Tag: <span>critical quality attributes</span>

A Qualitative Risk-Benefit Structure for Developing and Manufacturing Biopharmaceuticals

Biopharmaceutical manufacturing will continue to be increasingly challenging as medical knowledge and understanding rapidly advance. Many new therapies and products will utilize cellular, viral, genetic, and epigenetic approaches along with a repertoire of increasingly complex proteins targeting a rapidly increasing inventory of newly discovered biomarkers. Manufacturing these products efficiently, consistently, and reliably will require sophisticated manufacturing approaches, methods, and controls. In addition, growing patient, societal, and even regulatory pressures demand that new therapeutics be developed and manufactured quickly, reliably, and efficiently.

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Bioinformatics Biologics Biologics Production Quality Risk Management (QRM) Regulatory Research

12cfr211 achieving manufacturing excellence amps appropriate manufacturing practices bioburden control cgmp critical quality attributes generalized risk structure GMP ichq7a ichq8 ichq9 manufacturing enterprise

Using a Patient-Centered Risk-Benefit Structure and Appropriate Manufacturing Practices (AMPs) for Successfully Developing and Manufacturing Effective Cell Therapy Products

The development and manufacturing of advanced breakthrough cell therapies presents a wide variety of complex challenges that include:
• delivering the medical science, from research all the way through product development and clinical testing, to the patient population;
• understanding and defining the product’s modes of activity and the cell’s attributes necessary to attain therapeutic benefit and safety;
• overcoming significant manufacturing, logistical, and cost of goods issues associated with using attachment-dependent bioreactor systems; and
• defining product release challenges associated with rapidly delivering an effective product to the patients.

Read MoreUsing a Patient-Centered Risk-Benefit Structure and Appropriate Manufacturing Practices (AMPs) for Successfully Developing and Manufacturing Effective Cell Therapy Products

Biologics Biologics Production Bioreactor Scale-Up Cell & Gene Therapy Cell Lines Fed-Batch Bioreactor Process HEK293 Mammalian Cell Culture Manufacturing Regulatory Viral Reference Materials Viral Vectors

amps appropriate manufacturing practices cell therapy cellular therapy cost of goods cqas critical quality attributes preclinical manufacturing process lifecycle paradigms risk-benefit structure

Quality Risk Management (QRM): Part II – Evaluating the Impact of Process Parameters on Critical Quality Attributes for Biopharmaceutical Products

This paper, the second in a three-part series on ICH Q9 quality risk management (QRM), uses a process-based risk structure to identify product quality risks from variability in input parameters and process behavior. This paper outlines a method to identify the three types of input parameters and how they can be placed into an ICH Q8 defined design space structured to clearly categorize and control the input parameters such that they can be evaluated for their impact on product critical quality attributes (CQAs). Based on their placement in the well-structured design space, the parameters are rated using a risk severity and uncertainty index to calculate a risk rating for review and acceptance. The process-based risk structure can also be used to mitigate the likelihood of the risk consequence by modifying the processes to manage the uncertainty of the input parameters and control the process’s behavior…

Read MoreQuality Risk Management (QRM): Part II – Evaluating the Impact of Process Parameters on Critical Quality Attributes for Biopharmaceutical Products

Risk Analysis and Management

critical process parameters critical quality attributes risk rating risk severity and uncertainty index