Featured Articles From The Current Issue
SPECIAL FEATURE - Prefilled Syringes & Parenteral Contract Manufacturing: Biologics Present a New Set of Challenges
Contributor Cindy H. Dubin speaks with leading syringe developers and contract manufacturers to discuss how they are overcoming industry challenges and provides a look at some of the innovative advancements in prefilled syringe technology.


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Derek Hennecke says once we understand what happens in our brains as we weigh our options, we can extrapolate this knowledge and look with fresh eyes at how CDMOs, large pharma, and the industry make decisions.
Lilli Zakarija, MSME, MBA, cautions that while OTS devices are already “developed” and on the market, they should still go through the device development design control process from the perspective of the combination product, and then let the design control process determine if the device meets the specific requirements of the CP.
Xiaoyi Xu, MS, Chandreyee Das, PhD, and Michael Sturges, PhD, indicate that the phosphorylation of histidine has not been widely studied in mammalian cells, despite its discovery in bovine liver mitochondria, and ask the question, could the phosphorylation of histidine emerge as a therapeutically important pathway in mammals?
T.R. Shantha, MD, PhD, FACA, says the market for new anti-diabetic therapeutic agents and their painless delivery is enormous and is sure drug companies and research scientists are in a race to develop a safer method other than the pulmonary and oral routes to deliver insulin.
Bruce K. Redding, Jr, CEO and Founder of TSI, discusses the importance of developing a new tool for enhanced drug delivery, but also a means to reduce the time-to-market for new formulations while also expanding the number of drugs that can be delivered transdermally.
Enrico Corona, indicates full scalability between laboratory and production lyophilization units allows for the development or optimization of freeze-drying cycle parameters that yield significant cost savings.
John A. Bermingham asks what’s the difference between leadership and management? Or is there one?
Contributor Cindy H. Dubin highlights several CDMOs that are evolving their models to become their clients’ single provider and to accommodate their more potent, challenging products.
Jean Pierre Wery, PhD, indicates immunotherapy in combination with traditional treatments has the potential for becoming a more effective alternative to the current standard of care. These types of combination therapies are currently under investigation and appear to have synergistic effects compared to the use of one therapy alone.
Andrew N. Cleland, PhD, Jean-Luc Fraikin, PhD, Peter Meinhold, PhD, and Franklin Monzon, PhD, describe a new diagnostic instrument able to rapidly and accurately report detailed nanoparticle size distributions for a wide variety of nanoparticle types and concentrations in a range of different solutions.
Noam Emanuel, PhD, reviews how PLEX is a unique local drug delivery platform that brings numerous innovative solutions to the market in various fields, such as infections, inflammations, and cancer.
Frost & Sullivan Analyst Nadim Michel Daher indicates radiology is going through interesting times. Under the coordinated care paradigm that is gradually emerging in the US, as well as all the changes forced on volume-based economic models, medical imaging enterprises are under a great deal of pressure to redefine their goals and reassess their value.
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Ajinomoto Althea, Inc. Announces Issuance of New US Patent for Manufacturing of Crystal Monoclonal AntibodiesAjinomoto Althea, Inc. Announces Issuance of New US Patent for Manufacturing of Crystal Monoclonal Antibodies
Ajinomoto Althea Inc., a leading provider of biotherapeutic contract development and manufacturing services, today announced that the United States Patent and Trademark Office has issued US Patent 9,310,379 covering methods to crystallize monoclonal antibodies for the purpose of scale up and cGMP manufacturing for therapeutic use. The patented methods are important for successful stabilization, storage and delivery of biologically active antibody crystals.

Capsugel Expands Micro-Dosing Services to Help Accelerate Customers' Product Development Timelines Capsugel Expands Micro-Dosing Services to Help Accelerate Customers' Product Development Timelines
Capsugel, a global leader in delivering high-quality, innovative dosage forms and solutions, today announced that it is expanding its micro-dosing services offering for early-phase feasibility work. Capsugel’s offering combines its proprietary Xcelodose® Precision Powder Micro-Dosing Systems with industry-leading powder-in-capsule/powder-in-bottle (PIC/PIB) expertise developed at Xcelience, which Capsugel acquired in January.

