Effects of Tank-Agitated Fermentation on Therapeutic mAb Quality

About the Author

Anelis Quintana Cantillo, MSc, holds a bachelor’s degree in biology and a master’s degree in drug technology and control, both from Havana University. Anelis currently...

Wendy Montero Pérez

Wendy Montero Pérez has a bachelor’s degree in pharmaceutical sciences from Havana University. She works in the Department of Quality Assurance at the Center of...

Azalia De La Caridad Rodríguez Taño, MSc

Azalia de la Caridad Rodríguez Taño, MSc, has a bachelor’s degree in biochemistry and molecular biology and a master’s degree in biochemistry, both from Havana...

Olga Lidia Fernandez Saez

Olga Lidea Fernandez Saez graduated as a technician in industrial chemistry. Since then, she has worked as a control process analyst in the R&D BioProcess...

Leina Moro Pérez

Leina Moro Pérez holds a bachelor of science in biochemistry and molecular biology from Havana University. Leina works as Purification Specialist in the R&D BioProcess...

Alexi Bueno Soler

Alexi Bueno Soler is a Chemical Engineer who has worked in the R&D BioProcess Development Department at the Center of Molecular Immunology in Havana since...

José Luis Durán

José Luis Durán graduated as a technician in industrial chemistry. He works on the purification of mAbs and therapeutic vaccines in the R&D BioProcess Development...

José Arquímides Castro Del Pino

Tammy Boggiano Ayo

Tammy Boggiano Ayo, MSc, has a bachelor of science in radiochemistry and a master of science in biotechnology from Havana University. From 2010 to 2016...

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

Entering a New Era of Innovation and Collaboration With the Focus on the Workforce of the Future

Q&A with ISPE Foundation Professional Development Grant Recipient Silas Tamufor

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