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BioPharm International
April 16, 2019
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Top Stories


Bristol-Myers Squibb Shareholders Approve Celgene Acquisition

Shareholders have approved the issuance of Bristol-Myers Squibb common stock for the pending $74-billion merger with Celgene.
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Catalent to Acquire Paragon Bioservices for $1.2 Billion

Catalent’s acquisition of Paragon Bioservices will provide expertise in expanding gene therapy market.
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Industry News


CPhI North America Partners with iBIO to Foster Female Leadership in Biopharma

The partnership includes a $10,000 donation to fund Illinois Biotechnology Innovation Organization (iBIO) STEM programming for girls in grades three through eight.
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Thermo Fisher, Genovis Collaborate to Advance Characterization and Monitoring Methods

The companies will join forces on a research project to develop end-to-end workflows for the preparation, characterization, and monitoring of biotherapeutics using liquid chromatography-mass spectrometry.
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Biopharma News


Novartis Completes Alcon Eye-Care Spin-Off

With the spin-off, Alcon will operate as a standalone company, and Novartis will focus on its core innovative medicines.
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Pfizer, Concerto HealthAI Partner on Precision Oncology

Concerto HealthAI’s real-world data and artificial intelligence capabilities are expected to accelerate outcomes studies and patient insights for Pfizer’s investigational therapies and commercialized therapeutics.
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Supplier News


Precision NanoSystems Launches Clinical Solutions Service

The new service offers a flexible, customizable suite of products and services designed to accelerate the clinical and commercial development of gene and cell therapies.
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Legacy Pharmaceuticals, SCHOTT Collaborate to Solve Leaching Issue for AntiViral

Legacy Pharmaceuticals has entered into a collaboration with SCHOTT to solve a technical challenge of leaching that is occurring with an antiviral drug.
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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 »


Regulatory News


EMA on the Development of Novel Therapies

The European Medicines Agency (EMA) weighs in on the role of regulators in determining added benefits of novel therapies.
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Double, Double, Toil, and Trouble? The Brexit Cauldron May Bubble Away Until Halloween Under New Extension

Brexit has the potential to rumble on until Oct. 31, 2019 as the UK is granted a further six-month extension by European Union leaders.
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2019 BIO International Convention
June 3-6, 2019 | Philadelphia, PA
As the world's largest global biotechnology partnering event, the BIO International Convention (#BIO2019) is the one event where you can access 16,000+ attendees from 67 countries, network and set up meetings via BIO One-on-One Partnering™, and attend 150+ education sessions. Discover the next generation of cutting-edge products, therapies, and cures all week long.
Learn More »


FEATURED TOPICS

BIOPHARMACEUTICAL ANALYSIS

Cleaning Chromatography Resin Residues from Surfaces

Laboratory test methods evaluate cleaning agents and cleaning process design for removing resin residues from the surfaces of non-dedicated chromatography columns systems.
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DOWNSTREAM PROCESSING

What’s New in Downstream Processing

The latest advances in downstream processing include remote monitoring, membrane chromatography technology, single-use sensors, and new uses of data analytics.
/ read more /


DRUG DEVELOPMENT

Where Automation Meets Skill Set

A look at the skill sets and training needed to tackle the increasing levels of automation in bioprocessing facilities.
/ read more /

REGULATORY BEAT

Continuous Manufacturing Gains Major Push from FDA

FDA is moving to shift industry away from step-wise batch production.
/ read more /


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Register for the free live webcast “Sustainable Sourcing and Supply Chain Engagement in Pharma.”
Various aspects of the pharma sourcing process and supplier relationships offer opportunities to advance sustainability and strategic goals. These include alternative raw materials at manufacturing facilities (e.g., biomass and recycled plastic), sourcing of renewable materials (e.g., palm oil), partnering on supplier sustainability, and more. This May 7 event is sponsored by BASF, Sustainable Brands, and Pharmaceutical Technology.
Register Now »


CPhI NORTH AMERICA 2019 EXHIBITOR GUIDE

Accelerate. Scale. Implement.

BioReliance® End-to-End Solutions encompass service and support for both emerging biotech as well as major biopharmaceutical companies that seek to accelerate process development, clinical drug production, and conceptual facilities design.
/ read more /


Patheon

Thermo Fisher Scientific provides end-to-end development and manufacturing solutions to customers of all sizes through Patheon and Fisher Clinical Services, which deliver pharma services and clinical trials services.
/ read more /

USP

USP’s Ingredient Verification Program for Excipients includes a complete evaluation of your quality system.
/ read more /

 

NEW PRODUCTS AND SERVICES


Distek, Inc.

Distek, a manufacturer of laboratory testing instruments for the pharmaceutical and biotechnology industry, has added a dual impeller single-use bioreactor system to its BIOne portfolio.
/ read more /


UPCOMING WEBCASTS

Characterizing CQAs of Biopharmaceutical Products: A Comprehensive Workflow Approach to Common Biopharmaceutical Tests
US and Europe: Wednesday, April 24, 2019 at 9am EDT | 2pm BST | 3pm CEST
US: Wednesday, April 24, 2019 at 2pm EDT | 1pm CDT | 11am PDT
Asia-Pacific: Thursday, April 25, 2019 at 8:30am IST | 11am CST | 12pm JST
Register Now


Approaches to Analyze and Understand 1–100 µm Particles/Aggregates in Biotherapeutics
Tuesday, April 23, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register Now


Direct Identification of Contaminant Particles on Lyophilization Cakes
Thursday, April 18, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register Now


Approaches to mAb Charge Variant Characterization using On-Line CEX-MS and Off-Line Analysis of CEX Purified Variants
Wednesday, April 17, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register Now


ON DEMAND WEBCAST

Meaningful Analytics Data for Quick Decision Making in Development of Viral Vector-Based Therapies
On Demand
Learn more


Sample Preparation and Analysis Workflows for Released N-Glycan Analysis of Biotherapeutics
On Demand
Learn more


Events

World Vaccine Congress

April 14–17, 2019

CPhI North America

April 30–May 2, 2019

Injectable Drug Delivery 2019

May 15–16, 2019

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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