Original Equipment Manufacturing (OEM) servicesProducts for single-use and cell culture applications

We are known for using high-quality manufacturing processes. Our bioproduction supply team assists you to develop and commercialize solutions for the bioproduction market, ranging from cell culture media to reagents, buffers, and process liquids to single-use bags, connectors, and components. We have built our business around the ability to customize and confi gure the right tools for our customers.

Just as important is our ability to develop in-process, single-use products for vendors and suppliers in the life science, medical device, and pharmaceutical industries. We offer numerous benefi ts to our private label clients through supply chain management and excellence in manufacturing.

Our solution• Helping you achieve your business objectives by

developing strategic manufacturing collaborations leveraging our time-tested, know-how expertise in global supply chain management and manufacturing

• Total cost of ownership strategies by aligning your objectives, enabling productivity and effi ciency

• Providing contract manufacturing and support of single-use fl uid handling products that are focused on the bioproduction and medical device industries

• Utilization of our high-quality manufacturing facilities and processes

• Leverage our purchasing power with our raw material suppliers

• Helps mitigate risk and provides manufacturing redundancy

• Our facilities operate in compliance with regulatory bodies and guidelines such as ISO, cGMP, and Annex 1*.

* Applies to our large-volume liquid facility in Grand Island, NY.

Why outsource the manufacturing of single-use and cell culture products?

Benefits of our manufacturing network• On-site resources for supply

management and support services

• Compliance qualification

• Cost of operations

• Supply assurance through a global manufacturing and distribution network

Optimized supply management• Asset management services

and systems

• Product rationalization and standardization support

Support cost savings initiatives• Regulatory compliance support

• World class portfolio to support vendor consolidation efforts

• Reduce manual processes

• Volume and other incentives to drive alignment and impact

• Cost of maintenance, services, and calibration

• Ongoing testing and compliance: cost of quality

Delivering quality products and building your supply chain confidenceOur commitment to qualityQuality by design, robust quality systems, practical process improvement, and supply chain transparency helps you to make your products safer and better.

• Our facilities meet industry quality standards

• Host over 200 customer site audits per year

• Over $40 million investment in operational expansion since 2015

• Consistently assess the quality management system (QMS) for continuous improvement

• All cell culture sites are cGMP compliant

• Express services available for single-use applications and cell culture to help ensure you get the quality product you need when you need it

Assurance of supply—key initiatives to deliver your supplies when you need themBusiness continuity • Redundancy of manufacturing for key cell culture and single-use products

• Plans for effective prevention and recovery from operational disruption

• All sites environmental, health and safety (EHS) compliant

Safety stock • Maintenance of intermediate and finished goods safety stocks

• Product can be shipped from our warehouses typically within 2 days after your request for single-use products

• Approximately 5 million liters of finished goods stored each month for cell culture

Demand planning • Help eliminate lead times by aligning our production schedule with yours

• Some products can be available 4 weeks prior to your target date

Our footprint and capabilitiesSingle-use technology manufacturing sitesLogan, UT—Assembly CenterThis is our primary site for assembling BPCs, fluid transfer assemblies, and manifolds. In addition to manufacturing in ISO 7 cleanrooms, the Assembly Center site also houses quality control and assurance, materials management, procurement, and production scheduling teams.

Logan, UT—BioCenterOur BioProcess Container Operations Center (BioCenter) is our primary BPC chamber manufacturing facility. The BioCenter also houses our engineering laboratories, quality control and assurance, project management, product management, sales operations, finance, and human resources; as well as our applications, ISO 7 cleanroom manufacturing, and research and development engineering teams.

Millersburg, PAOur Millersburg site includes an ISO 7 cleanroom manufacturing, assembling BPCs, and fluid transfer assemblies. In addition to manufacturing, this site also houses quality control and assurance, materials management, procurement, and production scheduling teams.

Matamoros, MexicoOur Matamoros, Mexico site specializes in ISO cleanroom manufacturing of ethyl vinyl acetate (EVA) and polyvinyl chloride (PVC) products for the bioproduction and general medical device industries, and serves customers with design customization and production of simple and complex configurations. Design engineering, quality control and assurance, global trade compliance, and manufacturing are resident departments.

Cramlington, UKOur European BPC operations site is situated in Northern England. Because of recent upgrades and expansions, this site significantly expanded our overall capacity to serve the increasing demand for BPCs, fluid transfer assemblies, and manifolds. The upgrades also provide enhanced chamber manufacturing redundancy. The BPC manufacturing area currently consists of an ISO 7 cleanroom and support areas. This facility houses final assembly for BPCs, transfer assemblies, and manifolds.

Logan, UT—Assembly Center

Logan, UT—BioCenter

Millersburg, PA

Matamoros, Mexico

Cramlington, UK

Cell culture manufacturing sitesThe Gibco™ media network provides a global supply of cell culture media and components from multiple facilities: Grand Island, New York, Inchinnan, Scotland, Auckland, New Zealand, and Newcastle, Australia. Grand Island and Inchinnan offer full product customization, so customers can experience redundant supply and regional media sourcing for formats:

• Liquid media, buffers, and concentrates

• Dry powder

• Advanced granulation technology (AGT)

• Sera distribution

Thermo Fisher Scientific has made a significant investment in business continuity planning by building an animal origin–free (AOF) manufacturing facility in Inchinnan, Scotland. This production facility for dry powder cell culture media creates redundancy with the Grand Island, NY manufacturing facility. Inchinnan and Grand Island are both certified ISO 13485:2003, and EN ISO 13485:2012, and manufacture products according to 21 CFR Part 820 cGMP.

Inchinnan, Scotland

Grand Island, NY

Find out more at thermofisher.com/oemservices

For Research Use or Further Manufacturing. Not for diagnostic use or direct administration into humans or animals. © 2017 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. COL03473 0317

Contact us today if you need a partner for private label manufacturing and support of single-use fluid handling products, media, supplements, cells, and cell culture media reagents that are reproducible and enable performance results.