Pharmaceutical Technology - PharmTech
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FDA Perspectives: Scientific Considerations of Forced Degradation ...
Published on: May 1, 2012. Pharmaceutical Technology, Pharmaceutical Technology-05-02-2012, Volume 36, Issue 5. The author outlines the scientific aspects of forced degradation studies that should be considered in relation to ANDA submissions. Forced degradation is synonymous with stress testing and purposeful degradation.
Novartis Acquires Calypso Biotech for up to $425 Million
On Jan. 8, 2024, Calypso Biotech, a European immunotherapy biotech company focused on the research and development of novel biologics, announced it had agreed to be acquired by Novartis. Calypso’s shareholders are set to receive an upfront payment of $250 million and are eligible to receive development milestones of up to $175 million, based ...
Trends in Digitalization of Pharma Manufacturing - PharmTech
May 17, 2021 · Trends in Digitalization of Pharma Manufacturing. Equipment and Processing Report, Equipment and Processing Report 05-19-21, Volume 14, Issue 5. Technology advances and pandemic environment drive increased use of automation and digital tools. The sudden, compulsory move to remote work during the COVID-19 …
Suitable Sterility Methods for Dimethyl Sulfoxide USP, PhEur
Sep 2, 2020 · Suitable Sterility Methods for Dimethyl Sulfoxide USP, PhEur. Pharmaceutical Technology, Pharmaceutical Technology-09-01-2020, Volume 2020 Supplement, Issue 4. Dimethyl sulfoxide is increasingly used in high-risk parenteral and medical device applications that must be manufactured as sterile products in their finished form.
Establishing Systems Suitability and Validity Criteria for Analytical ...
Feb 1, 2022 · Analytical methods and bioassays require a well-thought-out manner of evaluating method validity (truthfulness) and systems suitability (a known positive control) to ensure the method is correct, reliable, and can be used to determine the value of the unknown test article. This paper recommends and explains methods for evaluating system ...
Covalidation Strategies to Accelerate Analytical Method Transfer …
Apr 2, 2017 · Covalidation Strategies to Accelerate Analytical Method Transfer for Breakthrough Therapies. Published on: April 1, 2017. Yueer Shi, Nicola Hulme, Kieran O’Connor. Pharmaceutical Technology, Pharmaceutical Technology-04-02-2017, Volume 41, Issue 4. Pages: 38–41, 44–48.
Best Practices for Cleaning Validation Swab Recovery Studies
Sep 2, 2016 · Accepted: December 2, 2015. Parameters affecting cleaning validation swab recovery studies include: the material of construction coupon, residue spike level (s), swab recovering the residue, swab personnel, swab extraction, and test method. Each of these swab recovery parameters are reviewed in detail to define best practices and highlight ...
Understanding the Value of Excipient Grade - pharmtech.com
Sep 10, 2024 · Understanding the Value of Excipient Grade. Pharmaceutical Technology, Pharmaceutical Technology, September 2024, Volume 48, Issue 9. Greater collaboration and understanding are needed to ensure the correct grade of excipient is used in drug products. Excipients commonly make up the largest proportion of many drug dosage forms, performing ...