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.
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.
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.
Niels Düring discusses Gerresheimer’s Plastic Packaging division and the complementary synergies working for a company that also manufactures glass provides.
ADVANCED DELIVERY DEVICES – Self-Administration Device Training: Incorporating New Technologies to Reduce Device Errors
Craig Baker says at its core, the ultimate goal of device training is to improve the patient experience and create value for HCPs and industry stakeholders, and improved training technologies can allow brands to engage patients and provide personalized training content based on individual patient needs and performance.
Richard Featherstone explains how manufacturers of combination products are being asked to provide rigorous data on the safety of product when intended users use them. These challenges are not going to diminish, but with a focused approach and some sound HF principles, manufacturers can navigate the challenges successfully.
ADVANCED DELIVERY DEVICES – Innovation Without Change: What is it & What Can it Mean for Pharmaceutical Manufacturers?
John A. Merhige, MEM, and Dan Thayer believe a rigorous, risky development and regulatory process forces pharmaceutical manufacturers into a bad compromise between advances in delivery systems and the time, cost, and risk associated with those advances.
Kevin James, Jackson Highsmith, and Paul Evers report the global market for nanoparticles in the life sciences is estimated at over $29.6 billion for 2014. This market is forecast to grow to more than $79.8 billion by 2019, to register a healthy compound annual growth rate of 22%. The biggest increase will come in the area of drug delivery systems.
Evan Goulet, PhD, and Elizabeth Robbins report on the Noxilizer RTS 360 Industrial NO2 Sterilizer that provides surface sterilization of prefilled syringes with a range of material compatibility and low levels of residuals using its rapid, room-temperature process.
ADVANCED DELIVERY DEVICES – Getting It Right: The Importance of End-User Research in the Design of a New Drug Delivery System
Chris Evans believes that designing a drug delivery system that will truly resonate with patients requires insight into the unique experiences of those users by conducting research that will drive innovation in the design and development process to create a solution that works in a variety of situations.
EXCLUSIVE ONLINE CONTENT
Amphastar Pharmaceuticals, Inc. recently announced the US FDA granted approval of its Abbreviated New Drug Application (ANDA) for Enoxaparin Sodium Injection 300 mg/3 mL (100 mg/mL) Multiple Dose Vial (MDV).
Aptar Pharma recently announce that its Bidose nasal spray device was recently approved by the US FDA for a breakthrough therapy in the field of depression.
For pharma and biotech companies both large and small, the challenges involved in the fill and finish process of drugs for clinical development and scale-up continue to present new challenges.
Nemera’s Preservative-Free Multidose Eye Dropper Approved for Santen’s Drug in 29 European Countries
Nemera recently announce its multidose eye dropper Novelia has been approved for the preservative-free formulation Cosopt iMulti (20 mg/ml dorzolamide + 5 mg/ml timolol eye drops, solution).
West recently announced it has commenced discussions with two companies regarding the use of West’s proprietary SmartDose drug delivery platform for complex molecules.