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PTSM: Pharmaceutical Technology Sourcing and Management-07-01-2015
PTSM: Pharmaceutical Technology Sourcing and Management
SGS Completes New Labs at Shanghai Facility
June 26, 2015
Contract Services
11
7
SGS Life Science Services expands cGMP chemistry and biotechnology testing facilities in Shanghai.
American Airlines Cargo Opens Philadelphia Facility
June 26, 2015
Supply Chain
11
7
A 25,000-sq-ft cargo facility at Philadelphia International Airport offers different levels of temperature storage.
Assay Testing Shifts to Outsourced Operations
June 26, 2015
Outsourcing
11
7
More biopharma companies choose outside service providers for assay testing.
New Ways Around Hazardous Reagent Chemistry
June 26, 2015
API Synthesis and Manufacturing
11
7
Safer reagents and reaction conditions are making many hazardous transformations possible.
Making Manufacturing Modernization Easier
June 26, 2015
Regulation and Compliance
11
7
Regulators and industry seek to streamline and harmonize oversight of manufacturing changes for firms that adopt modern production methods.
GS1 US Appoints Greg Bylo Vice-President of Healthcare
June 26, 2015
Supply Chain
11
7
Bylo has been selected to lead the GS1 Healthcare US Industry Initiative, focused on driving adoption and usage of GS1 Standards in healthcare.
EMVO Names Service Providers for FMD Project
June 25, 2015
Supply Chain
11
7
The European Medicines Verification Organization has signed agreements with service providers to establish blueprint systems in compliance with the Falsified Medicines Directive.
Novasep Plans ADC Facility in France
June 25, 2015
Contract Services
11
7
Novasep's new antibody drug conjugate facility at its site in Le Mans, France will be commissioned in 2016.
Pharmacy Associations Ask FDA to Delay Track-and-Trace Requirements
June 25, 2015
Supply Chain
11
7
Pharmacy associates say more education regarding the transactional requirements of DSCSA is needed.
apceth Expands GMP Manufacturing Capabilities with Addition of Two Cell and Gene Therapy Products
June 24, 2015
Contract Services
11
7
apceth has completed a major GMP inspection for two medicinal products. The two cell and gene therapy products are now included in the company’s GMP manufacturing license according to §13 of the German Medicines Act (AMG).
FDA Issues Guidance on Allowable Excess Volume for Injectables
June 24, 2015
Regulation and Compliance
11
7
The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.
Reach Separations Announces Major Expansion Initiative
June 24, 2015
Contract Services
11
7
Reach Separations has announced plans to double its laboratory space at its Nottingham facility as a result of increased demand for its specialist purification services.
Huntingdon and Harlan Laboratories to Become Envigo
June 24, 2015
Contract Services
11
7
The combined company has been created through the integration of Huntingdon Life Sciences and Harlan Laboratories announces a new company name.
FDA Fights Online Counterfeit Drugs
June 19, 2015
Supply Chain
11
7
The agency takes action against websites that illegally sell unapproved medications.
Lonza Invests in Viral Gene and Cell Therapies Facility
June 18, 2015
Contract Services
11
7
Lonza’s planned facility will be used to develop and manufacture viral gene therapies and virally modified cell therapies
Catalent expands packaging capabilities in Singapore
June 17, 2015
Contract Services
11
7
Catalent’s Singapore facility is awarded GMP certification.
Vetter Completes Expansion at Chicago Facility
June 17, 2015
Contract Services
11
7
Vetter completes on-site expansion activities of visual inspection and in-process control at Chicago facility.
West Breaks Ground on Facility in Ireland
June 16, 2015
Contract Services
11
7
West Pharmaceutical began construction on its component manufacturing facility located in Waterford, Ireland.
New England Biolabs to Build Manufacturing Plant
June 15, 2015
Contract Services
11
7
A new GMP facility in Massachusetts will produce enzymes and other reagents for in-vitro diagnostics.