Aptar Pharma's Preservative-Free Multi-Dose Ophthalmic Squeeze Dispenser Launched in USAptar Pharma's Preservative-Free Multi-Dose Ophthalmic Squeeze Dispenser Launched in US
Aptar Pharma, a global solution provider of innovative and proven aerosol, injection and spray delivery systems for biotech, healthcare and pharma products, has partnered with a leading eye care company to develop and launch a new eye drop product, which uses Aptar Pharma’s innovative preservative free multi-dose Ophthalmic Squeeze Dispenser (OSD).

Dublin-Based Innopharma Technology Announces Strategic Collaboration With Glatt Dublin-Based Innopharma Technology Announces Strategic Collaboration With Glatt
Dublin-based Innopharma Technology and Glatt (India) Systems Pvt. Ltd. have recently announced a strategic collaboration that is set to reduce product manufacturing costs while increasing compliance and product quality for the pharmaceutical, MedTech, and food industries.

Disease-Modifying Drugs Will Propel Huntington’s Disease Market to $2.6 Billion Disease-Modifying Drugs Will Propel Huntington’s Disease Market to $2.6 Billion
The Huntington’s disease market will rise from around $252.6 million in 2014 to over $2.6 billion in 2024, representing a huge Compound Annual Growth Rate (CAGR) of 25.6%, according to research and consulting firm GlobalData.

Meggle Announces New Head of Sales & MarketingMeggle Announces New Head of Sales & Marketing
The Business Group Excipients & Technology of MEGGLE announced the appointment of Dr. Albrecht Kraemer, as its new Head of Sales & Marketing as of April 1, 2016

Heart Failure Market to Soar to $11.8 Billion by 2025 Heart Failure Market to Soar to $11.8 Billion by 2025
The heart failure market is set to rise from around $3.2 billion in 2015 to $11.8 billion by 2025, representing a compound annual growth rate of 13.7%, according to research and consulting firm GlobalData.

Comparative Human In Vivo Study of an Immediate-Release Tablet Over-Encapsulated by Gelatin & Hydroxypropyl Methyl Cellulose Capsules – Impact of Dissolution Rate on BioequivalenceComparative Human In Vivo Study of an Immediate-Release Tablet Over-Encapsulated by Gelatin & Hydroxypropyl Methyl Cellulose Capsules – Impact of Dissolution Rate on Bioequivalence
Rapid and consistent in-vivo drug dissolution is critical for drug absorption. In-vitro dissolutions tests are used to predict in-vivo disintegration and dissolution properties of drug products...

​INTERPHEX & Industry Experts Select Nemera as Winner for Best New Product ​INTERPHEX & Industry Experts Select Nemera as Winner for Best New Product
International Pharmaceutical Expo (INTERPHEX), the premier event dedicated to pharmaceutical and biotechnology innovation, technology, and knowledge from development through commercialization and sponsored by the Parenteral Drug Association (PDA), has announced the winners for the INTERPHEX Exhibitor Awards for 2016.

First Gene Therapy Claims to be Successful Against Human AgingFirst Gene Therapy Claims to be Successful Against Human Aging
Elizabeth Parrish, CEO of Bioviva USA Inc. has become the first human being to be successfully rejuvenated by gene therapy, after her own company’s experimental therapies reversed 20 years of normal telomere shortening.
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AAPS National Biotechnology Conference
May 16-18
Boston, MA

Cleaning Validation Summit
May 23-24, 2016
Racquet Club of Philadelphia, PA

BIO 2016
June 6-9
San Francisco, CA

PharmaPack
June 14-15
New York, NY

Controlled Release Society Meeting
July 17-20
Seattle, WA

Process Validation Summit
June 27-28, 2016
Racquet Club of Philadelphia, PA

Transdermal Drug Delivery Systems
September 12-13, 2016
Racquet Club of Philadelphia, PA

CPhI Worldwide
October 4-6
Barcelona, Spain

PDA – Universe of Pre-filled Syringes & Injection Devices
October 17-18
Huntington Beach, CA

Pharma Ed's Extractables and Leachables Forum
October 24-25, 2016
Racquet Club of Philadelphia

AAPS Annual Meeting
November 13-17
Denver, CO

 



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