Subtitle

Filtration solutions from Cytiva

Request a sample or support

9 - 12 September, 2024

Kistamässan Exhibition & Congress Centre Kista, Sweden

Request a sample or support

Subtitle

Filtration solutions from Cytiva

Request a sample or support

19 - 22 September, 2024

Kistamässan Exhibition & Congress Centre Kista, Sweden

Subtitle

Filter validation services for low and ultra-low volumes

Accelerate clinical development with process‑specific validation using as little as 100 mL of drug product

Subtitle

Simplified tagged protein purification and tag removal

With Cytiva™ Protein Select™ resin and tag

12 September, 2024

De‑risk sterile filtration early with process‑specific validation supporting clinical progress

Talk to a validation specialist:

When every milliliter counts

Cytiva Fast Trak™ validation services offer process-specific validation tests for both standard and low/ultra-low volumes of drug product. Our low/ultra-low volume services use sample volumes from 100 to 1000 mL, ideal for early-phase programs where material is limited.

Available for Cytiva sterilizing-grade filters, these services include Supor™ Prime sterilizing-grade filters. They deliver 2x the throughput of PVDF filters, which can enable smaller filter sizes, reduce drug product loss from pre-conditioning and hold-up, and help maximize product recovery.

Together, our filtration technologies and validation expertise help generate robust validation data while minimizing the waste of valuable drug product.

All tests are designed to minimize drug sample requirements while ensuring regulatory compliance and product quality.

Tests include:
  • Bacterial viability and retention studies
  • Chemical compatibility assessments

50+
bespoke low/ultra-low volume validation projects (2018–2025)
3+
programs achieving marketing authorization (Europe, US, Japan)


Advantages of our low and ultra-low volume validation services

  • Flexible sample volumes: Cytiva provides flexible validation options for standard (>1.5 L), low volume (500–1500 mL), and ultra‑low volume (≤500 ml) drug sample volumes.
  • Technical expertise: With 50+ years of validation heritage, including 7+ years designing custom low/ultra-low volume studies, we are experienced at developing scale-down studies and clearly communicating risks and limitations.
  • Quality framework: We offer regulatory‑ready package to support your filing through comprehensive qualification work supported by quality management systems (QMSs) with standard operating procedures (SOPs) and approved protocols.
  • Regulatory insight: Our local regulatory insights provide confidence to design and defend validation aligned to local expectations.

SUPRAdisc™ II depth filter modules

Next generation in depth filter module technology for bioprocess clarification applications.

The SUPRAdisc™ II module design combines the filtration performance of Seitz™ media and the structural robustness of interlocking dual drainage plates.

Why choose low or ultra-low volume validation services?

9 - 22 September, 2024

Kistamässan Exhibition & Congress Centre Kista, Sweden

Our services are a good fit for:

  • Companies seeking early phase filter validation
  • Small‑batch drug products
  • Fluids with higher risk of bacterial penetration
  • High‑value drug products

What’s the state of sustainability for biopharma?

We heard from 800 biopharma leaders for our Sustainability Review.

The future of mRNA manufacturing is rolling in

We’re bringing our KUBio box trailer mRNA facility to you.

ÄKTA go™ protein purification system

Compact liquid chromatography system to support routine protein purification in research laboratories.

Typical project flow

  • Discovery: Review product, process, target claims, and available volumes with a project manager.
  • Scoping: Identify the possible drug-volume options, risk/limitations, and receive the scope-of-work and the quotation.
  • Custom scale-down protocol: Receive a representative low/ultra-low volume study design aligned to your manufacturing conditions and with applicable regulatory guidance, and formally approve it before the work begins.
  • Execution: Provide the drug product sample for conducting the recommended studies using minimal drug volume across any one of our global locations.
  • Data package and report: Receive a comprehensive validation report that substantiates regulatory compliance and withstands regulatory scrutiny.
  • Regulatory support: Get support to defend materials pre‑/post‑submission as needed.

