Liquid Dose Featured Articles
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FDA Releases Pre-Launch Activities Importation Requests (PLAIR) Guidance
5/24/2022
The FDA has finalized the draft guidance describing the policy regarding requests for the importation of unapproved finished dosage form drug products by applicants preparing products for U.S. market launch based on anticipated approval of a pending NDA, ANDA, BLA, or combination product assigned to CDER.
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6 Tips To Ensure Your NDA/BLA Is Ready For FDA Review
2/25/2022
When preparing a marketing authorization application for an NDA or a BLA, one aspect that is easily overlooked by small start-ups and mature multi-product drug sponsors alike is verification that all commitments made to the FDA have been completed and that evidence of this has been submitted to the agency.
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Factory/Site Acceptance Testing & Commissioning Responsibilities
2/22/2022
Execution of factory acceptance testing (FAT) and site acceptance testing (SAT) is a business-critical activity when it comes to commissioning of a new system or equipment. FAT is conducted at the equipment manufacturer’s site and SAT is conducted at the final site of installation. This article shares best practices.
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Pharmaceutical Liquid Filling Systems — A Succinct Comparison And Selection Guide
1/14/2022
View an attributes comparison of the primary strengths and weaknesses of the various filling systems based on the properties of the fill media, availability of additional functionality, filling tolerance, capital cost, and overall benefits and limitations.
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The 4 Ways AI Implementation Is Changing The Future Of Precision Medicine
12/10/2021
Part 1 of this two-part series examined how recent advances in for oncology diagnosis and treatment preview the full potential of precision medicine. This article, Part 2, shares insights on the 4 challenges the industry must overcome before individualized healthcare can be fully realized.
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Model-Based Control In Continuous Biomanufacturing
11/24/2021
In comparison to batch manufacturing, continuous manufacturing offers shorter development time, improved product quality, lower capital cost, and easy scale-up. The primary focus lies on establishing a flexible and standard platform with real-time monitoring, automated start-up/shut down, and a control strategy to address dynamic conditions.
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Two Emerging Fields Propelling AI In Precision Medicine
11/22/2021
Advances in AI-based analysis paradigms have created an unprecedented momentum in computational medical imaging applications, giving rise to new areas of precision medicine research. This article examines how recent medical imaging advances in oncology are bringing about new areas of precision medicine and previews its full potential.
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Juno v. Kite: Implications For Functionally Claimed Biologics
11/12/2021
The Federal Circuit recently reversed a jury verdict in the case Juno Therapeutics, Inc. v. Kite Pharma, Inc.., wiping out a $1.2 billion judgment for Juno in the lower court by invalidating claims directed to the functional properties of biological compounds that could be used as therapies. What does this mean for biologics developers going forward?
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Model-Based Control In Continuous Manufacturing of Biotherapeutics
11/10/2021
During continuous processing, automated control techniques coupled with process analytical tools are required to monitor critical quality attributes and implement real-time control decisions to handle deviations. This article is the first in a two-part series examining how model-based control can be effectively implemented in the various unit operations.
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Opportunities For Implantable Drug Delivery To Modernize Drug Therapy
11/8/2021
The implantable drug delivery system allows targeted and localized drug delivery for achieving an optimum therapeutic effect. This article examines the clinical significance of implantable drug delivery systems as well as opportunities that can be leveraged by drug therapy developers in meeting global health needs, particularly in the areas of women's health, cancer treatment, and ocular disease treatment.