Accelerating Biopharmaceutical Virtual FATs in a Pandemic

About the Author

Vice President

Itaan Pharma

Dr. Ajay Babu Pazhayattil is a seasoned professional who has led technical operations, quality assurance, regulatory compliance risk mitigation, and remediation projects. He has conceived...

Kishorkumar Kotini

Validation Engineer

August Bioservices

Kishorkumar Kotini is Senior Validation Engineer, MSAT, at August Bioservices, a US-based CRO/CDMO, offering a full range of drug discovery, drug development, and drug manufacturing...

Mythri Kodidela

Sr. Validation Engineer

August Bioservices

Mythri Kodidela is Senior Validation Engineer, MSAT, at August Bioservices, a US-based CRO/CDMO, offering a full range of drug discovery, drug development, and drug manufacturing...

Mike Scribner

Vice President, Quality

August Bioservices

Mike Scribner is Vice President, Quality, at August Bioservices, a US-based CRO/CDMO, offering a full range of drug discovery, drug development, and drug manufacturing capabilities...

Technical

Selection Criteria for Pharmaceutical Containment Equipment

1 March 2024

Pharmaceutical manufacturing facilities produce a variety of products, including highly potent products that require safety measures to prevent adverse health effects on patients and operators. To ensure safety, these facilities use containment equipment to minimize the risk of contamination. This article presents criteria for selecting containment equipment, considering both...

Technical

A Sustainable Approach to Steam Quality Management

1 March 2024

The world is beginning to grasp the huge challenge of achieving net-zero carbon emissions, or carbon neutrality, by 2050. Many countries have committed to achieving this ambitious goal. As a major global industry, the pharmaceutical sector has a significant role to play. For thermal energy–intensive industries, such as pharmaceutical manufacturing, the long-term future options to maintain...

Technical

Concluding Compliance Challenges with Validation 4.0

13 March 2024

As the pharma industry moves to an ambitious Validation 4.0 paradigm, computerized systems play a pivotal role in enabling the rapid transition. Innovation and agility in computerized system validation (CSV) received a strong push in the second half of 2022 with the publication of the FDA draft guidance on “Computer Software Assurance for Production and Quality System Software”

About the Author

Facilities of the Future: Meeting the Demands of Breakthrough Therapeutics

Emerging Leader Hacker to GAMPer in 10 Weeks

New Initiative Seeks to Back up ICHs Harmonization Mission

Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization

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