Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Improving drug manufacturing with process analytical technology.

Licinia O Rodrigues1, Teresa P Alves, Joaquim P Cardoso

  • 1CIPAN SA, Castanheira do Ribatejo, Portugal.

Idrugs : the Investigational Drugs Journal
|December 24, 2005
PubMed
Summary

Process Analytical Technology (PAT) implementation, beyond basic quality control, enhances understanding and control in pharmaceutical manufacturing. Advanced PAT applications improve process insights and operational efficiency for bulk active pharmaceutical ingredients.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Analytical Method Lifecycle Management in Pharmaceutical Industry: a Review.

AAPS PharmSciTech·2021
Same author

Improving reliability of Raman spectroscopy for mAb production by upstream processes during bioprocess development stages.

Talanta·2019
Same author

Monitoring mAb cultivations with in-situ raman spectroscopy: The influence of spectral selectivity on calibration models and industrial use as reliable PAT tool.

Biotechnology progress·2018
Same author

A QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016.

PDA journal of pharmaceutical science and technology·2017
Same author

Supervisory control system for monitoring a pharmaceutical hot melt extrusion process.

AAPS PharmSciTech·2013
Same author

Near-infrared and two-dimensional fluorescence spectroscopy monitoring of monoclonal antibody fermentation media quality: aged media decreases cell growth.

Biotechnology journal·2013

Area of Science:

  • Pharmaceutical Manufacturing
  • Chemical Engineering
  • Process Control

Background:

  • The US Food and Drug Administration (FDA) guidelines promote Process Analytical Technology (PAT) for consistent quality in manufacturing.
  • PAT implementation can range from simple quality control replacement to extensive process integration.
  • Limited reports exist on advanced PAT applications (Types 2 and 3) in industrial settings.

Purpose of the Study:

  • To describe and demonstrate the benefits of advanced PAT implementation (Types 2 and 3).
  • To showcase PAT's role in enhancing process understanding and control for bulk active pharmaceutical ingredients (APIs).

Main Methods:

  • Implementation of PAT Type 2: integrating in-process monitoring for enhanced process understanding in an existing industrial process.

Related Experiment Videos

  • Implementation of PAT Type 3: exclusive use of PAT throughout development, scale-up, and production of a new product.
  • Application in two distinct industrial processes for bulk API preparation.

    • Main Results:

    • Achieved increased process understanding through advanced PAT integration.
    • Demonstrated enhanced process control capabilities with PAT implementation.
    • Provided empirical evidence for the benefits of advanced PAT in API manufacturing.

    Conclusions:

    • Advanced PAT implementation (Types 2 and 3) offers significant advantages over basic quality control replacement.
    • These advanced PAT strategies lead to improved process comprehension and operational control in bulk API production.
    • Further adoption of comprehensive PAT approaches is encouraged for pharmaceutical process optimization.