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BioPharm International
October 8, 2019
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Top Stories


Bayer, Arvinas Launch Joint Venture for Targeted Protein Degradation Products

The new joint venture, named Oerth Bio, will use Arvinas’ Protac technology to develop innovative new agricultural products. As part of its collaboration with Arvinas, Bayer is also using this technology to develop human therapeutics
/ read more /


GSK Invests $120 million in US Biopharmaceutical Manufacturing Facility

GSK’s expanded R&D and manufacturing facility in Upper Merion, PA houses a new analytical lab and flexible manufacturing equipment, including single-use bioreactors.
/ read more /

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Industry News


Novartis Collaborates with Microsoft for AI
Innovation Lab

The companies agreed to a multi-year research and development collaboration that will focus on AI empowerment and exploration.
/ read more /


Regen Shows Positive Data for CBD Arthritis Treatment

Data showed that the drug candidate activated T regulatory cells, believed to serve a crucial role in protecting the body from uncontrolled inflammation or autoimmunity.
/ read more /


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Biopharma N-Glycan Analysis Resource Center
An online resource with useful tools and practical information to find out more about Biopharma N-Glycan Analysis. The site provides useful webcasts, videos, application notes, posters, and more from leading practitioners in the field of chromatography.
Learn More »


Biopharma News


GSK Completes Retrofit of Maryland Facility

GSK invested $139 million to its Rockville, MD site to support demand for Benlysta.
/ read more /


Astellas Invests $13 Million into Innovation
Facilities for Cell and Gene Therapy

The new incubators are set to be operational starting in 2021.
/ read more /


More Biopharma News

Supplier News


Lonza Enters Manufacturing Agreement with
Cellectis for CAR T Cell Development

Manufacturing of the cell line will take place at Lonza’s GMP facility in Geleen, Netherlands.
/ read more /


TrakCel Forms Cell and Gene Therapy Supply Partnership with WuXi AppTec

The partnership combines global CDMO services with a cellular orchestration platform.
/ read more /


More Supplier News


Regulatory News


FDA Releases New Bioanalytical Methods Tables for New Drug and Biologic Applications

The tables can be used for new drug applications, biologics license applications, and supplements to these applications
/ read more /



FDA Approves New Drug to Prevent HIV Infection

The agency has approved Gilead Sciences’ Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for reducing the risk of HIV-1 infection.
/ read more /


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FEATURED TOPICS

MANUFACTURING

Overcoming Challenges in ADC Bioconjugation at Commercial Scale

Bioconjugation requires aseptic manufacturing and containment for cytotoxic payloads.
/ read more /

 

ANALYTICAL METHODS

Managing Biologic Equipment Cleaning

This article takes a look at current practices for cleaning and sterilizing biomanufacturing equipment used in a multi-product versus single-product setting.
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BUSINESS TRENDS

Caught in a Conundrum

Do patients get what they pay for when they demand cheaper drugs?
/ read more /

DOWNSTREAM PROCESSING

Efficacy of a Simple Static Cleaning Procedure for SPTFF

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


UPCOMING WEBCASTS

Innovative and Effective Workflow Solutions for Oligonucleotides from Purification to Analysis
Tuesday, October 22, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Rapid Low-level Identification and Quantitation of Host Cell Proteins
Europe: Thursday, October 10, 2019 at 2pm BST | 3pm CEST
North America: Thursday, October 10, 2019 2pm EDT | 1pm CDT | 11am PDT
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USP General Chapter <1049.1> Design of Stability Studies for Biotechnology Product Development and Lifecycle Management
Wednesday, October 9, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Digging Deeper in Every Direction: Developing a Next-Generation Platform for High-Throughput Multi-Faceted Protein Characterization
Thursday, October 3, 2019 at 11am EDT | 8am EDT | 4pm BST | 5pm CEST
Register Now

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On Demand WEBCASTS


Expanded Capabilities for Bioanalysis Leveraging a Chromatography Data System
On Demand
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How Artificial Intelligence Can Address Analytical Challenges in Gene Therapies and Vaccines
On Demand
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Understanding Biotherapeutic Product Quality Attributes through a Multi-Attribute Method (MAM) Lab-of-the-Future
On Demand
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From Small-Scale Stem Cell Production to Large-Scale hiPSC-Based Drug Development: The Flexibility of Stirred-Tank Bioreactors
On Demand
Learn More


Developing a Robust CQA Monitoring Method via Multi-Attribute Monitoring Principles for Therapeutic Monoclonal Antibody Development, Manufacturing, and Lifecycle Management
On Demand
Learn More

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Events

IVT's 25th Annual Validation Week

October 16, 2019

ISPE Annual Meeting & Expo

October 27–November 1, 2019

AAPS PharmSci 360

November 3–6, 2019

more events

eBook

Single-Use Systems 2019 eBook

The editors examine the technology, practices, and regulatory approval questions facing companies employing single-use technologies for commercial manufacturing.

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