Straight To The Point
In the wide and varied world of pharmaceutical contract manufacturing there is an ongoing debate about what type of company you should look for when you need a contract manufacturing company. Some experts point to the benefits of working with a generalist-type company – a jack of all trades – that can supply a wide array of services. Others point to the benefits of working with companies that are specialists – those that concentrate their efforts and expertise to do one thing and to do that one thing better than anyone else.
When it comes to injectables – that company is OsoBio.
OsoBio's facilities are located in Albuquerque, New Mexico and encompass
administration, manufacturing, inspection, and warehousing functions as well
as a wide array of support services
Indeed, as you drive up to OsoBio’s main facility in Albuquerque, New Mexico its plain to see where their area of concentration and expertise lie, because right on the sign under the company’s name it says it all: Osobio - An Injectables CMO.
The OsoBio Story
As with many CMO and CSO firms today, OsoBio’s road to its present incarnation is a story of past companies, mergers, acquisitions, upgrades and then a concerted focus on providing the best injectables manufacturing service possible.
“We specialize in sterile manufacturing, liquid, liquid suspensions and lyophilized formulations,” says the company’s President, Milton Boyer.
“The business has been here for about 30 years under different names,” says Boyer, “and I think we have commercialized about 250 – 260 products and that spans about every therapeutic category.”
Indeed, the company’s past reads like a who’s who of the pharmaceutical industry. The operation dates back to 1980 when it was built by Summa Medical. It was purchased by Erbamont in 1988 and renamed Adria SP as the primary product that was manufactured was Adriamycin – a sterile product – which started the site’s sterile manufacturing legacy. In 1993 the company was acquired by Pharmacia, which became Pharmacia Upjohn in 1995. In 1997 a management buyout was done and the company was renamed SP Pharma – a clinical scale CMO. In 2001, SP Pharma became a part of Cardinal Health’s PTS division - a large network of CMOs. “The key part about the Cardinal acquisition was that they made sizable investments in the site to bring it to a commercial scale facility,” says Boyer.
A few years later in 2007, Cardinal PTS was spun off becoming Catalent, and the next year a group of private investors bought the site and in May 2008, OsoBio became a reality.
According to Boyer, OsoBio has retained the best parts of the previous owners, helping the company attract big pharmaceutical clients.
“We have returned the company to a nimble entrepreneurial company while still having the best IT systems and quality systems available,” says Boyer.” We use the investments that have been put in.”
Current Capabilities and Facilities
OsoBio’s campus in Albuquerque features four buildings: a manufacturing facility, an administrative building which also houses engineering and maintenance, and metrology and validation functions; a lab building which features a QC area and the company’s IT group and the warehouse and packaging facility which also houses the company’s Sterile University.
OsoBio’s manufacturing facility features two compounding/formulation areas encompassing three Grade A aseptic filling suites with vial filling capacities from 2 cc to 100 cc. There are four lyophilizers with a total of 1230 square feet of capacity. The plant can handle all types of sterile liquids, suspensions and lyophilized formulations aseptically filled and/or terminally sterilized.
OsobBio specializes in sterile manufacturing. Over the years it has
commercialized almost 260 products in virtually every therapeutic category.
"We are set up to do commercial scale production,” says Boyer, “but we can also do clinical scale. Anything from early Phase II to commercial scale products can be accommodated.”
The company can also process potent and cytotoxic compounds. “Using the appropriate assessment tools, we have been able to process SafeBridge 4 and 5 products in a multi-use facility," notes Boyer.
In the packaging, inspection and warehousing facility the company boasts approximately 139,000 square feet of total warehouse space and with 7,000 square feet of 2° – 8° cold storage and 10,000 square feet of ambient storage.. There is also DEA compliant storage available.
In the company’s inspection, labeling and packaging facilities technologies available include 2 semi-automatic and 3 manual inspection stations; two labeling machines, and 3 cartoners.
When asked about the need for multiple inspections of glass vials, Boyer points out that glass quality is a big issue when you are processing injectables. "There are two primary types of vials - molded vials and tubing vials - with molded vials having a generally higher defect rate. We routinely perform a 100% inspection of incoming glass and have seen rejection rates as high as 40%. For high value products, glass quality is a key issue and pre-inspection is a crucial component of the manufacturing process."
Numerous quality control systems and inspection strategies are employed to
ensure the highest quality.
Speaking to the valuable contributions equipment vendors make to the overall success of his company Boyer says, “It is extremely important especially in the design and set up of equipment for factory acceptance – we need their expertise for proper operation of equipment. In many cases we choose the same vendor to have continuity and familiarity with equipment.”
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 it 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.”
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.”
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.
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."