Todd, MS, present ETHOCEL HP as an innovative new product that helps customers increase productivity while still maintaining the advantages of Dow manufactured ETHOCEL, such as tight viscosity, narrow ethoxyl distribution, and reduced fiber content.
THERAPEUTIC FOCUS - A New Patented Device for Treating Obstructive Sleep Apnea & Snoring
Bob Wieden presents a device he believes addresses the underlying anatomic and physiologic etiology of snoring and OSA in a simple but inventive way, and if developed, has the ability to increase patient compliance by reducing the use of CPAP machines, by making a sufferer’s life more comfortable, while preventing many of the contributing diseases.
EXTERNAL DELIVERY - Diary of a Wimpy CEO
John A. Bermingham talks about his experiences working for CEOs with great strength and character, as well as those considered to be “wimps” who had very little respect from the management team.
NEEDLE-FREE INJECTION - Portal PRIME: A Digitally Controlled, Cloud-Integrated Jet Injection System
Patrick Anquetil, PhD, and Gaspar Taroncher-Oldenburg, PhD, report on Portal PRIME, a needle-free and digitally controlled jet injection device that is breaking new ground for injectable drug delivery.
Pion Inc. Acquires Sirius Analytical Instruments Ltd.
Pion Inc., an industry leader in analytical instrumentation for drug development for the pharmaceutical industry, recently announced the acquisition of Sirius Analytical Instruments Ltd., headquartered in…
Pion Inc. Acquires Sirius Analytical Instruments Ltd.
Pion Inc., an industry leader in analytical instrumentation for drug development for the pharmaceutical industry, recently announced the acquisition of Sirius Analytical Instruments Ltd., headquartered in…
Pion Inc. Acquires Sirius Analytical Instruments Ltd.
Pion Inc., an industry leader in analytical instrumentation for drug development for the pharmaceutical industry, recently announced the acquisition of Sirius Analytical Instruments Ltd., headquartered in…
Pion Inc. Acquires Sirius Analytical Instruments Ltd.
Pion Inc., an industry leader in analytical instrumentation for drug development for the pharmaceutical industry, recently announced the acquisition of Sirius Analytical Instruments Ltd., headquartered in…
Pion Inc. Acquires Sirius Analytical Instruments Ltd.
Pion Inc., an industry leader in analytical instrumentation for drug development for the pharmaceutical industry, recently announced the acquisition of Sirius Analytical Instruments Ltd., headquartered in…
SPECIAL FEATURE - Prefilled Syringes & Parenteral Manufacturing: A Rise in Biologics & Improved Technology Give Pharma Reasons to Consider Parenteral Delivery
Contributor Cindy H. Dubin speaks with some of the leading companies in this market to find out about key trends, packaging advancements, safety improvements, and technology developments.
CONTROLLED RELEASE - Leveraging Precision Particle Fabrication® Technology to Create Patient-Friendly Dosage Forms
Cory Berkland, PhD, and Nathan Dormer, PhD, review how controlled-release powders offer a flexible and efficient approach to addressing a multitude of patient populations, while also improving compliance.
GALECTIN-DIRECTED THERAPIES - Targeting Galectin-3 Protein in Drug Development
Peter G. Traber, MD, believes we are only at the beginning of understanding the full potential of gal-3 targeted therapy, and the future likely holds additional high affinity, specific, galectin inhibitors that are bioavailable by routes other than the two currently in development.
