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PTSM: Pharmaceutical Technology Sourcing and Management-10-07-2015
PTSM: Pharmaceutical Technology Sourcing and Management
Cost Inhibits CMO Adoption of Single-Use Equipment
October 07, 2015
Outsourcing
11
10
The high cost of disposables is a factor in restricting adoption of single-use devices.
Low Temperature Needed for Complex Drug Candidates
October 07, 2015
11
10
The use of low-temperature chemistry can often lead to more direct, cost-effective routes to sophisticated pharmaceutical compounds.
FDA Plans Pilot Projects for Drug Supply Chain Security Act
October 02, 2015
Supply Chain
11
10
FDA selected USDM Life Sciences, RC Partners, and The Clarion Group to develop and implement a DSCSA pilot project.
Vetter Embarks on 300-Million Euro Manufacturing Expansion
October 01, 2015
Contract Services
11
10
Vetter plans to invest approximately 300 million Euros during the course of five years to expand drug product manufacturing and logistic services in Germany; upgrades will include an improved RABS system for aseptic processing.
Sterigenics International Adds Capacity
October 01, 2015
Contract Services
11
10
Sterigenics International will triple West Memphis sterilization capacity with $15 million expansion.
Tecnandina’s Ecuador Facility Receives ANVISA Certification
October 01, 2015
Contract Services
11
10
The Grünenthal Group’s Tecnandina manufacturing plant in Ecuador has received the country’s first certification from the Regulatory Authority of Brazil.
Hovione Expands Drug Substance Manufacturing
September 29, 2015
11
10
Hovione will double its manufacturing capacity in New Jersey with an expanded facility and a commercial spray dryer designed to handle potent APIs.
Piramal Introduces Proof of Concept Service for Next Wave of ADC Growth
September 29, 2015
Contract Services
11
10
The CDMO is striving to become a market leader in the development and manufacturing of antibody-drug conjugates.
Patheon Unveils New Brand Identity
September 28, 2015
Contract Services
11
10
Pharma development and manufacturing firm Patheon announces new tagline and logo.
FDA Releases Guidance on Generic-Drug Development
September 28, 2015
11
10
The agency releases guidance on controlled correspondences related to generic-drug development.
Kopcha Selected to Head FDA’s Quality Office
September 28, 2015
11
10
Michael Kopcha has been named to lead CDER’s new Office of Pharmaceutical Quality.
Cobra Biologics Announces Scale-Up Collaboration
September 24, 2015
Contract Services
11
10
Cobra Biologics and the University of Manchester announce a collaboration to improve industrial scale-up of mammalian cell bioprocessing.
ReposiTrak Announces Track and Trace Agreement
September 22, 2015
Supply Chain
11
10
ReposiTrak signs agreement to pilot track and trace system in pharma.
Process Improves the Bioavailability of Active Ingredients
September 17, 2015
11
10
Supersonic spray-drying process yields stable and soluble amorphous nanoparticles.
EMD Millipore Provides Risk-Assessment Information for Raw Materials
September 16, 2015
11
10
EMD Millipore, the Life Science business of Merck KGaA, introduced expanded documentation and regulatory information for its Emprove portfolio of pharmaceutical raw materials, which include excipients, process chemicals, and APIs.
FDA Cites India API Facility For CGMP Violations
September 16, 2015
11
10
The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.
FDA Issues Import Ban for Indian Drug Manufacturer
September 16, 2015
11
10
Polydrug Laboratories is issued a US import alert, following similar bans in Canada and Europe.
ISO/IEC Approves GS1 EPCIS Standard
September 15, 2015
Supply Chain
11
10
GS1 standard tracks movement and status of goods, enabling better visibility, security and regulatory compliance.
CMO Industry Growth Unsustainable According to Report
September 14, 2015
Outsourcing
11
10
PharmSource forecasts slow growth in a new report on the outlook for the contract manufacturing industry.
SGS Attains Biosafety Level 2 Compliance at Fairfield, NJ Facility
September 10, 2015
Contract Services
11
10
SGS Life Science Services announced that its facility in Fairfield, NJ, has been upgraded to be Biosafety Level 2 (BSL-2) compliant, according to the Centers for Disease Control and Prevention (CDC) guidelines.
United Cargo Adds Temperature-Controlled Units
September 01, 2015
Supply Chain
11
10
United Cargo signs global rental agreement with va-Q-tec for controlled transport of pharmaceuticals.