Pharmaceutical Technology Sourcing and Management Monthly Issue:
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Pharm Tech
September 2015, Volume 11 Issue 9
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In This Issue

Regulation & Compliance
Supply Chain
Outsourcing Update

In the Lab

Next Step for Elemental Impurities

The bio/pharma industry looks ahead to implementation strategies for the new elemental impurities guidelines.
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FDA Issues Dissolution Testing Guidance

FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.
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Laboratory Instruments

Pressure Reactor for Small Batch Reaction Chemistry

The SFT - HPR-Micro Reactor from Supercritical Fluid Technologies introduces a is a pressure reactor for small batch reaction chemistry.
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Homogenizer Offers Continuous Operation

A high-pressure lab homogenizer from GEA for product development ensures efficiency and safety.
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Technology Allows Automated Lab Reactor Control

Mettler Toledo's RX-10 Reactor Control automates jacketed lab reactors and controls thermostats, stirrers, and pumps.
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Flow Chemistry Systems Offer Options

Flow chemistry systems from Dolomite Microfluidics can be configured to suit different applications.
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Spectrometers Comply with FDA Electronic Signature Regulation

Shimadzu Scientific Instruments reports its EDX-7000/8000 spectrometers are compliant with electronic signature regulations.
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API Synthesis & Manufacturing

Pursuing Perfusion

Perfusion technology’s benefits of improved product quality and cost/time savings is stimulating interest in the process.
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Regulation & Compliance

Industry Responds to FDA Metrics Program

Manufacturers seek gradual rollout of more targeted FDA quality metrics program.
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Mylan Receives FDA Warning Letter for Manufacturing Sites in India

Mylan received an FDA warning letter citing violations at its Agila Specialty Formulation Facility, Sterile Products Division, and Onco Therapies Limited sites in India.
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FDA Approves First 3D-Printed Drug Product

Aprecia Pharmaceutical’s SPRITAM levetiracetam gains FDA approval for the treatment of epilepsy.
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Solubility Enhancement
Solutions Using Predictive Analytics & Molecular Modeling

On Demand
Learn about a novel, systematic methodology to accelerate solubilization of poorly soluble molecules and speed formulation optimization and process development. Understand how molecular modeling can be used enhance the predictability of solubilization and overcome poor bioavailability.
Learn more



Supply Chain

API Sourcing, Supply Chain Visibility, and Emerging Markets

Kate Kuhrt, senior director, Generics and Biotech, Thomson Reuters, spoke with Pharmaceutical Technology Europe about sourcing trends, supply chain challenges, the emerging market outlook, and how it affects European pharmaceutical manufacturers.
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Outsourcing

Cutting Costs and Cutting Jobs

More contract service options encourage biopharma companies to cut costs by cutting jobs.
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Innovative Tools for the Development and Manufacturing of Biotherapeutic Proteins
On Demand
The biopharmaceutical industry has seen ever increasing innovation over the past five years. Most notably, there has been an increase adoption of high-throughput process development (HTPD) and single-use technologies. Join our webinar to learn effective strategies to match product quality attributes for a biosimilar product and reduce process development timelines.
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Contract Services

Mayne Pharma to Invest $65m in Manufacturing Expansion

Mayne Pharma plans to double oral-dose manufacturing space and expand contract services.
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Recipharm to Manufacture RedHill Biopharma’s FDC Therapy for Helicobacter pylori Infection

Recipharm will be responsible for the supply of the remaining clinical-trial material and ongoing future commercial supply of RHB-105, the lead drug candidate developed by RedHill for the treatment of Helicobacter pylori bacterial infection.
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WuXi PharmaTech Supplies Laboratory Testing Services to Lee's Pharm

WuXi's Laboratory Testing Division will be the exclusive supplier of laboratory testing services for Hong Kong-based Lee's Pharm.
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Cytovance Biologics Acquired by Hepalink

Cytovance Biologics anticipates continued expansion plans following acquisition by Hepalink USA.
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Source BioScience Completes Acquisition of Select Pharma Laboratories

With this acquisition, Source BioScience is now able to offer integrated solutions to customers, with environmentally controlled storage in combination with the required up- or downstream analytical testing services.
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CMC Biologics to Manufacture mAbs for the Treatment of Malaria

CMC Biologics will manufacture monoclonal antibodies (mAbs) and provide process development services for the PATH Malaria Vaccine Initiative.
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Hermes Pharma Expands Formulation Services to US Market

Companies in the US will now have the opportunity to tap into Hermes Pharma’s technical expertise in effervescent and chewable tablets, instant drinks, lozenges, and orally disintegrating granules (ODGs).
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Catalent Biologics Announces New Advisory Board

Catalent selects advisory board members to complement Redwood Bioscience Scientific Advisory Board.
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