Sharp Packaging Solutions (sharpservices.com) has increased its packaging capacity by 30% for its life science customers with a $45 million investment in a new Center of Excellence for specialty/biologic/cold chain packaging on Penn Am Drive in Allentown, PA, and in the addition of four new bottling lines within its adjacent 270,000-square-foot contract packaging facilities at 7451 and 7529 Keebler Way. The Center of Excellence marks Sharp’s third expansion within the Allentown campus since 2014. The contract packaging building at 7529 Keebler Way opened in 2014 and houses six packaging suites, and a technical warehouse and office suite facility opened in 2014 at 7350 William Avenue.

Sharp seized the opportunity to purchase the 112,000-square-foot Penn Am Drive building in 2014, and began interior demolition and construction to offer a state-of-the-art biologic and specialty product packaging operation, complete with comprehensive cold chain and serialization capabilities. After internal construction was completed earlier this year, Sharp moved the company’s existing specialty and biologic packaging lines from its Keebler Way plant to the new Center. It then installed 2 to 8° C cold storage to house 600 pallets, doubling its total refrigeration capacity, and invested in additional packaging and serialization equipment. The investment in this new facility substantially increases Sharp’s ability to handle specialty packaging requirements, with room to increase capacity for these products an additional 30%. Qualification and commissioning of the Center of Excellence was completed in April 2016, and Sharp commenced commercial packaging activities in June.

By consolidating all its specialty and biologic equipment in the new Center of Excellence, Sharp will open up additional packaging capacity for bottling at its Keebler Way facility by September 2016. All bottling lines will be serialization ready, as well as all lines in the Center of Excellence, well in advance of industry requirements for meeting track and trace regulations by 2017. An industry pioneer in serialization, Sharp has been providing serialization services to clients since 2008, with over two billion units serialized in six different formats for 35 client programs, from bottle and individual blister to pallets in support of seven international programs. With the addition of the new capabilities at the Center of Excellence, Sharp will be offering serialization at five of its packaging sites, with the intention of adding 4-5 lines per quarter through 2017.

Sharp’s decision to make this investment at its Allentown campus was fueled by the increasing industry demand for contract packaging services of bottled and blister-packed pharmaceutical products business, coupled with the explosive growth of specialty product and biologic package outsourcing. According to Doug Hill, senior vice president and general manager of Sharp Packaging Solutions. “Customers with specialty drugs and biologics require complex equipment,” Hill notes. “We have customers with vials that need labeling and serialization, syringes with a label pack-out, oral thin film strips and then those with automatic, self-injected devices requiring special assembly. With our new facility, we have the dedicated space to meet the most demanding requirements.”

Due to the proximity of the new building to Sharp’s current packaging facility with the use of the same management team, processes and procedures, the FDA is considering a campus approach in their evaluation of Sharp. A new registration with the FDA will not be required for the Penn Drive Center of Excellence. “We are working very closely with the FDA,” states Hill. “Their only request so far has been to be advised on when we anticipate the first production for the building. That information will be provided and the Agency will then determine if they will review the building at that time or as part of our next GMP Inspection anticipated in late 2016 or early 2017.”