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Top Stories
The trade and packaging fair, which was originally scheduled for May 7–13, 2020 in Düsseldorf, Germany, will be rescheduled for Feb. 25–March 3, 2021 in the same location.
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FDA postpones routine domestic facility inspections due to the COVID-19 pandemic.
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2019 PDA Quality Week | Dec. 9-13 | Washington, DC
The Week is comprised of three individual, but contiguous events designed to educate you on all aspects of QRM. Each offering provides a different perspective, starting with a focus on the emerging regulatory landscape, framing the requirements and objectives of the regulations that govern this important but elusive concept.
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Industry News
The test will use Applied Biosystems TaqPath Assay technology and will work to provide patient results within four hours of a sample being received by a lab.
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The National Institute for Health and Care Excellence (NICE) has issued a positive recommendation for Teva Pharmaceutical’s migraine therapy, Ajovy (fremanezumab).
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Exclusive Interview from AAPS:
Characterizing Deformation Properties of Directly Compressible Excipients using a Compaction Emulator
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Sponsored by: Natoli
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Supplier News
Through the agreement, Bora will obtain ownership of the entire Mississauga site, including all facilities, under the proper regulatory clearances.
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Launched in 2018, the Poseidon network works to bring together pharmaceutical providers to reform the pharmaceutical logistics process.
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Amid Global Supply Chain Uncertainty, Secure Yours with a US-Based Drug Substance Partner
Albemarle FCS is a trusted supplier of RSMs, intermediates and custom and generic APIs, with more than 40 years of experience and two closely-integrated US facilities. Learn how experience, quality and transparency translate to greater efficiency, security and reliability in your pharmaceutical supply chain.
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Bio/Pharma News
The decision comes after results were received from a Phase 1, open-label study that evaluated the safety, pharmacokinetics, and preliminary efficacy of the monotherapy
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Through the agreement, Emergent will manufacture the vaccine, which is formulated based on Novavax’s proprietary recombinant protein nanoparticle technology platform and its Matrix-M adjuvant to boost immune responses.
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Regulatory News
EMA, along with its partners across the European medicines regulatory network, are keeping a close watch on the pharmaceutical supply chains in the European Union as a result of the potential impact of COVID-19.
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The agency is postponing the inspection of most foreign facilities through April 2020.
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Featured Topics |
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MANUFACTURING
Understanding of scale-up parameters and use of process analytical technology are important to meet demand for larger batch sizes.
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OUTSOURCING
Can investing in early formulation studies drive a new therapy successfully across the commercialization finish line?
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DEVELOPMENT
Formulating fixed-dose combination drugs proves more complex than simply adding one ingredient to another.
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ANALYTICS
Metrology has the potential to not only prevent harm to patients but also to support innovative therapeutic options.
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PRODUCT/SERVICES PROFILES
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Catalent Biologics is a global leader in biopharmaceutical development services, bringing next-generation therapies to the market.
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CordenPharma is your full-service CDMO partner for APIs, Drug Products, and Packaging Services.
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At Lonza Pharma & Biotech, we provide contract development and manufacturing services that enable biotech and pharma companies to bring large and small-molecule medicines to patients in need.
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Over nearly two decades, TEDOR has helped customers meet their project timelines, achieve regulatory approvals, and solve formulation challenges.
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Thermo Fisher Scientific provides end- to-end development and manufacturing solutions to customers through Patheon and Fisher Clinical Services.
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ON DEMAND WEBCASTS
Lonza Capsugel® – The Right Partner for Your Next Drug Development Project
On Demand
Learn More
Introducing the New Portable XRF Analyzer for Identity Testing of Pharmaceutical Ionic Salts
On Demand
Learn More
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WEBCASTS
Sterile Filling Challenges for Early-Phase Product Development
Thursday, March 19, 2020 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET
Learn More
Striving for Zero Defects: Use of Quality-by-Design Principles for Manufacturing Parenteral Packaging Components to Mitigate Risks of Drug Product Contamination
Part I: Tuesday, April 7, 2020 at 10am EDT | 9am CDT | 3pm BST | 4pm CET
Learn More
Oral Peptide Delivery Utilizing Specialized Encapsulation Technologies
Wednesday, April 1, 2020 at 11am EDT | 8am PDT | 4pm GMT | 5pm CEST
Learn More
Optimizing Equipment Availability for Capsule Fillers
Tuesday, March 24, 2020 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET
Learn More
Integrated Pre-Formulation Studies for Fast Advancement of Drug Candidates to Human Clinical Studies
Wednesday, April 15, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Learn More
How to Perform Ignition and Drying Methods Such as USP <281> and USP <731> Safely Without Sacrificing Performance
Thursday, March 26, 2020 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET
Learn More
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Rescheduled Events
CPhI South East Asia has been rescheduled for July 2020.
Interphex 2020 has been rescheduled for July 2020.
PDA’s Annual Meeting has been rescheduled for July 2020.
Bioprocessing Summit Europe has been rescheduled for July 2020.
PDA’s Pharmaceutical Manufacturing Data Science Workshop has been rescheduled for July 2020.
Validation University has been rescheduled for August 2020.
CPhI North America has been rescheduled for September 2020.
CPhI Japan has been rescheduled for September 2020
Analytica 2020 has been rescheduled for October 2020.
Interpack 2020 has been rescheduled for February 2021.
more events
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eBOOKS
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In Pharmaceutical Technology's ongoing Pharmacopoeia Compliance Series, experts explain the revision process for global and national pharmacopoeias, best practices for monitoring changes, and how to participate in revisions. Other features include FDA warning letters, building a quality culture, and essentials for DOE and QRM.
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