Search results for " quality"
Article
A Look Ahead at BioPharma Manufacturing and Regulation
The most common definition of regulatory science is a discipline that creates new tools, standards, and approaches for use in assessing the safety, effectiveness, quality, and performance of products.…
Article
Assessing Manufacturing Process Robustness
ICH guidelines Q8–Q12 (1–5) and those in development such as ICH Q14 (6) have applied science, risk management, and quality systems to enhance process and product quality.
In 2011, …
Article
Supply Chain Challenges for Single-Use Systems
The large number of raw materials makes forecasting demand more difficult and requires robust materials management, supplier quality management, quality control, and business continuity planning to en…
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
During development and quality control, a range of analytical technologies are used to characterize biotherapeutic drugs, including methods to analyze their structural integrity and activity. Target/l…
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Addressing the Complex Nature of Downstream Processing with QbD
The International Council for Harmonization (ICH) defines QbD as a systematic approach that incorporates prior knowledge, results of studies using design of experiments (DoE), use of quality risk mana…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Such advances, though, require further clarification of regulatory policies governing gene therapy production and quality assurance.
FDA is considering at least three CAR-T applications, and mo…
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Best Practices in Qualification of Single-Use Systems
There are many factors to be evaluated, including technical assessment, supply chain, business aspects, and supplier quality. PDA
Technical Report No. 66, Application of Single-Use Systems in Pharma…
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Advancing QbD in the EU
The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD) concepts over the past 10 years. In 2003, EMA set up a team to back activities in pro…
Article
Moving PAT from Concept to Reality
In many cases, Makowiecki adds, reliable, low cost, on-line/at-line analytical sensors needed for the measurement of critical product quality attributes and product-related species are not commercial…
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Optimizing Late-Stage and Commercial Cell-Culture Processes
Over the years, cell-culture processes have evolved to achieve optimum production yield and quality for both clinical development and commercial manufacturing.
Cell-culture evolution
Current c…