HyClone buffers
and process
liquids
Workflow solutions

Our customer focus
Cytiva continues the mission of being the leading supplier of quality solutions
to challenges faced in life science research and the biopharmaceutical industry.
A consistent global quality management system ensures security of supply of buffers
and process liquids, with equivalent quality standards and performance across theglobe. With a strong commitment to progress and growth, our customers’ needs
fuel our development of innovative products and solutions for both upstream anddownstream workflows.

We offer• Product excellence, customer-centricity, and innovation for more than 45 years• Global production facilities, providing on-time delivery• Custom bulk production services for bioproduction scale-up• Supply chain partnership for efficient and cost-effective solutions• Products and solutions for both upstream and downstream applications

HyClone buffers and process liquids
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Our buffers and process liquids feed
the entire bioproduction workflow

WAVE Bioreactor™
system and ReadyKart

Media hydration andsupplementation

Cell handling andharvest

Water for injection (WFI)
quality water and glucose
solutions

Buffers and balanced
salt solutions

Xcellerex XDRbioreactor system

Filtration
Flush and digestion
solutions

Inline Conditioning
systemBuffer preparation,
in-line conditioning
and dilution
Buffered saline solutions,
WFI quality water, bufferconcentrates, and stock
solutions

UniFlux™ crossflow fi­ltration systemwith Xcellerex Quad mixing system

Viral inactivation
Acids, detergents,and surfactantsÄKTAprocess™
chromatography system

Chromatographic
operations

Column regeneration,cleaning, and storage

Custom buffers;
phosphates, citrates,
acetates, Tris, HEPES,
and more

Ethanol, NaOH, and NaClsolutionsAxiChrom™
columnWashing and rinsing
Water and dilute saltsolutions

ReadyToProcess™
hollow ­fiber
filtration cartridge

System cleaningand sanitization
Water, ethanol andNaOH solutions

HyClone buffers and process liquids

Xcellerex™ XDUO
mixer system3

Breaking thebottleneck
Focusing critical resources
Buffer production suites and the required utilities to run them
are major capital investments when building a bioproduction
facility. Additionally, buffer manufacturing is one of the moreresource-intense activities and can rapidly become a bottleneckin the overall workflow. Because of this, many facilities are quickly
outgrowing capacity and ultimately become undersized.
We can help free up space by providing just-in-time, high-quality
custom and standard bulk fluids in containers and packaging sizesof your choice for both upstream and downstream applications.

Customization
Development and scale-up of bioprocesses frequently require
quick manufacture of prototype buffers to facilitate timely processevaluation and fast implementation. Cytiva offers Rapid Response
Production (RRP) services for fast delivery of small volumes of prototype
buffers, which can easily be transferred to GMP production.

As an expert in custom buffer supply, we set up, manufacture,and deliver hundreds of new customer-specific formulations yearly.
Because successful bioproduction requires many, often unique,solutions, we tailor each solution to your specific formulation andpackaging requirements.

HyClone buffers and process liquids

GMP custom products

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Globalmanufacturing
Our manufacturing facilities are designed to meet stringent
regulatory production and distribution requirements, while serving
the global biopharmaceutical market. With facilities around theworld, we are able to provide buffers and process liquids in lot sizes
and delivery systems suitable for your application.
Buffers and process liquids are produced in traditional stainlesssteel tanks or in single-contact manufacturing systems. We alsooffer dedicated animal-derived component free (ADCF) mixing
systems where appropriate.
For preblended powdered buffers, our pin mill powder manufacturing
facility offers a high level of quality and consistency. Additionally,
we offer technical support for hydration at your facility.

Traditional stainless steel tanks• Up to 10 000 L batch capacity• Closed system sterile filling

Single-use manufacturing systems• ADCF film contact surface

Powder manufacturing• > 6000 kg powder manufacturing batch capacity• Dedicated ADCF powder facility

HyClone buffers and process liquids• Up to 10 000 L batch capacity5Flexible packaging
By combining our large-scale production capabilities with efficient packaging options,buffers and process liquids can be delivered to your facility when you need them,allowing you to focus resources on your core capabilities: manufacturing ofbiotherapeutics and vaccines.
We have a wealth of experience in providing buffers and process liquids in large-volumedelivery systems. These systems have been extensively tested for product integrity andcomply with internationally recognized transportation requirements. We work with clientsto customize delivery systems that support ease-of-use in your facility.
Buffers and process liquids are packaged in single-use containers and shipped in thefollowing configurations:• Corrugated shippers for single-use container volumes in the 500 mL to 20 L range• Bottom-drain drums for single-use container volumes in the 50 to 200 L range• UN liquid-rated drums for single-use container volumes in the 20 to 200 L range• Palletized bins for single-use container volumes in the 250 to 1000 L range

Logistics
Our logistics experts arrange and ship multiple domestic and international shipments
every month in air, land, and ocean containers. Logistics experts coordinate customer
shipments and work with regulatory agencies to ensure domestic and international
trade compliance.
HyClone buffers and process liquids

Shipments can be managed frozen (-20°C), cold (2°C to 8°C), or in ambient
temperature; in insulated small packages or pallets in active-temperature freightcontainers and temperature-controlled trucks. Temperatures are monitored using
data recorders to ensure consistency and reliability.

6Commitment
to quality
Throughout the design and manufacturing process, every aspect of your HyClone™
product meets stringent quality requirements and offers a high level of performance.
We take a three-step approach to quality control for HyClone products: quality bydesign, process control, and key attribute performance testing.

Quality management
To meet your documentation and regulatory requirements, ourquality management is consistent in procedure and raw materials
for lot-to-lot equivalence across our global manufacturing
sites. Our segregated ADCF manufacturing uses single-use
liquid management systems that minimize cleaning and cleaningvalidation requirements and alleviate cross-contamination concerns.

Validated, documented, and aligned
production according to:

Quality by design at Cytiva means evaluating suppliers; performing design failuremode effect analysis and process failure mode effect analysis; conducting designof experiments; and building quality into the manufacturing facility design.

• Medical device current good manufacturing practices(GMP) 21 CFR 820

Process control enables consistent processes that continue to improve. We relyon statistical process control; process qualification and validation; and continuousimprovements. Key attribute performance testing allows us to test products for
quality at every stage of the manufacturing process, even well before the process
starts with raw material testing, in-process testing, and finished goods testing.

• ISO 9001

With rigorous quality management systems, we consistently meet internationallyrecognized regulatory requirements and customer expectations throughout ourcollaborative process.

• ISO 13485 for medical devices• Eudralex Annex 1 alignedRaw materials• Robust vendor management program to enable sourcing from
qualified and audited raw material suppliers• Multiple qualified raw material sources for risk mitigation andcontingency planning purposes

HyClone buffers and process liquids• Raw materials meeting our quality requirements as well as
requirements of United States, European, and/or Japanesepharmacopeia

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cytiva.com/hyclone
Cytiva and the Drop logo are trademarks of Global Life Sciences IP Holdco LLC oran affiliate. ÄKTAprocess, AxiChrom, HyClone, ReadyToProcess, WAVE Bioreactor,UniFlux, and Xcellerex are trademarks of Global Life Sciences Solutions USA LLC
or an affiliate doing business as Cytiva.
© 2020 Cytiva
For local office contact information, visit cytiva.com/contact

CY14251-19Oct20-BR