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BioPharm International
June 04, 2019
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Top Stories


Novartis' AveXis Prices Zolgensma Gene Therapy at $2+ Million, Offers Access Programs for US Payers and Families

The company says it will work with payers to create payment options for its recently approved gene therapy, Zolgensma (onasemnogene abeparvovec-xioi), priced at $2.125 million.
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New Compound Discovered that Kills Antibiotic-Resistant Microbes

Researchers at the University of Sheffield, Sheffield, UK, have discovered and developed a new compound that can kill antibiotic-resistant bacteria, including Escherichia coli.
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Industry News


GE Healthcare, World Courier Announce Supply Chain Collaboration

By connecting manufacturing processes and logistics technology, GE Healthcare and World Courier look to accelerate the development of advanced therapies.
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Opportunities and Challenges for Advancing Non-Prescription Medicines

FDA is supporting the development and marketing of OTC therapies, including CBD products, by proposing new rules and an expanded review office and promoting digital technologies.
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Biopharma News


Iovance Biotherapeutics Builds US Facility for Autologous Cell Therapy Products

A new facility to be built in the Philadelphia Navy Yard will support commercial production for autologous tumor-infiltrating lymphocyte cell therapy products from Iovance Biotherapeutics.
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Heritage Pharmaceuticals Inc. Recalls Products Due to Sterility Failure

The company is voluntarily recalling Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), to the consumer level because microbial growth was detected.
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Supplier News


Catalent Announces OneBio Suite

New offering from Catalent targets integrated development and manufacturing of biologic drugs.
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MilliporeSigma Announces North America Biotech Award Winners

MilliporeSigma awarded its Advance Biotech Grant to three US companies that are focused on traumatic brain injury, vaccine development, and chronic pain.
/ read more /


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Regulatory News


EMA Accepts Prestige BioPharma's Trastuzumab Biosimilar MAA for Review

Prestige BioPharma has announced that the EMA has accepted its marketing authorization application for HD201 (Tuzune) for review.
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FDA OKs Gene Therapy for Pediatric Spinal Muscular Atrophy

The agency has approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy to treat pediatric spinal muscular atrophy.
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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 »


FEATURED TOPICS

VIRAL CLEARANCE

Assessing Viral Inactivation for Continuous Processing

Testing demonstrates an automated semi-continuous process strategy for viral inactivation with steps that mimic batch processing.
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MANUFACTURING

Using the Multiple Attribute Method for Process Development and Quality Control

More manufacturers are embracing MAM, which simplifies biopharmaceutical product quality testing, and facilitates the measurement and monitoring of critical quality attributes.
/ read more /


FACILITY DESIGN AND ENGINEERING

Multi-Purpose Biopharmaceutical Manufacturing Facilities Part 1: Product Pipeline Manufacturing

A multi-purpose biopharmaceutical manufacturing facility using a matrix of multi-functional cleanrooms can be adapted to efficiently meet the capacity challenges of both supplying clinical trials and launching products.
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QUALITY CONTROL/QUALITY ASSURANCE

Simulating Reality in Mock Inspections

Mock inspections–if conducted properly–can prepare a pharma company for the day FDA knocks on the door.
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UPCOMING WEBCAST

Improving Confidence and Productivity in Released Glycan Analysis for Biotherapeutic Development
Wednesday, July 17, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Empowering HCP Identification with Antibody Affinity Extraction (AAE) and Mass Spectrometry
Tuesday, June 18, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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ON DEMAND WEBCAST

Transforming High Performance LC-MS Analysis in Biopharma: From Molecular Characterization to Attribute Monitoring
On Demand
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Events

ISPE Biopharmaceutical Manufacturing Conference

June 18–20, 2019

4th PDA Europe Annual Meeting

June 25–26, 2019

BioManufacturing Conference

September 3–4, 2019

more events

eBook

Outsourcing Resources 2019 eBook

Experts share insight and advice for conducting CMC due diligence with contract development organizations, using multiple attributes methods to monitor quality attributes, and strategies for using specialized services for biopharmaceutical development applications.

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