Pharmaceutical Technology-03-15-2021

Pharmaceutical Technology

It Takes a Bio/Pharma Village

March 16, 2021

Quality Collaboration

2021 eBook

1

Precompetitive efforts of the members of the IQ Consortium have demonstrated that collaboration from a global bio/pharma village is essential to serve patients.

Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based Strategies

March 16, 2021

Quality Collaboration

2021 eBook

1

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.

Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug Development

March 16, 2021

Quality Collaboration

2021 eBook

1

Extrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.

Collaborative Efforts Address Key Data Integrity Challenges

March 16, 2021

Quality Collaboration

2021 eBook

1

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.

Can FDA Reinvent Inspections

March 16, 2021

Quality

2021 eBook

1

A plant inspection backlog caused by COVID-19 restrictions threatens innovation and public health. Now pressured to step up on-site inspections, will FDA embrace new methods?

A Real-World Approach to Evaluating Cleanroom Garments

March 15, 2021

Operations

2021 eBook

1

Traditional methods of testing cleanroom garments fail to test for dynamic conditions in the cleanroom. A holistic approach considers particulate shedding and heat load during processing, as well as the impact of laundering on garment life cycle.