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PTSM: Pharmaceutical Technology Sourcing and Management-09-02-2015
PTSM: Pharmaceutical Technology Sourcing and Management
Technology Allows Automated Lab Reactor Control
August 28, 2015
Laboratory Instruments
11
9
Mettler Toledo’s RX-10 Reactor Control automates jacketed lab reactors and controls thermostats, stirrers, and pumps.
Flow Chemistry Systems Offer Options
August 28, 2015
Laboratory Instruments
11
9
Flow chemistry systems from Dolomite Microfluidics can be configured to suit different applications.
Spectrometers Comply with FDA Electronic Signature Regulation
August 28, 2015
In the Lab
11
9
Shimadzu Scientific Instruments reports its EDX-7000/8000 spectrometers are compliant with electronic signature regulations.
Pressure Reactor for Small Batch Reaction Chemistry
August 28, 2015
Laboratory Instruments
11
9
The SFT - HPR-Micro Reactor from Supercritical Fluid Technologies introduces a is a pressure reactor for small batch reaction chemistry.
Homogenizer Offers Continuous Operation
August 28, 2015
Laboratory Instruments
11
9
A high-pressure lab homogenizer from GEA for product development ensures efficiency and safety.
Mayne Pharma to Invest $65m in Manufacturing Expansion
August 28, 2015
Contract Services
11
9
Mayne Pharma plans to double oral-dose manufacturing space and expand contract services.
Next Step for Elemental Impurities
August 28, 2015
In the Lab
11
9
After a long wait for the new elemental impurities guidelines, the bio/pharma industry must now look ahead to implementation and take action.
Recipharm to Manufacture RedHill Biopharma’s FDC Therapy for Helicobacter pylori Infection
August 26, 2015
Contract Services
11
9
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.
WuXi PharmaTech Supplies Laboratory Testing Services to Lee's Pharm
August 26, 2015
Contract Services
11
9
WuXi's Laboratory Testing Division will be the exclusive supplier of laboratory testing services for Hong Kong-based Lee's Pharm.
Cytovance Biologics Acquired by Hepalink
August 25, 2015
Contract Services
11
9
Cytovance Biologics anticipates continued expansion plans following acquisition by Hepalink USA
Industry Responds to FDA Metrics Program
August 24, 2015
Regulatory
11
9
Manufacturers seek gradual rollout of more targeted FDA quality metrics program.
Mylan Receives FDA Warning Letter for Manufacturing Sites in India
August 19, 2015
Regulatory
11
9
Mylan received a warning letter citing violations at its Agila Specialty Formulation Facility, Sterile Products Division, and Onco Therapies Limited sites in India.
API Sourcing, Supply Chain Visibility, and Emerging Markets
August 19, 2015
Supply Chain
11
9
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.
Source BioScience Completes Acquisition of Select Pharma Laboratories
August 17, 2015
Contract Services
11
9
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.
Hermes Pharma Expands Formulation Services to US Market
August 13, 2015
Contract Services
11
9
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).
CMC Biologics to Manufacture mAbs for the Treatment of Malaria
August 13, 2015
Contract Services
11
9
CMC Biologics will manufacture monoclonal antibodies (mAbs) and provide process development services for the PATH Malaria Vaccine Initiative.
Catalent Biologics Announces New Advisory Board
August 12, 2015
Contract Services
11
9
Catalent selects advisory board members to complement Redwood Bioscience Scientific Advisory Board.
FDA Approves First 3D-Printed Drug Product
August 03, 2015
Regulatory
11
9
Aprecia Pharmaceutical’s SPRITAM levetiracetam gains FDA approval for the treatment of epilepsy.
FDA Issues Dissolution Testing Guidance
August 03, 2015
In the Lab
11
9
FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.
Pursuing Perfusion
August 02, 2015
API Synthesis and Manufacturing
11
9
Potential for improved product quality and cost/time savings is reviving interest in perfusion technology.
Cutting Costs and Cutting Jobs
August 02, 2015
Outsourcing
11
9
More contract service options encourage biopharma companies to cut costs by cutting jobs.