Vacation. We all look forward to it. A week or so away from the office to decompress and reduce stress – sounds great doesn't it? The vacation industry caters to those of us who want a stress-free vacation – the all-inclusive option. These all-inclusive resorts typically offer all the amenities a weary vacationer could want – food, adult beverages, entertainment and the service to match – neatly bundled into one package.
No one would ever say that developing, manufacturing and packaging a new pharmaceutical is akin to a vacation, but Almac, a CMO with headquarters in Ireland and a growing presence in the United States can help alleviate many of the stresses and concerns inherent in pharmaceutical manufacturing with a range of services that encompasses everything a sponsor might need to get a drug to market as quickly and efficiently as possible.
Background and History
Almac in its present incarnation has been around since 2006 – but the roots of the company go farther back. In 1968 Alan McClay, at the time a sales representative for Glaxo, had a vision of what a pharmaceutical services company should be and launched Galen. He started in his home country – Ireland – and set up various pharmaceutical service companies to assist companies with all sort of pharmaceutical business and process activities.
“He had the vision to ask what else does the pharma industry need,” says James McGibbon, Almac’s Director of Business Development, Pharma Services. “In Ireland – he built up a synthesis company and also set up a formulation company and manufacturing company – he was thinking way ahead of his time.”
Galen’s success in Ireland eventually led the company to go public. With his profits McClay acquired Warner-Chilcott in 1999. Unfortunately the merger of Galen and Warner Chilcott was not a smooth one, and after resigning from the board, and selling his stock, McClay spent the next four years buying back the company he created. By 2006 he was able to reformulate and relaunch his company as Almac – a now private company which was under his ownership.
McClay then set up a foundation to run the company. Profits from running the various Almac businesses are reinvested into the foundation to support issues McClay thought were important such as employment, cancer research, etc. When he passed away in 2010 all of his assets were transferred to the foundation he created.
Almac’s UK headquarters is located in Craigavon in Northern Ireland, and as McGibbon points out it is unique in the contract services world. The Craigavon site boasts 2200 people working in all phases of drug development including:
Commercial Manufacturing and Packaging
Product Launch and Distribution
The Craigavon site is a highly integrated site offering continuity of service and enhanced communications benefitting from all divisions being in close proximity to each other.
McClay’s vision was always to take what he had created in Ireland and replicate that success in the United States. In May of 2002 he acquired a 50 acre site in Souderton, Pennsylvania and established Almac’s United States headquarters in that location. The Souderton site currently houses clinical manufacturing and packaging, analytical stores and distribution and administrative and client functions.
Almac now organizes itself across five business units:
Biomarker discovery and development
API Services and Analytical Services
Almac Pharma Services
Almac Clinical Technologies
Almac Clinical Services
Clinical trial supply
The latest addition to Almac’s range of services in the US falls under the Pharma Services umbrella and is embodied in the company’s recently completed Audobon, PA commercial packaging facility.
Commercial Packaging in the United States
The facility that is now the site of Almac’s commercial packaging operations has actually been in the Almac “family” since 1996. During the depths of the real estate recession – there was some talk about selling the facility – but then it was decided it would make an ideal location for the company’s US packaging operations, and the site was converted to commercial packaging.
“The idea behind this facility," says McGibbon, “is if you have us develop, formulate and do clinical materials and then scale up and manufacture the product we can now also do the final packaging here. This facility is the final piece of the puzzle.”
Also, referring back to Almac’s organization structure, McGibbon puts the new Audobon packaging facility in the "center" of the company - as the facility and its people and expertise work with the early and later stage people, the formulation groups and the commercial launch groups.
The Audobon packaging facility took approximately 18 months to get ready for the FDA. In January of this year the facility was inspected by the FDA and passed with flying colors – no 483s were reported. In addition the facility was inspected by the DEA in January and received all necessary approvals.
Almac refitted the facility with four packaging lines and did all the validation work necessary for start-up. According to McGibbon throughout the entire fitting out and validation process the main focus was on quality.
“Obviously quality is very important,” says McGibbon. He continues, “We transferred the proven quality systems from Ireland and also the SOPs. We had to tweak the SOPs a bit to meet US requirements but they are very similar overall.”
The facility is currently in start-up mode, says McGibbon. “We know exactly what we are doing. The packaging capability we have here is based on years of packaging experience.”
