Sharp Packaging Solutions continues to expand its contract packaging operations in Allentown, PA—this time creating a new Center of Excellence for specialty/biologic/cold chain packaging and adding four new bottling lines within its existing adjacent contract packaging facilities. The $45 million investment brings its entire Allentown campus to five buildings, increasing its capacity for pharmaceutical companies by 30% and readying itself for serialization scale up.

Sharp is concentrating specialty/biologic packaging as well as cold chain products at the Biotechnology Center of Excellence on Penn Drive and “devoting everything needed to help the life sciences industry deliver these products in packages for consumers that meet track and trace requirements,” a company representative tells PMP News. The company also maintains Centers of Excellence for bottle, blister, and specialty packaging. All locations provide serialization services.

Sharp relocated its existing specialty and biologic packaging lines from its Keebler Way plant in Allentown to the new center. It installed 2 to 8° Celsius cold storage for 600 pallets to double total refrigeration capacity and also added additional packaging and serialization equipment. Qualification and commissioning of the Center of Excellence was completed in April 2016, and Sharp reports that it began commercial packaging activities in June.

As a result of the expansion, Sharp will offer serialization at five of its packaging sites and plans to add 4-5 lines per quarter through 2017. Sharp has been providing serialization services to clients since 2008, serializing more than two billion units in six different formats for 35 client programs.

PMP News asked Rick Seibert, Senior Vice President, Global Innovation and Technology Services for Sharp Packaging Solutions, a few questions about serialization, the expansion, and more.

PMP: What challenges is the pharma industry facing now with serialization, and how does this recent investment from Sharp help?

Seibert: One of the biggest challenges currently faced by the pharma industry with respect to serialization is the reality of implementation lead times in the face of the DSCSA deadline. There are a number of critical elements in the supply chain that pharma companies need to align in order to become serialization ready, including assessing and ensuring that their network of CMO and CPO partners themselves have a robust serialization strategy in place and have a proven technical architecture to support it. Sharp has been serializing since 2008 and has developed an experienced team of serialization experts as well as strong relationships with our technical partners. 

Another challenge faced by pharma will be the ability to find CPO partners that are serialization ready and have available capacity. Our recent investment of $45MM to open our new Biotechnology Center of Excellence allows us to offer an additional 30% capacity in the United States in addition to our available capacity in the EU at a time when there will inevitably be a capacity-crunch as the deadline for serialization looms. The early indications for success are there for those making the hard decisions now to consolidate their partner network and de-risk their serialization readiness by decoupling their packaging requirements. Sharp has been working proactively with our existing customers to ensure that we have visibility of their serialization plans and offering them—in collaboration with our partners—a proven implementation path.

PMP: What other challenges is the Pharma industry facing, and how can Sharp help?

Seibert: The pharmaceutical industry is under enhanced pressure from emerging regulations on an international scale (FMD for the EU, 40+ other countries considering legislation on serialization). Sharp is in the unique position of having serialization programs and strategic partnerships in place, having started serialization eight years ago. We can draw upon that experience to help our clients more effectively deal with these changes.

In addition, there are increasingly complex and specialized medications entering the marketplace that will require not only the particular packaging expertise that we can provide, but also enhanced skill sets on the part of company and CSO sales representatives in order to service the supply-chain needs of pharma/biotech. The increased M&A activity occurring in the marketplace is requiring a level of coordination and planning not seen before and is resulting in more strategic relationships with outsourced service providers such as Sharp in packaging, and our sister company, Ashfield, in commercial and clinical endeavors.

The constant price pressure by "payers" and government payer programs is also resulting in continued outsourcing initiatives. Those outsourced providers with the deepest experience level will certainly be the attractive resource, and Sharp has global experience in all packaging formats.

PMP: What are Sharp’s future plans?

Seibert: Sharp will continue to add and refine the type of services provided to our pharma clients above and beyond traditional packaging services, including design, engineering, clinical/formulation development, serialization, supply chain visibility, and data collaborations. We will persist in the refinement of our customer relationship model to grow relationships with clients strategically, what we call our “EDGE” initiative. We will continue to automate current processes and eliminate inefficient manual intervention and follow productivity improvement initiatives along with the organic growth of our state-of-the-industry facilities while maintaining investment into technology-based solutions in support of emerging serialization-based regulatory requirements.

For more details visit www.sharpservices.com or read our article "Demands on pharma are changing--and so is the packaging support."

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