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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
January 01, 2021
Clear understanding of what exactly the biomolecule entails is essential.
December 15, 2020
The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System is the first in a four-part series that will address refining pharmaceutical quality and guaranteeing sustainable compliance within organizations.
December 11, 2020
The Vaccines Manufacturing and Innovation Centre (VMIC) has chosen Lonza’s MODA-EM solution for the digitalization of its microbiology quality control operations.
December 03, 2020
The collaboration addresses the need for risk mitigation plans in cell therapies.
December 02, 2020
A holistic approach to validation and quality assurance is essential.
November 04, 2020
Experts examine the role technology can play in quality programs at the 2020 Bio/Pharma Virtual Congress.
November 02, 2020
Successful migrations require careful planning to meet business needs and maintain data integrity.
November 01, 2020
The shift to single-use technologies is driving the need for innovation in PAT-friendly sensor technologies.
Complex manufacturing processes pose challenges for final product inspection needed to ensure product integrity at commercial launch.
Early detection and more sensitive methods of detecting adventitious agents are becoming increasingly critical in bioprocessing.
Siegfried Schmitt, vice president, Technical at Parexel, offers insight into FDA’s guidance on performing operations during COVID-19.
October 16, 2020
AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
October 15, 2020
The IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.
Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.
October 02, 2020
Automation, digitalization, and supply-chain strategies help mitigate vulnerabilities in both autologous and allogeneic cell therapy manufacturing.
October 01, 2020
Fill/finish inspection for vaccine vials and syringes must remain GMP-compliant while aiming for fast, efficient methods.
A data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software.
September 18, 2020
The agency sent a warning letter to Kalchem International for CGMP violations found at the company’s Lindsay, OK, facility.
September 08, 2020
Industry leaders insist they will maintain high standards for clinical trials and regulatory submissions for new vaccines and therapeutics to combat COVID-19.
September 02, 2020
The companies have entered into a strategic partnership for the CMC development and manufacturing of Ansun’s biologics pipeline.