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BioPharm International
February 20, 2018
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Top Stories

FDA Gets Boost from New Budget Plan

The Trump budget boosts funding for FDA but squeezes resources for NIH and healthcare.
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Charles River Laboratories Acquires MPI Research

A $800-million acquisition of MPI Research expands Charles River's offerings for early-stage contract research.
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Industry News

BIO Publishes Report on Pain Meds

A new report states that more research and clinical development must be done in the treatment of pain and addiction.
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Drug-Delivering Capsules Support Transplanted Insulin-Producing Cells

Researchers at the University of Illinois developed a method to transplant pancreatic islet cells from pigs more easily to treat type I diabetes.
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Process Development Forum
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Biopharma News

Ferring to Invest in New Biotech Center

Ferring Pharmaceuticals will expand its biologics capabilities at its headquarters and manufacturing site in Saint-Prex, Switzerland.
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Fujifilm, Takeda Partner on Regenerative Medicine Therapies

The companies will work together on developing regenerative medicine therapies for heart failure.
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Regulatory News

Poor Aseptic Practices Found at Korean Facility

FDA sent a warning letter to Celltrion detailing CGMP violations, including poor microbial contamination control.
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FDA Approves New Treatment for Prostate Cancer

The agency has approved a new treatment for a certain type of prostate cancer using novel clinical trial endpoint.
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Supplier News

ADC Bio to Develop New Bioconjugation Process

Unlike current approaches where bioconjugation is typically done following the manufacture of the monoclonal antibody and the cytotoxic drug, the new method begins with the antibody supernatants and eliminates the need for extensive chromatographic purification.
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Cobra Biologics, Symbiosis Awarded Innovate UK Grant

The companies have been awarded a collaborative grant of £1.9 million (US$2.6 million) from Innovate UK.
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FEATURED TOPICS

BIOPHARMACEUTICAL ANALYSIS

Maintaining Lab Data Integrity

This article explores lab data integrity violation trends, as well as a sampling of the latest technologies that can help avoid them.
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MANUFACTURING

Container Closures: Leaving Nothing to Chance

As closure integrity testing moves from a probabilistic to a deterministic basis, designs are promoting improved control and reduced operator contact.
/ read more /


GMPs

Applying GMPs in Stages of Development

Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, according to Susan Schniepp, fellow at Regulatory Compliance Associates.
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QUALITY SYSTEMS

Preclinical Evaluation of Product Related Impurities and Variants

The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the shortcoming with the contemporary approaches.
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Events

Pittcon 2018

February 26–March 1, 2018

9th Global Drug Delivery & Formulation Summit

March 12–14, 2018

Paperless Lab Academy 2018

March 20–21, 2018

more events

eBook

Vaccines Development and Manufacturing 2017 eBook

Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible.

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