Biopharmaceuticals in prefilled syringes complement Boehringer Ingelheim’s contract manufacturing services
At the end of October 2007, Boehringer Ingelheim received FDA approval for the manufacture of a biological drug in prefilled syringes; the European Medicines Agency (EMEA) already granted approval in July 2007. This product has been produced in a lyophilized form, i. e. as freeze-dried powder, by Boehringer Ingelheim as contract manufacturer for the global market since 1998. Now the product will also be available in glass prefilled syringes.
This is the first biopharmaceutically manufactured medication which is offered in prefilled syringes by Boehringer Ingelheim. The approval for filling the drug directly into ready-to-use syringes indicates an adaptation to the growing trend towards liquid and user-friendly biopharmaceuticals; at the same time it also expands Boehringer Ingelheim’s product portfolio in contract manufacturing. In future, more drugs the company’s own products as well as those manufactured for external industrial clients – can be offered in prefilled syringes. The new filling and packaging line has a capacity of 25 million syringes per year.
Boehringer Ingelheim is one of the largest and leading manufacturers of biopharmaceuticals worldwide and provides contract manufacturing services for leading biotechnology companies. Boehringer Ingelheim provides the entire biotechnical process chain in early development and large-scale commercial manufacturing from cell-line development, production including fermentation and protein chemistry, downstream processing and formulation to filling and finishing in state-of-the art application systems as well as global registration and marketing of biopharmaceuticals. The new filling and packaging line for prefilled syringes considerably expands this “One-Stop-Shop”-concept.
Compared to drug administration by means of vials and syringes, prefilled syringes have several advantages, above all the convenience and safety for patients or nurses. Furthermore the risk of administering the wrong drug or giving the wrong dose is significantly reduced.
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