Process Analytical Technology (PAT) for Bioprocessing LCDR Cyrus Agarabi, PharmD, PhD, MBA Division of Biotechnology Review and Research-II OBP/OPQ/CDER June 8, 2016 *Disclaimer: The views expressed are presented by the authors for consideration. They do not necessarily reflect current or future FDA policy or official views of the US Government.
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Process Analytical Technology
(PAT) for Bioprocessing
LCDR Cyrus Agarabi, PharmD, PhD, MBA
Division of Biotechnology Review and Research-II
OBP/OPQ/CDER
June 8, 2016
*Disclaimer: The views expressed are presented by the authors for consideration. They do not
necessarily reflect current or future FDA policy or official views of the US Government.
Outline
Background
Bioprocessing & mAb Overview
PAT Research Examples and Opportunities
2
Office of
Program and
Regulatory
Operations
Office of Policy
for
Pharmaceutical
Quality
Office of
Biotechnology
Products
Office of New
Drug Products
Office of
Lifecycle Drug
Products
Office of
Testing and
Research
Office of
Surveillance
Office of
Process and
Facilities
Office of Pharmaceutical
Quality (OPQ)
Center for Drug Evaluation and
Research (CDER)
Food and Drug Administration
(FDA)
Why Regulatory Research?
• Outreach- Internal/External Stakeholders
• Discuss regulatory research to support FDA
guidance documents (PAT, QbD, etc)
• Reviewer Training
• Internal/external training on bioprocessing
equipment and analytics
• Support Biotech Regulatory Decisions
• Support policy development
• Support biotech review decisions 4
PAT Guidance Released September 29, 2004
Scientific principles and tools – Process Understanding
The Essence of PAT Product quality is monitored and controlled during the
manufacturing process.
Process decisions are based on assessments of material
attributes.
Forward-feed of incoming material
In-process monitoring & control
Critical product attributes measured/assessed
Instantaneously (on-line, in-line, at-line) or
Before decision point (near at-line)
• With as large a window as feasible 6
7 *For illustrative purposes only- Data generated by Google Trends Based on searches for “Process Analytical Technology”
Google search interest for “Process Analytical
Technology” (2004-Current)
• Where do we go from here?
• How can PAT play an important role in new initiatives?
PAT Guidance Released
0
50
100
What is an Emerging Technology? Technology with which the FDA has limited review or inspection experience New (or not previously applied to pharmaceutical applications) to support more robust, predictable, and/or cost-effective processes or novel products Innovative or novel products, manufacturing processes, or analytical technology subject to CMC review Examples: •Continuous manufacturing of drug substances and drug products
•“On-demand” manufacturing of drug products
•Aseptic filling closed system
•3-D printed tablets
•New container and closure systems for injectable products
Emerging Technology Team (ETT)
A small cross functional team with representation from all relevant CDER review and inspection programs Encourage and support the adoption of innovative technology to modernize pharmaceutical development and manufacturing Two tracks:
• Stand alone innovative or novel product, manufacturing process, or analytical technology
• Existing or planned submission(s) with the above