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 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.
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.
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
Samuel D. Trohman, MBA, Joey L. Glassco, Elena Draganoiu, PhD, and Carey Boyum present developmental and commercial examples of non-biodegradable drug-eluting devices, along with the versatile properties of thermoplastic polyurethanes for the development of effective drug delivery systems.
Degenhard Marx, PhD, and Matthias Birkhoff, discuss how the use of preservatives in eye drops is still controversial, but more and more evidence supports the use of unpreserved eye drops for treatment of chronic diseases.
EXECUTIVE INTERVIEW – Vetter: Helping Small Biotech Companies Execute a Successful Drug Development Process
Dr. Susanne Resatz, President of Vetter Development Services USA, Inc., discusses the many benefits to small biotech companies in utilizing a full-service CDMO, and what advanced services the Chicago-based facility offers its growing customer base.
SYRINGE SYSTEM – The Credence Companion Syringe System Delivers on Safety & Usability Using Human Factors Studies
John A. Merhige, MEM, and Lisa Caparra, RN, explain how development of the Companion product line has been driven by these two constituents, the innovation driven by the end-users’ needs and the avoidance of change driven by needs of the drug manufacturer.
EXECUTIVE INTERVIEW – Terumo: Innovating at the Speed of Life for Cutting-Edge Solutions in Medical Devices & Services
Mr. Juichi “Jim” Takeuchi, Terumo Corporation’s Executive Officer and President of Global Pharmaceutical Solutions, discusses his company’s innovative approach to parenteral drug delivery using integrated science and technology.
Bernd Zeiss provides study results that contribute to a clearer picture of the factors of influence that are crucial to syringe function. Several common hypotheses were verified, while others were refuted.
EXCLUSIVE ONLINE CONTENT
Hovione Technology, a specialist in development of innovative inhalation device technology, recently announced it has secured global rights to develop and commercialize a new ultra-affordable, multi-use blister-based dry powder inhaler patented by inventor Dr. Klaus-Dieter Beller.
Peter Soelkner says there will always be a wide variety of trends influencing our industry and we see no reason why this will not continue well into the future.
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.