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Top Stories
Updates on COVID-19 vaccine candidates, FDA policies, company partnerships, and more.
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Through the agreement, BARDA will support the advancement of the vaccine candidate to FDA licensure and will handle all late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacture in 2020.
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Industry News
Experts to discuss strategies for ensuring supply of quality drug products during a pandemic in April 28 online event.
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The company is recalling Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles because of failed dissolution specifications.
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Exclusive Interview from AAPS:
Advancements in lipid-based delivery systems
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Supplier News
Suppliers to the bio/pharma industry are sharing news about the business operations during the global COVID-19 pandemic. To view current information about the company’s business operations, click the company name.
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The report outlines the company’s approaches to product quality, safety, environmental sustainability, and diversity and inclusion.
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Bio/Pharma News
This milestone achievement will allow the companies to move forward with developing a GMP-compliant manufacturing process for clinical testing.
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Biopharmaceutical company, TScan Therapeutics, has entered into a collaboration agreement with Novartis that is aimed at the discovery and development of novel T-cell receptor (TCR) therapies for solid tumors.
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Regulatory News
The guidance document describes the agency’s temporary policy for the compounding of drugs during the COVID-19 pandemic.
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The agency sent warning letters to three more companies for selling unapproved products claiming to treat COVID-19.
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Featured Topics |
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SUPPLY CHAIN
Risk assessments, audits, and good communication between sponsor and supplier are key elements of supplier oversight.
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QUALITY/REGULATIONS
With ingredients sold to multiple markets, excipient manufacturers must understand the different regulatory requirements for pharma vs. food.
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MANUFACTURING
Risk levels should be considered when designing containment for pharmaceutical tableting equipment to enhance operator safety.
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PEER-REVIEWED RESEARCH
This case study highlights analytical instrumentation and techniques that were used to identify an unknown impurity detected during routine release testing of a topical gel drug product.
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WEBCASTS
Through Container Verification of Pharmaceutical Raw Materials with the New Agilent Vaya Handheld Raman System
Europe Broadcast: Thursday, May 14, 2020 at 9am EDT | 2pm BST | 3pm CEST
US Broadcast: Thursday, May 14, 2020 at 2pm EDT | 1pm CDT | 11am PDT
Asia Pacific Broadcast: Friday, May 15, 2020 at 8:30am IST | 11am CST | 12pm JST | 1pm AEST
Learn More
When Drug Meets Device: How to Assess Compatibility
Tuesday, May 19, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Learn More
Ensuring the Continuous Supply of Quality Drug Products During Uncertain Times
Tuesday, April 28, 2020, 11 am EDT | 10 am CDT | 8 am PDT
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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The Pharmacopoeia Compliance Series features a description of ways bio/pharma companies can participate in monograph development, a practical approach to pharmacopoeial compliance, and a summary of this 12-part series.
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