Time to market for new drugs, and continuing success on the market (Claudia Roth, Vetter)
International pharmaceutical market developments, characterized by growing competition and new technology, are a crucial factor for decisions concerning primary packaging and drug delivery for injectables. Dr. Claudia Roth, Vetter Pharma-Fertigung GmbH & Co. KG, describes decisive factors for shortening new drugs? time to market, and their continuing market success.
Besides a typical developmental overview and role of project management, she describes state-of-the-art application systems as essential active lifecycle management components. She also provides a helpful summary for pharmaceutical companies in a primary packaging launch situation.
Glass containers are the primary packaging of choice for drugs and vaccines in the U.S. and European pharmaceutical markets. Although vials continue to be the most popular container, cartridges and syringes, which are typically used in prefill applications, are growing most rapidly.
This is due to the inherent benefits of prefills for the end-user; most importantly for the convenience and ease of use and for the marketing objectives of pharmaceutical companies to differentiate their products through packaging and delivery systems. Quality requirements for primary packaging are steadily increasing.
The partnership with the supplier of the primary packaging plays a central role for the pharmaceutical company to ensure high quality levels.
For the containers themselves, a very high level of controls (flange, self-adjusting, tip control, inspection systems) is needed to meet dimensional, cosmetic and mechanical criteria.
Regulatory support by the container manufacturer is also very important for the pharmaceutical company to bring their drugs or vaccines to market, especially in a timely manner. Conforming to USP, EP and JP are critical as are providing access to DMFs (U.S) or Technical Files (Europe).
Developing new self-injection devices by keeping the patient in focus (Ralf Kuenzi, Ypsomed)
The main rationale for pharmaceutical and biotech companies to invest in self-injection devices for their injectables is to provide maximum ease of use and safety for the patient.
When developing a device for a specific drug and therapy patient's needs must thus be part of the development process right from the start.
This starts by clearly understanding the particular needs of the respective patient population and must be followed by continuously verifying during the product development process that the device actually meets these needs.
As time-to-market is crucial for success, Ypsomed takes innovation and product development off the critical path of the customers project plans by offering a variety of flexible pen and auto-injector platform technologies.
Ulrich Steuerer is talking about one of the big issues in the US and european Hospitals, regarding patient safety. In the rush of every Hospital today, we find many critical situations wich could lead to medical errors. How can we prevent or reduce this problems?
Syringe Processing and Machinery (Hans Thomas, Bausch & Stroebel)
Bausch + Stroebel, one of the world's leading manufacturers of pharmaceutical equipment, will now present you their latest developments from the 'syringe processing' sector!
Today's principal topic will be the processing of syringes in bulk. Already cleaned and inserted in trays, the syringes are removed from the trays, washed, sterilized, filled, sealed and inserted into trays again on Bausch + Stroebel machines.
The Sales and Marketing Director from Bausch + Stroebel, Mr Hans Thomas will explain the individual working steps from the unpacking through to the reinsertion of the syringes in detail now.
The market trend has been to integrate delivery system earlier in the drug development process. They are no longer an afterthought, but are now integrated into the drug product as a method for addressing unique customer needs and/or extending the life cycle for established drugs.
These systems include pre-filled syringes (with and without needle safety), disposable and reusable pens, and prefilled nasal and oral delivery systems, among others.
These "Combination Products" pose challenges to the manufacturers and the regolatory agencies as to how to regulate the product. This includes determining what information is required during development, manufactoring and post marketing support. This talk will briefly outline some of the issue and practical solutions.