Lilli Zakarija, MSME, MBA, explains that in order to conduct a successful V&V on the intended combination product, the key is to understand that the V&V testing is not an isolated activity and task.
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.
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.
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.
Roger Kurinsky, Senior Vice President of Tubular Glass Americas talks about recent strategy shifts, the importance of the US pharma market, and how Gerresheimer’s investments in the US can benefit pharma companies.
PACKAGING SOLUTIONS – New Deep-Drawn Alufoil Container Solves Crucial Packaging Issues for Vital Pharmaceutical Products
Georg Buchinger and Cora Helberg show how the adoption of aluminum containers for pharmaceutical products is a natural evolution of a technology used by packaging leaders since the 1990s, and an ideal prophylactic measure for the growing needs of demanding pharma customers.
ADVANCED DELIVERY DEVICES – How Data Hubs & Smart Devices Are Enabling the Rise of Therapeutic Ecosystems
Stephen Allan discusses how unique collaborations between tech and biotech reflect a new paradigm in how therapeutics are being commercialized and marketed under the new pay-for-performance healthcare model.
Michael Hooven, CEO of Enable Injections, discusses his vision for the company and how it intends to create marketleading biologics delivery devices that meet the most pressing needs of pharmaceutical companies while enabling easy patient self-administration for significant cost-savings.
Kevin James and Shalini S. Dewan of BCC Research believe eliminating the risk of contamination is the greatest challenge faced by manufacturers of biopharmaceuticals, and currently, this requires high-level monitoring of critical manufacturing processes. Single-use technology aids biopharmaceutical manufacturers in overcoming this challenge by reducing or eliminating the need for sterilization between batches, thereby improving operational efficiency.
Kevin James and Kevin Gainer of BCC Research indicate the development of the market for combination products is closely related to the drug delivery systems sector, which represents a vast area of research and the demand for sophisticated drug delivery devices behind many novel product developments.
EXCLUSIVE ONLINE CONTENT
By 2050, it is projected that the proportion of people aged 65 and older will be more than double that of children aged 5. This global phenomenon is also leading to an increasing number of people suffering from chronic diseases, such as diabetes and osteoporosis.
Enable Injections, Inc., a patient-centric drug delivery combination product company developing advanced wearable devices for subcutaneous delivery of high-volume therapeutics, recently announced it has entered into development agreements with Apellis Pharmaceuticals, and most recently, UCB.
A team of industry experts awarded Nemera’s electronic add-on for ophthalmic droppers with a prestigious CPhI Award for Best Drug Delivery Device in its category.
Aptar Pharma, a leading drug delivery systems provider, continues its commitment to meeting new market trends with the release of an industry first, PureHale, a new portable and ready-to-use drug delivery solution designed for upper respiratory care.
Nevakar Inc. recently announced it entered into an exclusive licensing agreement with Endo International plc’s subsidiary, Endo Ventures Limited, for the development of five differentiated, sterile injectable products in the US and Canada.