Optimize your Downstream Operations
new products
DENARASE endonuclease
Manual benchtop Crossflow system
Miniaturized Scalable Membrane Adsorber
Maximize your Virus Filter
eKnowledge base
Challenges and Trends
in Vaccine Manufacturing
Key Considerations for Development and Production of Vaccine Products
The Need for Innovation in Biomanufacturing
application notes
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book review
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mark your calendars!
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Dr. Uwe GottschalkToday's biopharmaceutical processes rely on innovative concepts and technologies to manage challenges in a commercial environment that simultaneously demands higher productivity, robust quality, and lower costs. Although biomanufacturing has become generic, robust, streamlined and efficient in general, the productivity gap between up- and downstream processing is widening and purification processes are still regarded as too complex.

Sartorius Stedim Biotech is devoted to providing solutions that contribute to efficiency and flexibility while also debottlenecking biomanufacturing operations.

With this newsletter we highlight innovative products tailormade for downstream operations focussing on the removal of process contaminants such as DNA, host cell proteins, viruses and - often overlooked - water. Information on recent publications and upcoming meetings are included and we hope that this compendium is appreciated by the end-user in the pharma-/biotech industry.

Any feedback on our services are welcome whether via email, phone or personally.

With best regards,
Dr. Uwe Gottschalk
DENARASE endonuclease
Optimize the recovery of your target molecules

Do your samples have high DNA concentrations? Are the recovery rates for your product often low?
Sartorius DENARASE will help to improve your overall yield and protect downstream membranes and columns. It reduces the DNA content at an early stage of your process to prevent interfering interactions with your target molecule.

» Learn more
Your best assistant in ultra- and diafiltration

This manual benchtop Crossflow system has been optimized for ultrafiltration, microfiltration and diafiltration applications used in many downstream processes. The system is suitable for flexible use in laboratory environments for process development and clinical trials as well as for small-scale production batches.

» Learn more
» Animation Crossflow Cassette functionality
Reduce sample usage with Sartobind® pico
Membrane chromatography tool for process development

Would you like to reduce consumption of your valuable material during testing & early development? The Sartobind® pico device has been designed to minimize sample usage. With a membrane volume of 0.08 ml, it is the smallest member of the scalable Sartobind® family featuring nano, mini, 5”, 10”, 20”, 30” and mega capsules.

» Learn more
» Brochure
Virosart® Max
Maximize your virus filter performance by adsorptive pre-filtration

Virus filter performance can be significantly increased with optimized adsorptive pre-filtration.
Virosart® Max combines size exclusion mechanism with efficient adsorptive capacities to increase the robustness of the following virus filtration step. As a result, Virosart® Max ensures highest protection of your final virus-retentive membrane, significantly increasing its robustness and capacity.

» Learn more about Virosart®
Challenges and Trends
in Vaccine Manufacturing

An evaluation of the technologies needed to develop a safe, effective, and economically efficient vaccine. This article is part of a special section on vaccines.

Oct 2, 2011
By: Suma Ray, PhD
BioPharm International Supplements
Volume 24, Issue 10, pp. s3-s11

» Read full article
Key Considerations for Development and Production of Vaccine Products
Challenges of vaccine development include regulatory, technical, and manufacturing hurdles in translating a vaccine candidate into a commercial product.

Mar 2, 2012
By: Anurag S. Rathore, Suresh Jadhav, Mahesh Bhalghat, Shiraz Kandawalla, Suma Ray, PhD, Ashok Kumar Patra
BioPharm International Supplements
Volume 25, Issue 3, pp. s28-s34

» Read full article
The Need for Innovation in Biomanufacturing

pp. 489 - 492
Uwe Gottschalk, Kurt Brorson & Abhinav A Shukla
nature biotechnology
June 2012, Volume 30
No 6 pp. 469-566

» Access to article
Application Notes
Concentration and Diafiltration of Tetanus Vaccine
Hydrosart® 0.2 μm MF | Hydrosart® 30kD UF

Concentration of Diphtheria vaccine in downstream processing
Hydrosart® 10kD

Scale up with Sartobind® Q pico
Miniaturized scalable format for process developers

Host cell protein removal with Sartobind STIC® PA pico
Performance of salt tolerant anion exchanger in a miniaturized capsule format
Pharmaceutical Biotechnology

Drug Discovery and Clinical Applications
Kayser, Oliver / Warzecha, Heribert (eds.)

This second edition of this successful book is greatly expanded and completely revised. It focuses on industrial pharmaceutical research and covers biotechnology fundamentals as well as all aspects of drug, diagnostics and vaccine development.

Please refer to chapter eight “Downstream Processing”, pp. 179-199, by Uwe Gottschalk.

2., completely revised Edition - April 2012
269.- Euro
2012. XXVIII, 648 Pages, Hardcover
78 Fig. (14 Colored Fig.), 50 Tab.
- Handbook/Reference Book -
ISBN-10: 3-527-32994-3
ISBN-13: 978-3-527-32994-6 - Wiley-VCH, Weinheim

» more
Process Validation in Manufacturing of Biopharmaceuticals

Third Edition
Edited by Anurag S. Rathore, Gail Sofer

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes.

Please refer to Chapter 14 “Process Validation in Membrane Chromatography”, pp. 385-410, by Suma Ray and Miyako Hirai.

Hardback, 531 Pages: 978-1-43-985093-0: £108.00
Third Edition; Published 10th May 2012 by CRC Press, Taylor & Francis Group

» more
Peace of mind with triple-A polishing technologies
UVivatec® virus inactivation, Sartobind® membrane chromatography and Virosart® filtration represent today's spearheading technologies for quantitative virus and contaminant clearance. Together they form a unique orthogonal platform for state of the art polishing of biopharmaceuticals.

» Learn more
Crossflow Solutions from Lab- to Process-Scale
Sartorius Stedim Biotech is a total solution provider and an expert in single-use technologies, offering extensive engineering know-how and capabilities.

» Learn more
Mark your calendars!
8th European Downstream Technology Forum 2012

This forum has been initiated to discuss a modern, integrated approach in downstream processing. During the last years, hundreds of experts from industry and academia have accepted the invitation to exchange ideas and share their experience.

Expanding upon these successful meetings, we would like to cordially invite you to attend our Downstream Technology Forum 2012. The conference has been designed for individuals from R&D, manufacturing, process engineering, quality assurance and compliance who have an interest in innovative technologies for biopharmaceutical processes.

8th European Downstream Technology Forum
September 11-12, 2012,
Sartorius College,
Goettingen, Germany
» Further information
» Registration

Downstream Technology Forum Cambridge
September 26, 2012,
Boston Marriott Cambridge
Cambridge, MA
» Further information
» Registration
Visit us at the Achema
June 18 – 22, 2012
Frankfurt am Main, Germany
Outdoor Area F1.0, Booth A17

We look forward to welcoming you at our booth. There you will find our latest products and solutions.
For more information, please click here.

Viral Safety for Biologics
June 27 – 28, 2012
Hotel Pullman Cologne, Cologne, Germany

Special VIP discount of 25% as a valued Sartorius Stedim Biotech customer. Just use your VIP Code “CQ3471SARTORIUS” when you register to attend. We look forward to welcoming you to this event and to seeing you at our booth.
» click here

Further Sartorius events
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Fax +49.551.308-3289
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Dr. Joachim Kreuzburg, Chairman
Jörg Pfirrmann, Reinhard Vogt

Chairman of the Supervisory Board
Prof. Dr. Dres. h.c. Arnold Picot, Gauting
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