Inside the Facility
The commercial packaging services at Almac’s Audobon facility focus mainly on packaging solid dosage product and include:
• Blistering and Cartoning
• Blistering and Walleting
• Bottling and Cartoning
• Vial Labelling and Packaging
• Kit Assembly
• Analytical Support Labs
The biggest investment Almac has made was the purchase and installation of the Uhlmann blister line. While blisterpacks are more popular in Europe right now Almac sees them as a growing trend in the United States especially as more emphasis is put on patient compliance.
The Uhlmann UPS4 line that is installed in Audobon offers:
• Versatile blistering for all solid dosage forms
• High-speed output – 12,000 blisters/hr.
• Hapa Hybrid printer for variable data printing
• VisioChrom online verification of print.
The blisterpackging line also has the capability to be easily switched from thermoforming to cold forming based on product requirements.
The bottling line features a Swift Pack machine that is capable of handling tablets, capsules and softgel capsules. Feature of the line include:
• Bottle blower
• Desiccant inserter
• Swiftvision electronic counter
• Target fill of 7,200 container/hr
• Cotton inserter
• Dico capper
• Induction sealer
• Optical character verification system
While the facility is primarily focused on packaging solid dosage products it also offers a state of the art vial labeling capability. The installed Newman 4VAL vial labeler offers:
• Automatic vial and ampoule labeling
• Optical character verification system
• High speed output – 3,000 vials/hr.
The facility also offers an area for complex manual kit assembly which includes medication kits, diagnostic kits, sample kits and patient information and marketing packs.
Also on site is a ZED 15RS Heat Seal Wallet press which is a semi-automated rotary heat sealer for conventional carded blisters and medical and/or pharmaceutical applications using materials such as Tyvek, foil, thin plastic and laminated film stock. Output of the Zed press is 1800 wallets per hour.
One of the interesting aspects of the facility is the company’s requirement for complete gowning in all of the packaging areas. Typically packaging areas are not required to be kept as clean as sterile processing areas but at Almac they feel the need to surpass what others in the industry are currently doing. According to Andrew Spence, Almac’s United States Director of Quality, Almac has always required gowning in their packaging areas. “As a contract manufacturer we have always done this – we find we need to go above and beyond what others have to do – some international agencies have very strict rules regarding gowning – so we meet the highest standards in the world. As a contract manufacturer – we see a lot of audits – and we do a lot of environmental monitoring – there is no requirement for it – but we do it to keep customers happy and we like to have a clean environment. Gowning procedures were first implemented in our Ireland facilities and we now do it here – for consistency.”
Capabilities and Services to Support Packaging
To support the facility’s packaging goals Almac has equipped the facility with state-of the art analytical labs to ensure all incoming materials are in compliance with approved specifications. In addition all bulk drug products and components are tested for identity through the use of technologies such as HPLC, UV and FTIR. The analytical labs also support the facility’s environment monitoring procedures - testing production equipment for cleanliness and also ensuring the GMP zones are in compliance.
One of the key features of the facility, and one that ensures a smooth operation, is its extensive storage and warehousing capabilities. Almac’s large and modular storage facilities offer the flexibility and capacity to store raw materials, unlabelled stock and finished goods in either controlled ambient of refrigerated areas. The facility also boasts a secured vault for storage of all schedules of controlled drugs, and all storage areas are mapped and continuously monitored.
The entire facility and its production processes are controlled and monitored by an ERP system. When production is ready to start for a new product the ERP system generates pick lists for warehouse personnel to secure the needed packaging materials and bulk drug substances. Handheld devices are used to scan bar codes on the bulk packages to ensure accuracy.
All items are moved to a staging lobby where packaging people get the material and move it into production
Spence says that Almac’s ERP is very configurable and was designed to the company’s specifications.
And finally, if needed, Almac also has in-house packaging design services that use the latest technology for packaging design.
With all of the pieces in place Almac has a lot to offer a potential partner. And as McGibbon emphasized Almac’s highly integrated service offerings is what differentiates it from others in the pharmaceutical contract industry. But there is more to it than just offering comprehensive services. “We offer a stable alternative at a time when there has been a lot of change in the industry,” says McGibbon. “Almac is stable and has been around a long time.”
Finally, Graeme McBurney, President & Managing Director, Almac Pharma Services offers his thoughts “We are delighted to have established US commercial packaging operations in Audubon, PA. With recent FDA approval and the commencement of blister and bottle packaging for one of our long term client partners, the facility has got off to a great start! The alignment of our packaging processes at both our UK and US sites, offers future clients the highest levels of customer service and continuity of supply, through a flexible and quality led operation.”