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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.
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.
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.
MARKET BRIEF - Preferences for Targeted Therapies & Patient-Centric Approaches Drive Transformations in Oncology Drug Delivery Market
Frost & Sullivan Analyst Piyush Bansal says although chemotherapy has been successfully used for inhibiting cell growth throughout the past few decades, the side effects of chemotherapy have forced researchers to look for some alternative drugs (and how to effectively deliver them) for all types of cancer.
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.
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.
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.
EXECUTIVE INTERVIEW - Oasmia Pharmaceutical: Commercializing Technologies While Pursuing the US Market
Julian Aleksov, Executive Chairman of Oasmia Pharmaceutical, discusses his company’s efforts to enter the US market, its strategy to increase commercial adoption, and why it believes its underlying drug delivery system technology is significant not only within the oncology sector, but the entire pharmaceutical industry.
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.
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.
SPECIAL FEATURE - Formulation Development & Manufacturing - CDMOs Offer Speed, Advanced Technologies, & the Ability to Handle More Potent APIs
Contributor Cindy H. Dubin speaks with some of the industry’s leading CDMOs to highlight their capabilities in the areas of speed, quality, technology, and handling of complex APIs.

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