Contamination-free filling process may speed vaccine manufacturing

12/01/2004

BY STEVE SMITH

STAMFORD, Conn.—A contamination-free filling process for injectables, developed by InTact Filling systems, a subsidiary of Medical Instill Inc. (www.medinstill.com), promises higher safety levels and lower operating costs for pharmaceutical producers.

The glass or plastic vial in the InTact filling system features a proprietary pre-sterilized and re-sealable stopper. The containers are filled with a non-coring needle, then re-sealed for purity with a low-energy laser. Click here to enlarge image

The InTact process is based on a closed filling system, using pre-assembled and sterilized glass or plastic containers that are filled through a stopper by a non-coring and sterile needle. The stopper is then resealed with a low-energy laser to create a pure barrier, eliminating the need to add germ-destroying chemicals.

Click here to enlarge image

Last August, the system achieved third-party performance qualification and microbiological validation, with no microbiological contamination found in three media fills of 10,000 vials each.

Dr. Daniel Py, Sc.D, chairman of MedInstill, says InTact represents "a paradigm shift away from current filling technologies and toward innovative, simple technologies with far-reaching applications beyond pharmaceuticals."

The company says its filling process allows for easier storage, quicker filling, and faster turnaround from storage to syringe. InTact also enables vaccine production in smaller and more mobile situations, and is designed to be faster and less expensive than traditional filling methods.

"One of the factors contributing to the flu vaccine shortage is the inability of companies to guarantee a sterile environment for the injectables," says Dr. Py. "Our process solves this problem by allowing manufacturers to have greater confidence in sterility, turn around new vaccines quickly, and respond to shortages without fear of contamination."

In October, MedInstill granted exclusive rights for the InTact process until 2021 to GlaxoSmithKline Biologicals (GSK-Bio), which intends to use the technology in its pharmaceutical manufacturing and offer it to the rest of the industry through its Belgian subsidiary, Aseptic Technologies.

"This unique, new filling method will provide aseptically processed products with exceptionally high sterility assurance levels through very simple technologies," says GSK-Bio President Jean Stephenne. "It will totally change the way terminally sterilized injectable products are manufactured in the pharmaceutical industry."