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Right product, right place, right away In the world of healthcare and medicine, the unavailability of a drug, treatment option or piece of medical equipment when and where it’s needed due to a supply chain issue may not only be frustrating, it could threaten a person’s health. What are some positive steps various parts of the drug supply chain can take today, individually and collectively, to maximize supply chain resilience?
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CSA a game changer for the life sciences? A look at FDA's new approach to computer system validation and the testing / documentation of non-product software used in drug manufacturing—one that emphasizes critical thinking early in the process.
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Catalent boosts cold chain packaging services
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Bosch Service Solutions will acquire Elpro for pharma logistics temperature monitoring
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CSafe Global purchases Softbox Systems, increasing presence in cold chain shipping space
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CSafe Global purchases Softbox Systems, increasing presence in cold chain shipping space
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The Pandemic Didn’t Hinder Drug Launches, but it Has Altered Sales Tactics
Check out this article where Brian Corvino, Managing Director Candy Lurken, Principal from Deloitte Consulting, LLP discuss the different ways that the pandemic has changed the sale tactics used.
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Application for COVID-19 Treatment Submitted to EMA
The agency received a marketing authorization appli‐cation a monoclonal antibody treatment for COVID-19 patients.
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EMA Approves Manufacturing Site for Janssen COVID-19 Vaccine
The agency's human medicines committee approved an additional site in West Point, Pa. in the United States for the manufacture of Janssen’s COVID-19 vaccine.
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Selecta Biosciences and Takeda Announce
Gene Therapy Platform Licensing Agreement
Takeda will use Selecta Bioscience's ImmTOR platform to develop gene therapies for lysosomal storage disor‐ders.
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Merck and Ridgeback Biotherapeutics’ Oral
Antiviral COVID-19 Treatment Reduces Risk
of Hospitalization or Death by 50%
Merck and Ridgeback Biotherapeutics' oral antivira medication reduced the risk of hospitalization or death from COVID-19 by 50% relative to placebo a Phase III clinical study.
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Thermo Fisher Scientific Opens Biologics Manufacturing Site in Lengnau, Switzerland
Thermo Fisher's new Swiss facility will initially produce CSL Limited’s recombinant factor IX product Idelvion.
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SGS Completes Expansion of Bioanalytical Testing Laboratory in France
The expansion to SGS’s Poitiers facility in France expected to improve the company’s drug develop ‐ment capabilities.
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Embedded Intelligence at the Right Time – How Next Best Can Change Behaviors
Wednesday, June 9, 2021 at 11am EDT
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DEVELOPMENT
Considering Bio/Pharma Reformulation
Strategies
Reformulation strategies are useful tools for more than just stretching out the potential return on investment for a product.
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MANUFACTURING
Automating Aseptic Manufacturing
Conventional and robotic automation inside closed sys‐tems reduces risk.
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QUALITY SYSTEMS
European Pharmacopoeia Updates: EDQM
Tackles Nitrosamine Impurities
Updates to Ph. Eur. include validated tests for N-nitrosamine impurities in sartan APIs.
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ANALYTICS
Determining Shelf Life: Reading the Stability
Testing Data
Although stability testing programs for small-mol‐ecule drugs and biologics are often perceived as similar, stability programs for biologics are far more complex.
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Interphex 2021
Javits Center, New York, USA
19–21 October 2021
CPhI Worldwide
Milan, Italy
9–11 November 2021
2021 ISPE Pharma 4.0 and Annex 1 Conference
Vienna, Austria
8–9 December 2021
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Subscribers can enjoy each full issue of Pharm Tech Europe in print, or via Pharm Tech Europe apps.
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Regulatory Sourcebook, September 2021
For bio/pharmaceutical companies, quality must be more than a vague concept. Quality practices impact all aspects of drug development and manufacturing. In the Pharma‐ceutical Technology Regulatory Sourcebook, experts share insights and best practices on a range of quality issues.
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Decision Intelligence – How AI/ML Discovery and Adoption Informs Smarter Processes
Wednesday, June 30, 2021 at 11am EDT
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