Product specifications

ÄKTA go™ protein purification system

Throughput Up to 300 units per load / 1200 units per 8-hour shift
Pump type Peristaltic pump
Fill Volume Range 1.0 – 50 mL
In-process control Programmable up to 100% of units
Product contact materials Single-use flow path assembly
Interior classification ISO 5 / Grade A
Cleanroom classification ISO 8 / Grade D
Dimensions 1.7 x 1.5 x 2.2 m (5’6” x 4’9” x 7’2”)
Required cleanroom space 15m² (160 sq. ft.)
Electrical 208–240 VAC, single phase, 50–60 Hz, FLA 36

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Sed feugiat libero eu turpis tincidunt iaculis. In vel aliquam est, at porta neque. Donec hendrerit ultrices consectetur. Integer feugiat massa quis arcu ullamcorper, tristique facilisis massa feugiat. Phasellus risus mauris, pretium vitae tortor non, tristique fringilla tortor. Aliquam volutpat eros ac risus consectetur, quis gravida erat lobortis. Quisque id rutrum enim, sed fermentum nisl. Nulla volutpat turpis ac ligula venenatis maximus. In non dui ante.

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Praesent tellus neque, maximus sit amet mauris in, fermentum pharetra ante. Sed sit amet nibh commodo, fringilla lectus ac, dictum velit. Aliquam cursus feugiat congue. Aenean sit amet enim massa. Praesent mollis sagittis est, ut accumsan eros lobortis id. Maecenas at libero ex. Proin quis est vitae tortor ullamcorper pretium eu non nunc. Quisque at lacus accumsan, finibus sapien ac, viverra ligula. Donec commodo bibendum elit sit amet posuere. Curabitur rutrum.

Qualitative standard filter paper [2 or 3 items]

Whatman Grade 3 Qualitative Filter Papers

A standard grade filter used in qualitative analytical techniques to determine and identify materials. For use in büchner funnels.

Whatman Grade 5 Qualitative Filter Papers

A standard grade clarifying filter excellent for cloudy suspensions and for water and soil analysis.

Whatman Grade 226 Qualitative Filter Papers

A general qualitative filter with creped surface. High filtration speed, faster than grade 202 and retain coarse particles gelatinous precipitates.

Qualitative standard filter paper [3 or 4 items]

Qualitative standard filter paper

Whatman Grade 114 Qualitative Filter Papers

Whatman Grade 1575 Qualitative Filter Papers

Whatman Grade 2 Qualitative Filter Papers

Additional resources [2 or 3 items]

Protein characterization using size exclusion chromatography

Webinar

Tuesday, April 30, 2024

A standard grade clarifying filter excellent for cloudy suspensions and for water and soil analysis.

Whatman Grade 226 Qualitative Filter Papers

A standard grade filter used in qualitative analytical techniques to determine and identify materials. For use in büchner funnels.

Product carousel

Description

Product Comparison

ÄKTA go™

ÄKTA go™

Achieve desired purity with ease in routine purifications – make the most of valuable bench/cold-room space

ÄKTA pure™

ÄKTA pure™

Flexibility in research – match most current and future purification challenges

ÄKTA start™

ÄKTA start™

Entry level chromatography solution for the preparative purification of proteins in lab scale.

ÄKTA oligosynt™

ÄKTA oligosynt™

Compact, fully automated oligonucleotide synthesizer to support research and process development laboratories.

Support for affinity chromatography, ion exchange chromatography, and multimodal (mixed mode) chromatography yes yes yes yes
Support for affinity chromatography, ion exchange chromatography, multimodal (mixed mode) and size exclusion chromatography yes yes no no
Support for hydrophobic interaction chromatography yes yes yes no
Scale up, method development and optimisation using design of experiment (DoE) no yes yes yes
Automated: resin/column scouting, multistep purification, external equipment no yes no yes
Wavelength (nm) Fixed at 280nm Optional Fixed at 280, dual 260/280 or multi – up to 3 between 190-700 Fixed at 280nm Optional Fixed at 280, dual 260/280 or multi – up to 3 between 190-700
Recommended flow rate (mL/min) 0.01-25.0 0.001-25/0.01-150 0.01-25.0 0.001-25/0.01-150
Maximum operating pressure (Mpa) 5 20/5 7 20/4

    Watch the video below

    Beyond supporting your gene therapy processes with our technology and application knowledge, we're passionate about advancing solutions in areas where the status quo isn’t good enough. That's why we're excited to tell you about our ELEVECTA™ cell lines ― a significant advancement in viral vector manufacturing.

    Thank you for your interest! Here is your digital goodie bag from Cytiva.

    From posters and webinars to application notes and online learning, simply click on the links below to access some of our latest resources to support your cell and gene therapy advances.

    Agenda

    Agenda and schedules are subject to change. All times listed are in CEST.

