Learn about the two companies that received Honorable Mentions for the 2018 Facility of the Awards:
Emergent BioSolutions, Inc.
Government Pharmaceutical Organization (GPO)
Emergent BioSolutions, Inc.
Location: Baltimore, MD, USA
Project: BARDA – Emergent Center for Innovation in Advanced Development and Manufacturing (CIADM) Baltimore Facility Expansion
Emergent – BARDA Center for Innovation in Advanced Development (CIADM) Baltimore Bayview Facility Expansion is recognized as Honorable Mention. The facility represents a unique partnership between industry and Government that can act rapidly to stop significant public health threats. The facility expansion comprised erection of a three-story steel framed structure with the building expansion adding 56,000 sq. ft to an existing 56,000 sq. ft building.
Emergent’s CIADM facility is one of three facilities in the US developed with the primary purpose of providing rapidly deployed development and manufacturing capabilities in response to a global pandemic. With the design and construction of this facility, Emergent had notable accomplishments including:
- The facility is highly adaptable to fluctuations in demand and is designed for multi- platform, multi-process and multi -scale production
- The facility is capable to manufacture, test and release of 50 million doses of pandemic flu vaccine within four months of pandemic declaration.
- The facility is highly flexible with the capability to manufacture cell culture, microbial and viral hosts and can plug in or remove unit operations to match any potential process.
- Manufacturing suites capable of accommodating various processes irrespective of equipment arrangements and product flows – with utilities in each processing room.
- Adoption of disposable single use technologies upstream including ABEC 4000-liter bioreactors
- Manufacturing data control technologies, automated process control and monitoring islands combined with integrated building systems for precision operational awareness and control
FOYA is recognizing Emergent with an Honorable Mention for their innovative efforts to design and construct a highly flexible and adaptable facility capable to respond to both known and unknown future pandemic threats.
Key Participants:
- Engineer/Architect: CRB
- Construction Manager and Main/General Contractor: CRB
- Piping Subcontractor: Kinetic Systems, Inc.
- HVAC Subcontractor: Pro-Air, Inc.
- Automation and Control Supplier: Omni Instrumentation Services, Inc.
- Major Equipment Supplier(s)/Contractors: Rosendin Electric, Inc./Iacoboni Site Specialists, Inc., ABEC
Government Pharmaceutical Organization (GPO)
Location: Pathumthani, Thailand
Project: Rangsit Pharmaceutical Production Plant 1
The Government Pharmaceutical Organization (GPO) is recognized by the judging panel for its success in applying Quality by Design principals and international best practices to construct the Rangsit Pharmaceutical Production Plant 1 to manufacture affordable, HIV medicines for the people of Thailand.
GPO is the largest pharmaceutical producer and distributor in Thailand. The Company purchases API from outside countries and produces formulated products which it distributes through government contracts. In 2016, GPO received accreditation with the GMP PIC/S International standard from Thailand’s Food and Drug Administration.
The Rangsit project, constructed in association with the WHO program to create regional supplies of critical medicines, set out to satisfy three core needs:
- Provide medicines to address Thailand’s dengue fever, malaria and HIV epidemics. The HIV problem is particularly severe in Thailand with an estimated 450,000 living with HIV.
- Provide these medicines at a cost affordable to the local population as product sourced externally is unaffordable to many.
- Manufacture these medicines in accordance with PIC/S, the regulatory standard recently adapted by the ASEAN group of nations.
Traditionally, GPO used paper-based systems for all processes which required a large amount of manual data entry and transcription with a varying effect on product quality. The company had a major challenge managing their existing paper records. So, from the outset, the Rangsit project team worked to provide an integrated IT system to control the various processes and ensure data integrity using paperless operations drawing from international inspection standards.
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The team mapped existing manual processes and an existing ERP system to identified gaps with PIC/S. They applied an ISA 95 based approach to develop the integrated IT solution and a GAMP 5 approach to use standard modules and components to reduce validation requirements and project risk. Systems from leading vendors provided the best practice and lowest cost solution to meet their needs and compliance standards. The building, its support systems and OSD manufacturing equipment were installed in accordance with PIC/S standards.
The result was the localized production facility with efficiencies gained from its integrated IT systems is reported to produce the HIV medicines for a price 20 times lower than imported medicines while achieving global quality standards.
The FOYA judges compliment GPO’s new facility, its deployment of a modern quality management system and honors its success in providing affordable HIV medicines to the people of Thailand.
Key Participants:
- Engineer/Architect: The Government Pharmaceutical Organization
- Construction Manager and Main/General Contractor: M+W Thailand Co.,Ltd.
- Piping Subcontractor: M+W Thailand Co.,Ltd.
- HVAC Subcontractor: Airplus Apply Co.,Ltd.
- Automation and Control Supplier: The Auto-Info Co.,Ltd.
- IT Solutions Supplier/Compliance Consultants: FactoryTalk, Co. Ltd
- Major Equipment Supplier(s)/Contractor(s): Unitech Co.,Ltd/Schneider Thailand Co.,Ltd.