Featured Articles From The Current Issue
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.


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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.
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.
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.
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.
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.
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.
Peter Stevenson, Vice President and General Manager of Pfizer CentreOne, discusses the value and significance of the embedded-CMO model in the biopharmaceutical industry.
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.
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.
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.
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.
Exclusive Online Content
West Highlights Rigid Needle Shields for Prefilled Syringes West Highlights Rigid Needle Shields for Prefilled Syringes
West Pharmaceutical Services, Inc., a global leader in innovative solutions for injectable drug administration, provided more information on its product offering, the Rigid Needle Shield (RNS), at the Parenteral Drug Association (PDA) Europe Annual Meeting.

Q BioMed Finalizes License Agreement for Novel Liver Cancer TreatmentQ BioMed Finalizes License Agreement for Novel Liver Cancer Treatment
Q BioMed Inc recently announce their entry into a final license agreement with The Oklahoma Medical Research Foundation (OMRF) and the Rajiv Gandhi Centre for Biotechnology (RGCB) for the global exclusive rights to develop and market a novel chemotherapeutic drug to treat liver cancer.

COPD Market Set to Hit $14.1 Billion by 2025COPD Market Set to Hit $14.1 Billion by 2025
The chronic obstructive pulmonary disease (COPD) space across the eight major markets of the US, France, Germany, Italy, Spain, the UK, Japan, and Australia, is set to rise from $9.9 billion in 2015 to around $14.1 billion by 2025, representing a compound annual growth rate of 3.7%, according to research and consulting firm GlobalData.

IntelGenx Receives Patent for Topical Oral Film TechnologyIntelGenx Receives Patent for Topical Oral Film Technology
IntelGenx Corp. recently announced that the United States Patent and Trademark Office has issued US Patent 9,668,970 covering the design and manufacturing of topical oral films (TOF) for the local (topical) treatment of diseases of the oral mucosa using mucoadhesive particles.

Lubrizol Invests $60 Million to Expand Particle Sciences, Vesta & Other FacilitiesLubrizol Invests $60 Million to Expand Particle Sciences, Vesta & Other Facilities
The Lubrizol Corporation recently announced its LifeSciences business continues to invest in its key capabilities through a variety of planned expansions. During this latest phase, a $60-million investment will focus on new product solutions, capacity expansion, and additional cGMP manufacturing.

FAQs on What Happens If You Miss the Serialization DeadlineFAQs on What Happens If You Miss the Serialization Deadline
Serialization affects all stages of the supply chain and with many companies, small and large, unprepared for the scope of regulations and data support required it leads to the question: what happens if you miss the serialization deadline?

Acasti Pharma & CordenPharma Announce Large-Scale Production of CaPre With Continuous Manufacturing Acasti Pharma & CordenPharma Announce Large-Scale Production of CaPre With Continuous Manufacturing
Acasti Pharma Inc. recently announced the achievement of a major corporate milestone by manufacturing the first cGMP batches of CaPre®, Acasti’s omega-3 pharmaceutical product candidate, produced with a proprietary and innovative continuous manufacturing process developed in partnership with CordenPharma.

Vetter & Microdermics Enter Into Strategic Agreement to Develop Innovative Microneedle Drug Delivery SystemsVetter & Microdermics Enter Into Strategic Agreement to Develop Innovative Microneedle Drug Delivery Systems
Vetter, a leading and innovative provider of aseptic prefilled drug delivery systems and Microdermics Inc., a Vancouver-based medical device company developing a novel hollow, metal microneedle drug and vaccine delivery system, recently announced that they have entered into a strategic cooperation agreement.

Pion Inc. Acquires Sirius Analytical Instruments Ltd. 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 East Sussex, United Kingdom.

Hovione Announces Start of Phase 1 Clinical Trial Hovione Announces Start of Phase 1 Clinical Trial
Hovione will soon initiate recruitment for its Phase 1 clinical trial of HY02, a proprietary minocycline sterile ointment to treat a subset of ocular surface inflammation, generally manifesting on the inner edge of the eyelids, leading to eye irritation and sometimes more severe symptoms such as blurring of the vision and/or irritation of the cornea.
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