August 1, 2012
Recent advances in the research of therapeutic biologics have resulted in increased market demand for novel manufacturing systems to help meet the growing production need. Recent data resulting from increased research into the human immune system has resulted in the development of innovative treatments for a number of diseases with large unmet need both as vaccination and therapy. To compliment this growth, new approaches in pharmaceutical manufacturing help to fill complex biological products, not only to secure supply, but also to achieve gains in productivity that help create affordable end-user prices. As an internationally recognized leader among contract development and manufacturing organizations (CDMOs) that acts as a strategic partner for the pharmaceutical and biotech industries, Vetter has been addressing these market needs. A newly designed and constructed, innovative, high-speed manufacturing line at its Ravensburg location enables efficient and high-quality filling of up to one million syringes per day, providing a competitive answer to the increased demand.
High Demands
When vaccines are involved, speed and quality are two key decisive factors when it comes to filling not only vaccines but other high-volume products as well. And because innovative biotech drugs are expensive to develop and are frequently sensitive to loss of activity during production, they require a safe production environment that both protects the drug and avoids losses. Drug companies are therefore increasingly searching for solutions that are efficient and that deliver outstanding quality reliably.
Innovation That Results in High Quality
One of the decisive challenges in manufacturing high-volume parenterals with syringes is aseptical tub handling throughout the entire process. To achieve high aseptic reliability, Vetter’s high-speed line incorporates a fully automated process in a spray disinfection tunnel, as well as for the transport and opening of the sealed tubs. This is complemented by an intelligent zone transfer scheme from low cleanroom classes to higher ones. Innovative tub transfer enables a safe and efficient handling process.
Flexibility for Individual Needs
For safety, the high-speed line was designed with a restricted access barrier system (RABS) that allows a product changeover within only a few hours affording high efficiency. The line can process singly or doubly packed tubs. And the system allows filling in several formats. Different pumping systems can be used depending on the substance to be filled (e.g., rotary vane pumps, membrane pumps, and peristaltic pumps).
Full Support
Vetter is a full-service partner for its customers, filling prefilled syringes not only for commercial manufacturing of small- to high-volume products, but also for the early development phase of new drugs. With its extensive know-how in the processing and packaging derived from its long experience with aseptic manufacturing, Vetter offers state-of-the-art technology. This know-how extends to our Vetter Development Service’ locations in Chicago (USA) and Ravensburg (Germany). Support begins during the preclinical phase along with formulation support and choice of primary packaging. Thus, Vetter can handle the drugs it fills from clinical studies through regulatory approval all the way to commercial manufacturing.
About the Author
Author Details
Dr. David Brett is product and service manager at Vetter Pharma International GmbH, Eywiesenstrasse 5, 88212 Ravensburg, Germany, 49-751-3700 0; [email protected].
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