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Straight to the Point, Part 2

Mon, 11/05/2012 - 12:25pm
MIKE AUERBACH, Editor in Chief, Pharmaceutical Processing

This is part two of a two-part piece. Part one can be found here.

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Continuous Improvements

To stay competitive in the contract manufacturing field you need to constantly look ahead and improve the services you offer. OsoBio has recognized this and is in the process of making some noteworthy additions to its state-of-the-art operations.

For example the company has recently installed a new, flexible, oxygen reduction system on all filling lines which allows the company to apply any combination of vial and stopper.

But perhaps the crown jewel in the company’s latest investments is a new Grade A aseptic filling suite for liquid, suspension and lyophilized products.

The rolling diaphragm pump filling suite, manufactured by Bosch, comes equipped with optional rotary piston and peristaltic pumps. It will function at 115 percent of the previous line’s capacity, increasing the speed and efficiency with which OsoBio can deliver drug products to clients.

Thanks to its ability to conduct non-destructive online weight tests, the new line will deliver greater precision and yield. And its restricted access barrier system will minimize risk of cross-contamination and diminish potential occupational exposure.

“This state-of-the-art filling suite represents a substantial investment in the future — the future of OsoBio, as well as the futures of the pharmaceutical clients we serve,” says Boyer. “It allows OsoBio to manufacture drugs in a better, smarter and faster manner, while ensuring high-quality product and the safety of patients and employees alike. This is an exciting new addition to OsoBio’s facility.”

Project Management

State-of-the-art equipment and facilities are essential for any contract manufacturer, but a key piece of the puzzle is project management. OsoBio has implemented an operational excellence strategy that includes the use of lean and six sigma green and black belts throughout their organization to eliminate problems and ensure the highest quality product. This approach has manifested itself in the company’s approach to project management. “We assign a project manager to the each client and they stay with that client,” says Boyer. “The project manager oversees a team here that covers all areas of the project: timelines, budgets, scope, regulatory strategy, purchasing equipment, etc. Those teams meet with the client on a weekly basis until the product is commercialized. Clients appreciate our lean/six sigma programs. It can be a differentiator between us and other companies.”

According to Boyer, quality is the most important defining issue when potential clients are looking at the company. “Companies want to know what your quality record is. They want to know if there any issues that could cause a hold up.”

Higher Education

With quality systems and programs in place, OsoBio has added another wrinkle to its operations that truly set it apart from other CMOs — Sterile University.

Sterile University is a new employee training program the company set up a few years ago to increase quality and drive down costs.

Inside Sterile University OsoBio has set up fully functioning equipment such as a filler and a lyophilizer to enable new employees to get hands-on experience working with the equipment before they go into the sterile “core” of the manufacturing areas.

The filler in the training area was once on the plant floor and can be set-up, broken down and - using colored water as the fill medium — provide specific hands on training without exposing the sterile core to untrained operators. New employees are taught all the features of the fillers and work with all of the components that go into vial manufacturing.

Over at the training lyophilizer, employees learn the ins and outs of traying, using thermocouples and how to load and unload trays.

Employees are also taught how to sanitize floors and walls. A compounding training room is also available for working with formulations, filling tanks, etc. In addition, a wash/prep area is used to train employees how to put pumps and reservoirs together, how to load stoppers, palletizing operations, labeling, and other functions.

Perhaps the most important training done in Sterile University is proper gowning procedures. In this area of Sterile University operators are taught the difference between black, gray and white areas; and the very specific gowning order to ensure sterility.

Boyer explains the value of Sterile University to the company, “If we put an untrained person in the “core” — we would have to do a media fill because that would be considered a “new” event. A media fill is necessary because we need to find out if any “bugs” might grow. By training people we have to do fewer media fills to prove sterility. Media fills are expensive because the equipment is running but we are not producing product. If we can reduce the need for media fills with better training it is of immense benefit to us.” Boyer also points out that better trained operators produce higher quality product — a boon to OsoBio’s customers.

Looking Forward

With its facilities in Abluquerque, OsoBio has created an injectables manufacturer that has specialized expertise and experience to handle the most unique and complex projects. As for the future of the company Boyer says "OsoBio is building an injectable drug contract manufacturing organization that distinguishes itself with world-class customer care, project management and regulatory compliance. By continuing to develop strategic customer relationships and to increase OsoBio's visibility within our industry, I am confident we will achieve the ambitious goals we've set for ourselves."

For more information, please visit www.osobio.com  

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