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.
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.
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…
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…
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.
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.
EXTERNAL DELIVERY - Fake News
John A. Bermingham says with all the fake news today’s media expels at an alarming rate, CEOs should have a plan in place should it one day raise its ugly head in their company.
CLINICAL RESEARCH - Behind the Wave: Clinical Research in a Digital Transformation Era
Kai Langel believes the remote research model and purpose-built technology offer the tools and the right process to help modernize clinical research and bring it closer to the high standard set by today’s consumer technologies.
ASSAY VALIDATION - Biomarker Assay Validations – A Time for Change?
John L. Allinson, FIBMS, believes despite the increased use of biomarkers, it appears that many researchers are still continuing to use the FDA guidance document for validation even though it only critically addresses the validation of assays to support PK evaluation, and also has a limited scope described within the document in terms of studies where it should be used.
NON-CANNABIS THERAPY - Cannabinoid Therapy Without Using Cannabis: Direct Effects™ Topical β-Caryophyllene
Ronald Aung-Din, MD, in view of many documented medical benefits of cannabinoids, but with widely persisting regulations, misinformation, and stigma associated with cannabis, searches for a non-cannabis-derived source of cannabinoid therapy, such as found in β-Caryophyllene.
EXECUTIVE INTERVIEW - PCT: Manufacturing the Future of Cell Therapies
Robert A. Preti, PhD, discusses his company’s critical distinction from most other manufacturing partners, steady growth, and the primary challenges facing the cell therapy industry.
