Upstream Bioprocessing
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Focus On Upstream
Maximize Your Molecule

Every stage of the upstream process presents an opportunity to maximize the speed and value of your molecule. EMD/Merck Millipore and Sigma-Aldrich have come together to provide a complete upstream foundation that helps you do both.

From cells to culture media and additives, to single-use biomanufacturing systems, biopharma materials for GMP-grade excipients and formulations additives, we offer a range of off-the-shelf and fully customized solutions.

Tap into an ecosystem of integrated upstream products and services from Merck

Cell Culture and Bioreactors
Ready to Integrate. Ready to Perform. Ready to Scale.

Our upstream portfolio includes cell lines, cell culture media, media supplements, buffers and bioreactors to ensure a robust biopharmaceutical manufacturing process that meets your yield and productivity targets.

Cell Line and Cell Culture

Performance and customization. The CHOZN® Platform offers a proven, integrated cGMP solution that jumpstarts cell-line development, accelerates scale-up and safeguards manufacturing.

Our exceptionally consistent fed-batch and perfusion media provide high-titer, high-quality and strict documentation standards. Utilize custom and off-the-shelf products from EX-CELL® Advanced and Cellvento™ that integrate seamlessly with the CHOZN® Platform and other cell lines.

Bioreactors

Mobius® Bioreactors offer a scalable portfolio of stirred tank solutions that provide flexible, single-use assemblies for suspension and adherent cell culture applications. Ranging from 3L to 2000L, our bioreactor platform has been designed to ensure ease of use in any phase of upstream processing—from preclinical to full-scale production.

Products and Services

CHOZN®
An off-the-shelf cell line platform for faster, simpler selection and scale up of high yielding clones.

EX-CELL Gal+®
A new protein quality supplement that targets glycosylation attributes.

EX-CELL® Advanced HD Perfusion Media
Specifically designed to meet next-generation processing requirements.

Cellvento™
A CHO platform that includes cell line and process-specific media and feed compositions.

imMEDIAte ADVANTAGE™
Custom, small-volume media services.

Mobius® Single-use Bioreactors
Scalable stirred tank bioreactors that provide flexibility for use in suspension and adherent cell culture applications.

Related Resources

[Perfusion: Infographic (next gen and perfusion)]
[Medicine Maker articles (3 on perfusion)]
[Bioreactor?]

Biosimilars Solutions
The Race for Biosimilars Demands Something Different

Featuring the CHOZN® Platform

In the push to market, the biosimilar that’s approved first wins the race. That’s why SAFC offers an off-the-shelf, customizable platform proven to accelerate cell line development timelines by 8 weeks. The CHOZN® Platform seamlessly integrates with cell culture media and feeds and offers a protein quality supplement that jumpstarts profile matching. In a competition where everyone is the same, the only thing that matters more than speed is expertise. See how the experts at SAFC can help you win the race to market.

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Related Links:

Related Resources:

Buffer and Media Prep
Buffer and Media Prep

Our biopharma materials product portfolio contains all the necessary single-ingredient raw materials to support biopharmaceutical manufacturing processes and requirements while delivering superior consistency, performance, safety and reliability. All products meet or exceed current regulatory and quality standards.

High-performance mixing of upstream ingredients is critical to improved biopharmaceutical manufacturing processes. Mobius® single-use MIX and Power MIX solutions deliver advanced technologies for combining intermediate and final pharmaceutical ingredients, as well as process solutions such as buffers and media.

We offer a complete range of GMP buffers for your upstream, purification and formulation steps with full traceability of our sourced raw materials to ensure the quality and consistency of your product.

[Call out] New Virus Barrier Filtration Launching in October: Suzanne will provide once ready

Related Links

Biopharmaceutical Materials
Complete upstream single-ingredient sourcing.

Mobius Mixing Systems
Mixing pharmaceutical ingredients from intermediate to final drug products.

Virus Barrier Filtration
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Related Resources

BPM

  • http://www.emdmillipore.com/US/en/product/Poloxamer-188-EMPROVE-EXPERT-cell-culture-optimized,MDA_CHEM-137097#documentation
  • https://www.slideshare.net/MilliporeSigma/predictable-protection-and-performance-with-poloxamer-188-emprove-expert-cell-culture-optimized?qid=a25afcd7-9a0f-48be-9401-7389fe74403c&v=&b=&from_search=2

Mobius Power MIX Scalability Mixing App Note

Virus Barrier Filtration???

Services
Service Solutions to Achieve Clinical Material in < 12 Months

EMPROVE®: The Emprove® Program supports your risk assessment and offers assistance in developing more robust processes. It also provides comprehensive and thorough documentation of our filters and single-use components as well as raw and starting pharma materials.

SERVICES: Expedite development using turnkey services:

  • Provantage® Process Development Services: Our services encompass the support and expertise you need to accelerate clinical drug development, scale your process and implement local production facilities globally.

  • BioReliance Bio Pharmaceutical Services (Biosafety Testing): A leading provider of contract services to the biopharmaceutical industry, supporting every phase of the testing, development and manufacturing process with a comprehensive and integrated suite of services.

    • Bulk Lot Release Testing: Our cGMP lot release testing services for bulk materials are in compliance with quality assurance and regulatory guidelines.
    • Product & Reference Standard Characterization: Used to determine the physicochemical profile of a drug substance or drug product in order to establish a standard for subsequent stages of testing.

Related Resources:

Provantage®
Webinar: Upstream Services to Fast-Track Manufacturing of Proteins
Brochure: Provantage End-to-End Services

EMPROVE

BioReliance
Biosafety Webinars for BioReliance, etc.
Provantage® Webinar

http://www.emdmillipore.com/US/en/services/biopharmaceutical-manufacturing/provantage-end-to-end-services/biopharm-process-development/h0Ob.qB.1e4AAAFUp8kGqsU1,nav

Single-use Systems
Single-Use Technologies

We partner with you throughout the process to select and implement single-use manufacturing products that help you work faster and more cost-effectively. From discovering single-use alternatives to optimizing your single-use unit operations, we provide the expertise and comprehensive solutions you need for bench-scale or full-scale production, including options for: buffer and media preparation, bioreactors, clarification, chromatography, virus clearance, ultrafiltration/diafiltration, formulation and fill.

Related Links

Related Resources

  • Globalization of Single Use: Medicine Maker
  • Integrated Bioprocessing Brochure
  • Brochure/Folder on Mobius® MyWay