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Top Stories

Supreme Court Rules in Amgen v. Sandoz

The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.
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FDA Asks Endo to Remove Opioid From Market

FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing the potential for abuse.
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FDA Warns Utah Company for Repeated Quality Failures

Yusef Manufacturing Laboratories, LLC received an FDA warning letter citing CGMP violations at its Clearfield, UT facility.
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VIDEO

Plant Models in Biopharmaceutical Manufacturing
Barry Holtz, president, iBio CMO sat down with BioPharm International to discuss plant models in biopharmaceutical manufacturing.

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Industry News

2017 AAPS Slate of Candidates Announced

AAPS elections for Executive Council will be held in June/July 2017; results announced in August.
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New Project Seeks to Develop Novel Microfluidic Chip for Quick Formulation Stability Screening

The United Kingdom’s Center for Process Innovation (CPI) is investing in a new project, Microstar, which seeks to reduce risk for formulators through the development of accelerated screening methods for predictive design.
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Biopharma News

Lilly and KeyBioscience Join Forces on DACRAs

The companies will collaborate on the development of dual amylin calcitonin receptor agonists for patients with Type 2 diabetes.
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Novartis Releases Interim Analysis of CAR-T Therapy

The company released an interim analysis from its JULIET study with CTL019.
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Supplier News

UPS Opens New Healthcare Facility in Colombia

The new UPS facility in Colombia will serve the growing pharmaceutical, biopharma, and medical device industry in Latin America.
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AMRI to be Acquired by The Carlyle Group

The company will be acquired for $21.75 per share in cash.
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Regulatory News

EMA to Support Small and Medium-Sized Enterprises

The agency published an action plan to nurture innovation and drug development by SMEs.
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Efficient Manufacturing Critical for Accelerated Drug Development

Approval of breakthrough therapies requires expedited quality assessment.
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FEATURED TOPICS

MANUFACTURING

Unifying Continuous Biomanufacturing Operations

The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.
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UPSTREAM PROCESSING

N-Glycan Analysis of Biotherapeutic Proteins

This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products.
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DOWNSTREAM PROCESSING

Managing Residual Impurities During Downstream Processing

Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures.
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ANALYTICS

A Novel Metric for Continuous Improvement During Stage Three

How statistical methods and novel indices can be used to monitor and benchmark variability, to guide continuous improvement programs.
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Events

BIO International Convention

June 19–22, 2017

Advanced Therapy Medicinal Products

June 27–28, 2017

America Pharma Outsourcing Summit

September 27–28, 2017

more events

Reference Books

Quality by Design Vol. I & II

Quality by Design (QbD) compiles the best content from BioPharm International and Pharmaceutical Technology to provide valuable insight into the topic and assist in making the business case for QbD, based on the criteria decision makers need to evaluate new initiatives and related technology.
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More Reference Books

eBook

Outsourcing Resources 2017

Nearly 60% of the bio/pharma companies responding to a recent BioPharm International survey outsource at least half of their crucial development and manufacturing tasks. In this ebook, the editors report on the biopharma–contract services relationship.

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