Quality Control/Quality Assurance

New biologic modalities, such as cell and gene therapies, pose increasing difficulties in viral clearance testing methods.

Help prevent contamination in a facility by zone.

Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.

Digitalization of bioprocessing operations, equipment, and facilities can improve workflow and output, but maintaining data integrity is a concern.

The increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.

ISPE’s latest guide ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry focuses on how knowledge management allows for a more effective pharmaceutical quality system.

Assessing biosafety using NGS-based tests requires a continuum of skills in molecular biology, biocomputing, virology, and quality systems.

The COVID-19 pandemic has triggered additional considerations to supplier oversight of contract manufacturing facilities.

A best practices approach to pharma’s most challenging-to-inspect container.

System documentation should include a system description, history, validation information, and references, according to Siegfried Schmitt, Vice President, Technical at Parexel.

Waters and Genovis will work to develop automated workflows for the fast and constant characterization of critical quality attributes of monoclonal antibodies and other protein-based drugs in bioprocess development, formulation, stability testing, and quality control.

FDA has called a halt in production of vaccine drug substance and to quarantine all remaining product at the Bayview plant.

This new technology could eliminate the need for cold chain storage, transport, and distribution of temperature-sensitive molecules.

Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.

Dynamic light scattering presents a good analytical technique for testing protein stability.

Many biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.

Maintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.

A growing pipeline of gene therapy candidates aimed at treating neurodegenerative diseases has prompted new guidance.

Auditing distribution suppliers provides understanding and documentation of the services performed.

The company recently installed a fully validated visual inspection system that uses artificial intelligence in an automated inspection machine.

PathoQuest will apply its experience in viral safety testing and quality control of biologics for mitigating the risk of adventitious agent contamination in biopharmaceutical manufacturing.

Amid the rush for a SARS-CoV-2 vaccine to deal with the COVID-19 pandemic, a robust risk assessment must be conducted, and mitigation strategies applied.

With appropriate planning and the proper use of technology, remote auditing can be as effective and informative as in-person auditing.

Clear understanding of what exactly the biomolecule entails is essential.

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.

The Vaccines Manufacturing and Innovation Centre (VMIC) has chosen Lonza’s MODA-EM solution for the digitalization of its microbiology quality control operations.

The collaboration addresses the need for risk mitigation plans in cell therapies.

A holistic approach to validation and quality assurance is essential.

Experts examine the role technology can play in quality programs at the 2020 Bio/Pharma Virtual Congress.

Successful migrations require careful planning to meet business needs and maintain data integrity.