Pharmaceutical Technology

OCTOBER 28, 2022

Quality by design (QbD) is a concept introduced into the pharmaceutical regulatory lexicon in 2005. It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Practising QbD in biosimilar product development.

Bioequivalency 130

Bioequivalency Production Branding Contamination 130

Drug Discovery World

OCTOBER 12, 2022

In the Quality by Design (QbD) approach to antibody-based therapeutics development, stability characterisation —the probability of a protein unfolding or denaturing— is performed to ensure that structure and function are preserved throughout development and manufacturing. . How storage conditions affect mAb stability .

Antibody 52

Antibody Development Licensing Licensing 52

Drug Discovery World

OCTOBER 12, 2022

In the Quality by Design (QbD) approach to antibody-based therapeutics development, stability characterisation —the probability of a protein unfolding or denaturing— is performed to ensure that structure and function are preserved throughout development and manufacturing. . How storage conditions affect mAb stability .

Antibody 52

Antibody Development Licensing Licensing 52

Drug Discovery World

FEBRUARY 28, 2023

Dr Asma Patel , Vice President of Integrated Services for Early Development at Quotient Sciences, reflects on the biggest barriers to rare disease drug development and how companies can overcome these. Utilising an integrated approach for development can improve the likelihood of downstream clinical and commercial success.

Development 52

Development Drugs Manufacturing Production 52

Drug Discovery World

MARCH 16, 2023

Challenges of cell and gene therapy manufacturing Compared to traditional biologics, CGTs are living drugs, making their development and manufacturing substantially more complex. Importantly, we need to eliminate information silos and integrate across teams and institutions to develop rigorous developmental protocols.

Gene Therapy 52

Gene Therapy Gene Manufacturing Life Science 52

CTTI (Clinical Trials Transformation Initiative)

APRIL 25, 2023

Engaging all stakeholders during the earliest stages of study development is an important feature of quality by design (QbD).

Trials 45

Trials Clinical Trials Clinical Trials Clinical Research 45

ACRP blog

NOVEMBER 22, 2022

Rewarding critical thinking and open dialogue is critical to the success of high-quality studies and development programs.”. Quality by design (QbD) continues to be vital to compliance with the ICH E8(R1) guideline from the International Council for Harmonization, General Considerations for Clinical Studies.

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Compliance Clinical Research Development Drugs 52