    Monday, 3 February, 2025

    On the first day, we will welcome you all to Sweden at the site for a reception lunch. Have a bite to eat and chat with us and other attendees. Once fed and settled, we will commence the first workshops of the week. Simultaneously, a second group will be taken to the Cytiva Uppsala site to see where the magic happens.

    Time Details
    8:00 - 9:00 Registration
    9:10 - 10:40 Nestor Santiago and Gillian Goodwin Biacore™ system assay development revisited - Recipe for successful SPR data
    10:50 - 12:20 Cynthia Shuman and Eric Roush Slow and steady wins the race: Techniques for measuring slow dissociation rates using Biacore SPR system
    12:30 - 14:30 Lunch break
    14:45 - 16:00 Christin Radon and Emeric Gueneau Thinking outside 1:1 – Discover how to approach assay design for induced proximity and targeted protein degradation
    16:10 - 16:40 Anja Drescher and Mike Murphy Facilitating comparability with SPR-based surrogate potency assays and sensorgram comparison
    16:50 - 17:20 John Sinfield and Shannon Bryan Biacore™ Insight Software – A look beneath the surface: interesting facts and hidden features that will improve your workflows from start to finish

    Tuesday, 4 February, 2025

    On the second day, we will welcome you all to Sweden at the site for a reception lunch. Have a bite to eat and chat with us and other attendees. Once fed and settled, we will commence the first workshops of the week. Simultaneously, a second group will be taken to the Cytiva Uppsala site to see where the magic happens.

    Time Details
    7:00 - 8:30 Registration
    8:40 - 10:40 Nestor Santiago and Gillian Goodwin Biacore™ system assay development revisited - Recipe for successful SPR data
    10:50 - 12:20 Cynthia Shuman and Eric Roush Slow and steady wins the race: Techniques for measuring slow dissociation rates using Biacore SPR system
    12:30 - 14:30 Lunch break
    14:45 - 16:00 Christin Radon and Emeric Gueneau Thinking outside 1:1 – Discover how to approach assay design for induced proximity and targeted protein degradation
    16:10 - 16:40 Anja Drescher and Mike Murphy Facilitating comparability with SPR-based surrogate potency assays and sensorgram comparison
    16:50 - 17:20 John Sinfield and Shannon Bryan Biacore™ Insight Software – A look beneath the surface: interesting facts and hidden features that will improve your workflows from start to finish

    Wednesday, 5 February, 2025

    On the third day, we will welcome you all to Sweden at the site for a reception lunch. Have a bite to eat and chat with us and other attendees. Once fed and settled, we will commence the first workshops of the week. Simultaneously, a second group will be taken to the Cytiva Uppsala site to see where the magic happens.

    Time Details
    8:30 - 9:15 Registration
    9:25 - 10:40 Nestor Santiago and Gillian Goodwin Biacore™ system assay development revisited - Recipe for successful SPR data
    10:50 - 12:20 Cynthia Shuman and Eric Roush Slow and steady wins the race: Techniques for measuring slow dissociation rates using Biacore SPR system
    12:30 - 14:30 Lunch break
    14:45 - 16:00 Christin Radon and Emeric Gueneau Thinking outside 1:1 – Discover how to approach assay design for induced proximity and targeted protein degradation
    16:10 - 16:40 Anja Drescher and Mike Murphy Facilitating comparability with SPR-based surrogate potency assays and sensorgram comparison
    16:50 - 17:20 John Sinfield and Shannon Bryan Biacore™ Insight Software – A look beneath the surface: interesting facts and hidden features that will improve your workflows from start to finish

    Agenda single day

    Agenda and schedules are subject to change. All times listed are in CEST.

    Time Details
    8:30 - 9:00 Welcome and opening
    9:00 - 10:30 Stephan Poetsch ÄKTA™ chromatography systems family, system specifications and UNICORN with the new developments in the portfolio
    10:30 - 11:00 Break
    11:00 - 12:00 Stephan Poetsch ÄKTA™ basic care and troubleshooting - To prevent problems during protein purification
    12:00 - 13:30 Christin Radon and Emeric Gueneau Thinking outside 1:1 – Discover how to approach assay design for induced proximity and targeted protein degradation
    13:30 - 15:00 Anja Drescher and Mike Murphy Facilitating comparability with SPR-based surrogate potency assays and sensorgram comparison

    Cell therapy resources

    Regulatory: US preclinical study of cellular and gene therapies

    This free interactive course provides a high-level overview of preclinical study in cellular and gene therapy (CGT) development.

    Our location

    Testimonials