issues

May 2015

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COVER

SPECIAL FEATURE – Prefilled Syringes & Parenteral Contract Manufacturing: Anticipating the Needs of the Future

Contributor Cindy H. Dubin speaks with several companies in the prefilled syringe and parenteral manufacturing market that are offering a range of services and systems that cater to today’s issues as well as anticipating the needs of the future.

FEATURES

SPECIAL FEATURE – Prefilled Syringes & Parenteral Contract Manufacturing: Anticipating the Needs of the Future

Contributor Cindy H. Dubin speaks with several companies in the prefilled syringe and parenteral manufacturing market that are offering a range of services and systems that cater to today’s issues as well as anticipating the needs of the future.

THE SECOND QUADRANT – The Birth of Physical Pharma: 1920-1960

Marshall Crew, PhD, observes progress that enabled spray drying for pharmaceutical applications, as well as other progress that has enabled the solubilization technologies and approaches we use today.

ADVANCED DELIVERY DEVICES – Design & Evaluation of a Polymer-Based Prefillable Syringe for Biopharmaceuticals With Improved Functionality & Performance

Sagarika Bose, PhD, and Kevin Constable address the design of a new commercially available polymer-based prefillable syringe with enhanced performance features when combined with complex biopharmaceutical drug products.

BIOTHERAPEUTICS DEVELOPMENT – The Role of Flow Electroporation in Vaccine Development

James Brady, PhD, Karen Donato, PhD, and Krista Steger, PhD, indicate that with unmatched quality, flexibility, and scalability, flow electroporation is a universal, cost-effective platform that supports the full range of biotherapeutic and vaccine development activities.

PATIENT SAFETY NARRATIVES – Clinical Trials: Medical Writing & Patient Safety Narratives

Yvonne Moores believes patient safety narratives are a key element in clinical study reporting and reviews current regulatory requirements regarding safety narratives, a proposed process for their development, and ways to simplify the reporting process.

EXECUTIVE INTERVIEW – SOLIZE: 3D Data-Based Engineering & Manufacturing to Accelerate Delivery Device Development

Yoshiki Matsuda, Director of SOLIZE, discusses how his company can create new and innovative solutions to accelerate the development of devices and combination products built thereon.

EXECUTIVE INTERVIEW – Gerresheimer: Plastic Perfection

Niels Düring discusses Gerresheimer’s Plastic Packaging division and the complementary synergies working for a company that also manufactures glass provides.

THERAPEUTIC FOCUS – Adenosine Receptors – The Promise of A3AR Research

Pnina Fishman, PhD, reports that the A3AR adenosine receptor, expressed in the lungs, liver, brain, aorta, testis, and heart, may hold promise as both a therapeutic target and as a biological predictive marker.

EXTERNAL DELIVERY – Fight the Good Fight

John A. Bermingham says all of us have experienced situations in which we feel strongly about an issue or project and are prepared to “fight” for what we so strongly believe in. Courage is mandatory in these circumstances; however, courage alone is not the only necessity.

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