Interview Partner:
James McGibbon
Director Business Development
Almac Pharma Services
Why did Almac make the decision to expand into the US and open a commercial packaging facility?
The rationale in opening a commercial packaging facility in the US was two-fold. One – demand from our US clients for a fl exible, quality-driven commercial packaging partner and two – the Audubon site was readily available. Almac have owned the site in Audubon, PA since 1997. Originally the facility provided contract clinical packaging services that relocated to Almac’s North American Headquarters in Souderton, PA at the beginning of 2011. Work to re-task the Audubon facility to a commercial packaging plant commenced Q3 2011 with an investment in excess of $10m and completed with a successful FDA inspection in February 2013.
What role does the new Audubon facility serve in the Almac network of plants?
Almac offers a broad and integrated range of services to the pharmaceutical industry from locations in the UK and USA.
In the US, Almac services were historically limited to clinical packaging, distribution and IXRS services. With Audubon operational, we are now able to offer our clients the option of integrated clinical to commercial packaging with our clinical packaging site at Souderton just 14 miles away or standalone commercial packaging.
The Audubon facility specializes in the provision of quality-driven, flexible commercial packaging solutions; from high volume marketed products to niche/orphan drug launches. We offer commercial primary and secondary packaging of tablets and capsules into bottles, blisters, wallets and hospital unit dose formats along with secondary labeling and packaging of biopharmaceutical presentations such as vials and ampoules. Complementing these services are dedicated teams in pack design & artwork management and in-house tooling fabrication. Signifi cant warehousing in ambient, refrigerated and controlled drug storage completes the services offering.
By having a single, integrated Quality Management System, coupled to a global ERP system between our UK and US operations, we provide a seamless operation, which meets the highest levels of customer and quality focus.
The facility was FDA approved in February 2013, are you packing any products yet for clients?
Yes, we are up and running and packaging drug product into bottles and blisters. Due to client confi dentiality we are unable to name specifi c clients; however, I can confi rm that our fi rst US client is a client partner with whom we have a long-established relationship with from pharmaceutical development and commercial manufacturing and packaging at our UK facilities.
In fact, we are manufacturing three branded generics (tablet and capsule dosage forms) at our UK facilities and then shipping the bulk drug products to Audubon for commercial packaging into bottles, blisters and wallets for distribution to the US market. These three products equate to over two billion tablets and capsules per year which translates to 2.5 million finished packs being released from the Audubon facility.
Additionally we are transferring some existing US packaging business in innovator products to Audubon from our UK facility – this will include blistered and sterile packaged products.
Does the facility have any specialist technologies?
We have invested over $3.3 million dollars in a state-of-the-art Uhlmann UPS 4 blister line. The versatile UPS 4 blister line processes solid oral dose products, providing primary packaging into a range of materials including PVC, PVC/ PVDC, Aclar and Alu/Alu. Complete with an integrated C2206 cartoner, the line provides a highly efficient packaging solution with an output of up to 12,000 blisters per hour, in a wide range of blister sizes.
The line is capable of both multi-product blister processing and online blister printing (both flexographic and digital), the latter significantly reducing packaging material costs.
Enhancing product compliance, the line includes a Total Quality Control Centre (TQCC) incorporating a checkweigher and integrated print and vision system for auto – rejection of incorrect print/ serialization data including 2D codes.
The blister line complements the full suite of highly flexible and state of the art commercial packaging equipment installed in the Audubon facility. Supporting high volume marketed products to niche/orphan drug launches, additional key technologies include bottling, walleting and vial labeling /packaging.
Are you getting requests for packaging technology to address the issue of serialization?
We have seen an increase in inquiries and understand serialization is becoming a critical requirement for our customers. We have developed a phased approach to serialization and established a multi-functional project team to support the technology and address the increasing problem of counterfeit, misbranded, and diverted drugs entering the pharmaceutical supply chain.
Phase I introduced an Overprint Serialization and Inspection System (OPSIS) utilizing a custombuilt software solution to support aggregation from unit through to pallet level. OPSIS was fully validated and released for use in our UK commercial packaging operations in January 2012. The current system was designed to allow supply of high value/low volume products to territories with an existing serialization/ enhanced unit overprint requirement.
With existing and emerging legislative requirements differing worldwide, and harmonization of serialization requirements still undetermined, Phase II is being designed to increase serialization/track and trace capabilities and extend a global end-to-end solution to all Almac clients. We are currently finalizing our vendor selection process and have completed a preliminary evaluation of our commercial packaging facility in Audubon, USA.