September 2015, Volume 11 Issue 9
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In the Lab
The bio/pharma industry looks ahead to implementation strategies for the new elemental impurities guidelines.
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FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.
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Laboratory Instruments
The SFT - HPR-Micro Reactor from Supercritical Fluid Technologies introduces a is a pressure reactor for small batch reaction chemistry.
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A high-pressure lab homogenizer from GEA for product development ensures efficiency and safety.
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Mettler Toledo's RX-10 Reactor Control automates jacketed lab reactors and controls thermostats, stirrers, and pumps.
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Flow chemistry systems from Dolomite Microfluidics can be configured to suit different applications.
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Shimadzu Scientific Instruments reports its EDX-7000/8000 spectrometers are compliant with electronic signature regulations.
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API Synthesis & Manufacturing
Perfusion technology’s benefits of improved product quality and cost/time savings is stimulating interest in the process.
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Regulation & Compliance
Manufacturers seek gradual rollout of more targeted FDA quality metrics program.
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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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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.
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Supply Chain
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
More contract service options encourage biopharma companies to cut costs by cutting jobs.
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Contract Services
Mayne Pharma plans to double oral-dose manufacturing space and expand contract services.
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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'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 anticipates continued expansion plans following acquisition by Hepalink USA.
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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 will manufacture monoclonal antibodies (mAbs) and provide process development services for the PATH Malaria Vaccine Initiative.
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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 selects advisory board members to complement Redwood Bioscience Scientific Advisory Board.
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