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.
Lisa A. Dick, PhD, describes how microneedle technology is being applied in two new transdermal systems using solid and hollow microneedles, which have the ability to deliver small molecules as well as biologics, opening up the potential for self-administration of a broad array of APIs
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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.
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.
Credence MedSystems Closes $12.8-Million Financing to Support Ongoing Development & Scaling of Innovative Delivery Products
Credence MedSystems, Inc., an innovator in injectable drug delivery devices, recently announced the closing of a Series B financing resulting in gross proceeds to the company of $12.8 million.
As we come to learn more about the human body, the dynamics of the industry must react accordingly. A primary example of this is the fact that the dominating blockbuster drug model that was paramount in the industry until a couple of years ago is no longer valid……