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BioPharm International
November 06, 2018
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Top Stories

bioLIVE to Merge with BioProduction Congress for 2019 Event

Bioprocessing and manufacturing events bioLIVE and BioProduction Congress will take place as one event adjacent to CPhI Worldwide in Frankfurt, Germany, on November 5–7, 2019.
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Lonza Acquires a Controlling Stake in Octane Biotech for Cell Therapy Technology

The acquisition allows Lonza to further develop technology for scalable autologous cell-therapy manufacturing.
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Industry News

Fujifilm, CPI Collaborate on New Technologies for MAb Downstream Processing

Fujifilm Diosynth Biotechnologies and the Centre for Process Innovation (CPI) are collaborating to complete the technology transfer of the expression and purification of model monoclonal antibodies (mAbs) as part of AMECRYS, a research project funded by the European Commission.
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Cobra Biologics and the University of Leeds Collaborate on Viral Vector Bioprocessing

A project funded by BioProNET will investigate optimization for bioprocessing of gene therapy vectors using hydrodynamic fluid flow fields.
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Biopharma News

Mylan Launches Humira Biosimilar in Europe

Mylan announced the launch of its biosimilar to AbbVie’s Humira across major European markets.
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Biogen and Samsung Bioepis Launch Humira Biosimilar in Europe

The companies announced the European launch of Imraldi (adalimumab), a biosimilar referencing AbbVie's blockbuster Humira (adalimumab).
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Process Development Forum

Need to optimize your manufacturing systems? Find insights, solutions, and shortcuts in bioprocessing at ProcessDevelopmentForum.com.
Click here to access the site »


Supplier News

Thermo Fisher Scientific and Symphogen Collaborate to Develop Protein Analysis Workflows

Thermo Fisher Scientific has entered into a collaboration with Symphogen to deliver validated, platform workflows for simplified characterization and quality monitoring of complex therapeutic proteins.
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Charles River and Distributed Bio Partner on Integrated Antibody Platform

This new partnership provides access to Distributed Bio's antibody discovery platforms.
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IVT's 6th Annual Laboratory Week

IVT's 6th Lab Week conference series draws over 100 laboratory professionals and provides the value of three conferences in one, giving your team the ability to select sessions that best meet your business objectives. Hear from FDA and choose from over 25 workshops, think tanks, interactive presentations, case studies and educational courses surrounding analytical procedures and methods validation, stability testing and lab data integrity.
Learn More »


Regulatory News

FDA Announces Plan to Advance Biotech Innovation

A statement from FDA Commissioner Scott Gottlieb and Deputy Commissioner Anna Abram detailed FDA's new plan to advance plant and animal biotechnology innovation.
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Sandoz Gets FDA Approval for Humira Biosimilar

The company received FDA approval for Hyrimoz (adalimumab-adaz), its biosimilar referencing AbbVie’s blockbuster Humira (adalimumab).
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FEATURE TOPICS

MANUFACTURING

Using Nondestructive in-situ Measurements to Ensure Lyophilized Product Stability

Non-destructive surface area measurement can improve stability testing.
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DOWNSTREAM PROCESSING

Validating Virus Clearance in a Single-Use System Part 1: Film Adsorption and Virus Inactivation Studies

This article explores the use of single-use mixing technology in a detergent-based virus inactivation step during a monoclonal antibody production process.
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ANALYTICAL METHODS

AAPS Traces the Path to ICH M10

Efforts strive to harmonize bioanalytical method validation for non-clinical and clinical studies.
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REGULATORY

The Link Between Data Integrity and Quality Culture

Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.
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ON DEMAND WEBCASTS

Fast-Track Clone Selection and Cell Line Optimization Workflows: Automating Sample Prep to Screen Hundreds of N-Glycan Samples per Day
On Demand
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Timely, Accurate Analytical Purity Data Helps to Avoid Late Surprises When Scaling Up. Automated TEM Analysis Data of Gene Therapy Vectors and VLPs
On Demand
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Using High-Throughput Automation to Accelerate Biologic Drug Formulation
On Demand
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Rapid Automated Peptide Mapping
On Demand
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Protein A Chromatography: Important Features in Purification to Reduce mAb Aggregation and Increase Recovery
On Demand
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Bispecific Single-Domain Antibody Fused to Monoclonal Antibody (SMAB): The Natural Form
On Demand
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Make Better Decisions, Faster with Highly Reproducible, High-Throughput Glycan Screening
On Demand
Learn more


Events

ISPE Annual Meeting & Expo

November 4–7, 2018

Superbugs and Superdrugs USA

November 12–13, 2018

2018 ISPE Biopharmaceutical Manufacturing Conference

December 10–12, 2018

more events

eBook

Biopharma Laboratory Best Practices 2018 eBook

This eBook covers method development, analytical techniques, and profiles of new instruments, equipment, and supplies used in the testing and analysis of raw materials, drug substances, and drug products.

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