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
Manufacturing Process Scale-Up for Phase III: Clear Sailing or Storms Ahead?Manufacturing Process Scale-Up for Phase III: Clear Sailing or Storms Ahead?
Download this whitepaper to learn how building scalability into formulation throughout drug development, as well as transferring the project to a knowledgeable CDMO in Phase III, can help mitigate some of the challenges that arise in Phase III.

WuXi AppTec Immunotherapy Report: Biotech Sector Will Drive Biggest Advancements in Decades on Cancer TreatmentsWuXi AppTec Immunotherapy Report: Biotech Sector Will Drive Biggest Advancements in Decades on Cancer Treatments
WuXi AppTec – ­­the leading global pharmaceutical and biopharmaceutical open access capability platform – has published a new report on the prospects of immunotherapy treatments, and identified smaller, nimble biotechs, and early stage companies as the single biggest factor behind the next generation of approaches in development.

Biological Bypass Shows Promise in Coronary Artery DiseaseBiological Bypass Shows Promise in Coronary Artery Disease
A new gene therapy that targets the heart and requires only one treatment session has been found safe for patients with coronary artery disease, according to a successful trial carried out in Finland. Enhancing circulation in the oxygen-deficient heart muscle, the effects were visible even 1 year after the treatment.

UPM Pharmaceuticals Successfully Serializes Its First Pharmaceutical ProductUPM Pharmaceuticals Successfully Serializes Its First Pharmaceutical Product
UPM Pharmaceuticals successfully serialized their first product in May of this year. UPM anticipates having all of their clients' products serialized by November 2017. In accordance with the Drug Supply Chain Security Act which had mandated that pharmaceutical manufacturers serialize all pharmaceutical products starting in November 2017, UPM is excited to be ahead of schedule.

Pfizer Partners With Catalent for Exclusive Long-Term Supply AgreementPfizer Partners With Catalent for Exclusive Long-Term Supply Agreement
Catalent Pharma Solutions recently announced that following a successful 20-year collaboration on the development and manufacture of Advil® Liqui-Gels® (ibuprofen), it has entered into an exclusive long-term supply agreement to produce the next generation of Pfizer Inc.’s leading OTC)pain relief product.

Daiichi Sankyo, Max Planck Innovation and Lead Discovery Center Announce Cancer Research CollaborationDaiichi Sankyo, Max Planck Innovation and Lead Discovery Center Announce Cancer Research Collaboration
Daiichi Sankyo Co., Limited (hereafter, Daiichi Sankyo), Max Planck Innovation GmbH and the Lead Discovery Center GmbH have signed an agreement providing Daiichi Sankyo with the option to receive the exclusive rights to a new lead compound for the treatment of cancer to be discovered and developed at the Lead Discovery Center.

Lonza Completes Acquisition of Capsugel, Creating Leading Integrated Solutions ProviderLonza Completes Acquisition of Capsugel, Creating Leading Integrated Solutions Provider
Lonza announced that following the receipt of all required regulatory approvals, it has completed the acquisition of Capsugel S.A. from KKR for $5.5 billion in cash, including refinancing of existing Capsugel debt of approximately $2 billion.

Enable Injections Introduces First Multi-Vial/Multi-Syringe Biologics Delivery System Enable Injections Introduces First Multi-Vial/Multi-Syringe Biologics Delivery System
Enable Injections, Inc., the developer of advanced large-volume wearable injectors (LVWI) for subcutaneous delivery of biologics and high-volume drugs, recently announced a new single-, partial-, or multi-vial/syringe transfer system for filling its LVWIs.

Microneedles - A Novel Alternative in Selected Drug Delivery AreasMicroneedles - A Novel Alternative in Selected Drug Delivery Areas
Microneedles are a novel drug delivery technology that can offer promising advantages as an alternative to classical needle injections and other routes of administration. Therefore Vetter, global provider of aseptic prefilled drug delivery systems and Microdermics, a medical device company developing a novel hollow, metal microneedle drug and vaccine delivery system, have entered into a strategic cooperation.

CordenPharma & GE Healthcare Offer Unique End-to-End Solution to Accelerate Oligonucleotide Drug Development CordenPharma & GE Healthcare Offer Unique End-to-End Solution to Accelerate Oligonucleotide Drug Development
CordenPharma International and GE Healthcare’s Dharmacon business have entered a strategic collaboration to create an end-to-end solution for oligonucleotide-based drug discovery.
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