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PCI Pharma Services’ presence at CPhI Worldwide 2018 (October 9-11, Madrid, Spain – Stand 3F10) will highlight considerable growth and expansion, including acquisition and integration of providers in three key geographies, reaffirming the organization’s industry-leading position as a full-service provider of specialist outsourced drug manufacturing, clinical trial services, and commercial packaging to the global biopharmaceutical industry.
In the 12 months since CPhI 2017, PCI has continued to focus its strategic investment on supporting the biopharmaceutical industry with global access, matching this trend with an enhanced international presence to ensure drug development, manufacturing, packaging and supply services for the benefits of its clients and their patients in more than 100 countries across the world.
PCI’s strategic approach and international perspective has ensured the organization is strongly placed and prepared for continued industry change. With Brexit pending for the UK and EU, and important regulatory deadlines approaching in the US and EU as well as for emerging market countries, PCI stands ready to ensure service continuity following considerable growth and strategic expansion.
In October 2017, PCI’s acquisition of Millmount Healthcare in Dublin, Republic of Ireland signalled the organization’s proactive Brexit strategy, expanding its existing European footprint outside of the UK and reinforcing its commitment to the EU market.
To help mitigate Brexit risk, PCI has strengthened its EU presence further still. A series of site expansions and investments ensure business continuity for its global customer network in the wake of Brexit. These include a purpose-built laboratory to support EU release. PCI has also expanded its footprint further in Europe to service its customer base in the EU as a mitigation plan for the contingency of a no deal Brexit.
Regulatory changes – DSCSA, FMD, traceability and Serialization investment
In its market-leading global position, PCI’s strategic program of investment and expansion has continued across its global network throughout 2018. PCI’s proactive approach has ensured that the organization is ready and compliant in advance of key regulatory implementation dates – including the US DSCSA in November 2018, the EU FMD in February 2019, and emerging market traceability deadlines.
PCI’s Serialization and anticounterfeiting technology investment sets the industry benchmark, with more than 80 lines installed and actively supporting commercial products destined for the US, EU and other emerging markets.
International reach investment
Meanwhile, PCI has been on the acquisition trail since CPhI 2017 to complement and further enhance its services and global footprint. The Dublin acquisition of Millmount Healthcare in October 2017 was one of three that PCI has announced in the past 12 months, and the fourth in four years outside of the US. The other acquisitions being Pharmaceutical Packaging Professionals (PPP) in Melbourne in March 2018, providing new access to Australia and the wider Asia-Pacific region; and Sherpa Clinical Packaging in San Diego, CA in September 2018, extending PCI’s presence across the US to the West Coast. All three regions are critical hubs for the industry’s biopharmaceutical development.
Early stage development investment
PCI continues to invest in services to support client development and commercialization of new medicines, focusing on services and technologies that provide speed-to-market. To this end, the organization has maintained its focus on and investment in early stage development including rapid services for expediting early phase clinical studies, expert formulation and drug development solutions, new capabilities for early stage manufacturing development including sterile drug deliveries, as well as advanced packaging technologies to get developmental product into study quickly.
“PCI’s clients trust us to help support lifesaving medicines to patients all around the world. With the increasing pressures on the industry, clients need solutions that are nimble and flexible to address global uncertainties, equipped to provide true speed-to-market, and strategically positioned in key geographies to reach their desired markets,” commented PCI Chief Executive Officer, Salim Haffar. “PCI has a focused strategy of considerable investment in our existing global supply network – implementing advanced technologies and continued expansion of capacity, coupled with key targeted acquisitions, to provide a comprehensive solution for our clients’ needs. This includes investment in all facets of lifecycle management; helping expedite molecules into clinical study, ensuring effective transition of various clinical trial phases, successful commercial launch and reliable ongoing supply. Investment, paired with expertise and outstanding service, provides a framework for providing outstanding results.”
PCI’s impressive achievements since CPhI 2017 include increased geographical reach through acquisition, expanded site capacity, additional market-leading technologies and equipment. The key milestones include:
- September 2018 – acquisition of Sherpa Clinical Packaging, enabling PCI’s expansion to West Coast, US
- August 2018 – expanded Cold Chain infrastructure at North American Center of Excellence for Clinical Services with dedicated -40°C facility, Rockford, IL, US
- July 2018 – leadership transition building on strong growth and customer focus: Salim Haffar announced as new CEO and Bill Mitchell as Executive Vice Chairman, effective September 2018
- June 2018 – completed installation and validation of new Serialization suite at Center of Excellence for contained manufacturing, Tredegar, UK
- April 2018 – launched new high containment packaging facility, Dublin, Republic of Ireland
- March 2018 – announced expansion of Analytical Laboratories at Center of Excellence for contained manufacturing, Tredegar, UK
- February 2018 – completed installation and validation of new Serialization suite, Dublin, Republic of Ireland
- March 2018 – established Asia-Pacific HQ and strengthens position in market with acquisition of Australia-based Pharmaceutical Packaging Professionals (PPP)
- January 2018 – newly expanded European Center of Excellence for Clinical Services completed validation and licencing and is operational, Bridgend, UK
- November 2017 – celebrated 50th anniversary of PCI’s contract packaging services, Rockford, IL, US
- October 2017 – announced new fully contained Xcelodose® 600S technology at Center of Excellence for contained manufacturing, Tredegar, UK
- October 2017 – acquired Millmount Healthcare, Dublin, Republic of Ireland – expanding PCI’s packaging capabilities with an EU footprint
To hear more about PCI Pharma Services, visit Stand 3F10 at CPhI Worldwide, or click here.