November 23rd 2024
FDA's approval will allow Kedrion to manufacture Ryplazim (plasminogen, human-tvmh), the only FDA-approved therapy for treating PLGD-1, at facility in Bolognana, Italy.
The Thousand Oaks, Calif., cell therapy manufacturing facility now houses new production suites, updated development labs, and more after expansion.
November 22nd 2024
Sanofi will use this investment to increase its antibody bioproduction at its site in Lyon Gerland, France.
November 21st 2024
Located in German, Italy, and Lithuania, the new European facilities will specialize in drug discovery and R&D services.
November 20th 2024
SEKISUI has used a £15.7 million (US$20.7 million) investment to expand its clinical-grade drug substance manufacturing at its UK site.
Avara Buys Sterile Manufacturing Facility from Pfizer
The acquisition adds sterile manufacturing capability to the CDMO’s services, which include API formulation and manufacturing.
CordenPharma Adds Manufacturing Line for Vet Drug Products
CordenPharma is investing €10 Million in a new line at its Plankstadt, Germany site.
Lonza Launches New Biomanufacturing Complex
Lonza introduces new modular complex that offers flexibility and individually tailored solutions to biomanufacturing challenges.
JLL Reports Top 10 US Cities Preferred by Scientists
JLL ranks top 10 US life-sciences locations where scientists prefer to work and finds that location and workplace culture are key priorities.
New Guide Outlines Risks for Cross Contamination
Updated ISPE guidance offers risk assessment guidance to avoid cross contamination in multiproduct pharmaceutical manufacturing facilities.
Single-Use Technologies Transform Biopharmaceutical Facilities and Manufacturing Equipment
The advantages of single-use systems become clear as they become more broadly implemented.
Perspective: The Effect of Personalized Medicine
Biotech-based therapies and a move to single-use processes highlight recent industry changes.
Perspective: Consolidation Shapes Pharma
Pharma company consolidation and outsourcing led to a de-emphasis of manufacturing and reduced investment in new technologies and facilities.
Takeda Constructs High-Containment Facility in Ireland
Takeda will build a new production facility at its existing Grange Castle site in Ireland.
Facility Design Issues for Single-Use Processes
Single-use systems demonstrate advantages over stainless-steel systems for biopharmaceutical manufacturing facilities.
Compounding Pharmacy Cited for Unlicensed Biologics
FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.
Recipharm Opens New GMP Suite for Clinical Trial Materials
The new suite will be used to produce non-sterile dosage forms, such as metered dose inhalers and semisolid topical products, for clinical studies up to Phase II.
Flexible Conduits and Fittings Improve Power and Data Cable Installation
Flexicon’s flexible conduit ranges and hygienic fittings save space and time for power and data installations in pharmaceutical facilities.
Using Solar Energy for Process Heating
Renewable energy can improve energy efficiency and reduce carbon dioxide emissions in pharmaceutical manufacturing processes.
Allergopharma Begins Production at Reinbek Biopharmaceutical Facility
The company made a €42 million investment in a new building at its Reinbek site to support the production of biopharmaceuticals.
GMP Facility Modernization: Opportunities for Successful Implementation
The DME Facility Focus survey revealed best practices for coping with the challenges of aging facilities and implementing facility modernization.
ISPE Announces 2017 Facility of the Year Award Winners
The International Society for Pharmaceutical Engineering (ISPE) and its Facility of the Year Awards program announced its 2017 category award winners.
A Risk-Based Approach to Stainless Steel Equipment Maintenance
Laboratory tests can determine critical cleaning parameters for passivation treatments used to prevent rouge on GMP stainless-steel equipment.
Pumping Fluids in Biopharmaceutical Processing
Pump systems must be designed to meet the needs of specific processes, including preventing cross-contamination and damage due to shear forces.
FDA Gives UK Facility Warning Letter
The agency finds repeated CGMP violations at Porton Biopharma, Limited.
Vetter Starts Operations in Its Center for Visual Inspection and Logistics
Vetter expanded visual inspection facilities and controlled-temperature storage at its Ravensburg Vetter West facility in Germany.
Bedrocan's Netherlands Facility Becomes GMP Compliant
The medical cannabis producer has become compliant with EMA’s GMP standards.
MilliporeSigma Opens Production Facility in Mollet des Vallès
The company opened a facility in Spain dedicated to the production of meglumine.
bluebird bio and apceth Biopharma Enter Manufacturing Agreement
The companies entered a manufacturing agreement for the future commercial production of Lenti-D and LentiGlobin product candidates.
GSK Opens Global Vaccines R&D Center in Maryland
GlaxoSmithKline opened a new vaccines R&D center in Rockville, MD creating up to 200 new jobs.
Airlocks for cGMP Facilities
Airlocks, gowning rooms, and transition spaces have different uses and should be considered separately in cGMP pharmaceutical facility design.
Nitto Avecia Expands Oligonucleotide Manufacturing Capacity
Avecia is adding drug substance capacity at its Milford, MA manufacturing site.
Is Global Regulatory Gridlock Slowing Modernization?
PDA’s first aging facilities survey suggests that post-approval changes play a major part in slowing pharmaceutical industry investment in new technology.
Sartorius Stedim Biotech Opens Bioanalytical Testing Laboratory in Boston
The new Boston laboratory offers advanced analytical testing services.
Lonza Holds Grand Opening of New Drug Product Services Labs
The new facility will focus on formulation development, drug product analytical development, and quality control.