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© 2020 MJH Life Sciences and BioPharm International. All rights reserved.
© 2020 MJH Life Sciences™ and BioPharm International. All rights reserved.
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.
The agency sent a warning letter after an inspection of the company’s Sangareddy District, India found inadequate cleaning procedures.
The increased use of single-use bags in biologic manufacturing poses the risk of pinholes and other defects that cannot currently be tested for.
September 01, 2020
As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.
Current and newer biologic modalities pose increasingly complex challenges to the detection and characterization of protein aggregates.
August 11, 2020
The guidance is intended to assist IND sponsors in determining the need for drug-drug interaction studies.
August 05, 2020
Healthcare groups met in late July 2020 to discuss the state of the US pharmaceutical supply chain and the impact of COVID-19.
August 02, 2020
Process modeling offers an opportunity to troubleshoot for and anticipate difficult aspects of a bioprocess.
August 01, 2020
Data from migration kinetics studies can be used to develop models that predict levels of leachables and extractables at different temperatures and time points.
Efforts are already underway to harmonize standards and regulatory approaches for testing of raw and ancillary materials, but continuous improvement is required.
Glycoengineering is growing in importance as a technique to improve antibody therapeutic efficacy, safety, and product quality.
July 23, 2020
The European Medicines Agency has set up an infrastructure to support real-world monitoring of the efficacy and safety of COVID-19 vaccines and treatments.