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Articles

Advanced data analytics, including statistical modeling and machine learning technique, can enable more efficient and reliable bioprocesses.

Understanding Commercial Cell Culture Process Performance Variation Through Advanced Data Analytics

This study aims to use plant-leaf extract for the green synthesis of gold nanoparticles and to evaluate their antibacterial and antioxidant activity.

Therapeutic Potential of Green, Synthesized Gold Nanoparticles

In this study, a novel aldo-keto reductase was cloned and purified, and its important conserved sites were analyzed.

Catalytic Site Analysis and Characterization of a Solvent-Tolerant Aldo-Keto Reductase

Harry Silver is senior process/facility designer at Harry Silver Designs.

Mark Witcher is a consultant, witchermf@aol.com

The authors present a risk analysis of the impact of various business and operating risks on three facility layout strategies.

Comparing Facility Layout Options for Managing Business and Operating Risks

Karen Chan is a staff engineer at MilliporeSigma.

Torsten Bisschop is a biomanufacturing engineer consultant at MilliporeSigma.

Herb Lutz is a principal consultant at MilliporeSigma.

A key technology that can help achieve a continuous production flow is single-pass tangential flow filtration.

Efficacy of a Simple Static Cleaning Procedure for SPTFF

This research proposes a method for separating and purifying tissue-type plasminogen activator from a fungal cell source.

Separation and Purification of a Tissue-Type Plasminogen Activator from Trichoderma reesei

Dr. FranÃ§ois Coutard was bioengineering unit manager at the Bioengineering unit, LFB Biomanufacturing.

Dr. Nick Hutchinson was technical content marketing manager at Sartorius Stedim Biotech.

Eve DePauw is downstream process technician at the Bioengineering unit, LFB Biomanufacturing.

Ronan McCarthy is senior downstream process scientist at the Bioengineering unit, LFB Biomanufacturing.

Ludovic Bouchez is downstream process technician at the Bioengineering unit, LFB Biomanufacturing.

Dr. Isabelle Uettwiller is head of validation lab, Confidence Validation Service at Sartorius Stedim Biotech.

AmÃ©lie Boulais is process development consultant, Integrated Solutions Marketing at Sartorius Stedim Biotech.

The second half of this article describes the testing methods used by the authors to demonstrate the applicability of single-use mixing technology for virus inactivation.

Single-Use Mixing Technology for Virus Clearance (Part 2: Compatibility, Leachables, and Scale-Up Studies)

Martin Wisher, PHD, is senior director, global head of regulatory affairs for BioReliance at MilliporeSigma.

Anissa Boumlic, PHD, is associate director EMEA vaccine and viral therapies, MilliporeSigma.

Damon Asher, PHD, is associate director Americas vaccine and viral therapies, MilliporeSigma.

Priyabrata Pattnaik, PHD, is head of biologics operations-Asia Pacific, MilliporeSigma.

Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.

Ensuring Viral Safety of Viral Vaccines and Vectors

Makoto Sadamitsu is a principal scientist at Biopharmaceuticals Process and Product Development, Pharmaceutical Sciences, Takeda Pharmaceutical.

Shunsuke Omori is scientist at Biopharmaceuticals Process and Product Development, Pharmaceutical Sciences, Takeda Pharmaceutical.

Tetsuya Ohta is a principal scientist at Biopharmaceuticals Process and Product Development, Pharmaceutical Sciences, Takeda Pharmaceutical.

Shinji Tsuji is associate director at Biopharmaceuticals Process and Product Development, Pharmaceutical Sciences, Takeda Pharmaceutical.

This study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk.
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Study on an Inactivation Evaluation Method of Cleaning Processes for Biopharmaceuticals

The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance measurements for use with the new generation of microvolume spectrophotometers and short-pathlength cuvettes.

Peer-Reviewed Research