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BioPharm International
October 29, 2019
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Top Stories


Sartorius Acquires Danaher Life Science
Businesses for $750 million

The transaction is set to be completed in the first quarter of 2020.
/ read more /


GSK Divests Vaccines to Bavarian Nordic for up to $1.1 Billion

The transaction is anticipated to close by the end of 2019.
/ read more /

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Industry News


GE Healthcare, CPI, and Cobra Biologics
Introduce New AAV Purification System

The partners have developed a scalable, cost-effective purification process for adeno-associated viruses.
/ read more /


NIH and Bill & Melinda Gates Foundation to Invest $200 Million into Sickle Cell Disease and HIV Gene-Based Cures

The goal of the investment is for the cures to be made available across the globe, including in sub-Saharan Africa’s low-resource communities.
/ 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


Takeda Acquires Global License for Celiac
Disease Therapy for $420 million

The therapy received positive results in a randomized, double-blind, placebo-controlled clinical trial in 34 adults with proven celiac disease.
/ read more /



First Ebola Vaccine Gains Conditional Marketing Authorization Recommendation

CHMP has recommended that Ervebo (rVSVΔG-ZEBOV-GP), a vaccine for active immunization against Ebola, be granted conditional marketing authorization in the EU.
/ read more /


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Supplier News


BioInvent Enters into Production Agreement
Expected to Generate $30 million

The company will produce the anti-HER3 antibody drug HMBD-001for use within a clinical partnership between Cancer Research UK and Hummingbird Bioscience to test the agent in a Phase I trial.
/ read more /



Aldveron and Nature Technology Corporation Collaborate to Offer Gene Therapy Services

Under the agreement, gene and cell therapy companies can go directly to Aldevron for NTC’s technology without acquiring a license from NTC.
/ read more /


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Regulatory News


FDA Publishes Guidance on User Fees

The guidance discuses waivers, refunds, and reductions of user fees under sections 735 and 736 of the FD&C Act.
/ read more /




FDA Publishes Drug Master File Guidance

The guidance document discusses the preparation and submitting of drug master files as well as FDA’s review process.
/ read more /


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FEATURED TOPICS

MANUFACTURING

Technology Redefines Continuous Processing Efficiency

Used with perfusion, alternating tangential flow and tangential flow filtration are redefining upstream efficiency.
/ read more /

 

REGULATORY BEAT

Data Integrity Violations Draw Strong FDA Rebukes

Falsified documents and manipulated test results prompt warnings and investigations.
/ read more /


ANALYTICS

Stability Indicating Methods for Aluminum
Adsorbed Vaccine Products

The authors provide an introduction to aluminum adsorbed vaccines, review studies of antigen stability, and propose test methods for the analysis of aluminum vaccine release and stability analysis.
/ read more /

DOWNSTREAM PROCESSING

Using Software in Process Validation

Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction.
/ read more /


UPCOMING WEBCASTS

Multi-Column Continuous Chromatography for Process-Intensified Capture and Polishing of Monoclonal Antibodies
Tuesday, November 19, 2019 at 11am EST | 8am PST | 4pm GMT | 5pm CET
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Assays to Evaluate Fragment Crystallizable (Fc)-Mediated Effector Function
Friday, November 1, 2019 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET
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Choosing The Right CDMO For Late-Phase Clinical Trials
Wednesday, October 30, 2019 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET
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New Research Revealed on a Promising Functional Alternative to Surfactants within Biologic Formulations
Tuesday October 29, 2019 at 10am EDT | 9am CDT | 2pm GMT | 3pm CET
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On Demand WEBCASTS


Reach the Ultimate Level of Data Integrity
On Demand
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Innovative and Effective Workflow Solutions for Oligonucleotides from Purification to Analysis
On Demand
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Rapid Low-level Identification and Quantitation of Host Cell Proteins
On Demand
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USP General Chapter <1049.1> Design of Stability Studies for Biotechnology Product Development and Lifecycle Management
On Demand
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Digging Deeper in Every Direction: Developing a Next-Generation Platform for High-Throughput Multi-Faceted Protein Characterization
On Demand
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Events

AAPS PharmSci 360

November 3-6, 2019

CPhI Worldwide

November 5-7, 2019

Twin Screw Workshop

December 4–5, 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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