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 Concept Videos

Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

Biopharmaceutical Factors Influencing Drug Product Design: Overview

46
Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though...
46
Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

24
Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
24
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

28
Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
28
Bioavailability Enhancement: Drug Stability Enhancement and GI Retention01:05

Bioavailability Enhancement: Drug Stability Enhancement and GI Retention

23
Body:Improving a drug's stability in the gastrointestinal (GI) tract is paramount for enhancing its bioavailability and therapeutic effectiveness. Various strategies are employed to protect the drug from the harsh gastric milieu and to ensure its release and absorption at the desired site within the GI tract.Polymer coatings are one such method used to shield drugs from the stomach's acidic environment. By preventing premature drug release, these coatings improve the bioavailability of unstable...
23
Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

219
Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
219
Bioavailability Enhancement: Determination and Conceptual Approaches in Overcoming Bioavailability Problems01:22

Bioavailability Enhancement: Determination and Conceptual Approaches in Overcoming Bioavailability Problems

20
Body:Bioavailability is a critical pharmacological concept that measures the extent and rate at which an active drug ingredient or therapeutic moiety enters the systemic circulation, remaining unchanged. It's a pivotal factor in determining a drug's efficacy and safety.The Biopharmaceutics Classification System (BCS) plays an essential role in drug development by categorizing drugs into four classes based on their solubility and permeability. This classification aids in understanding drug...
20

You might also read

Related Articles

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

Sort by
Same author

High-Dose Subcutaneous Administration of Biologics: Overcoming Barriers Through Formulation and Device Innovation.

Advanced drug delivery reviews·2026
Same author

Pioneering the future: Delivering the first digitally generated CMC post-approval change dossier to global regulators simultaneously.

Journal of pharmaceutical sciences·2026
Same author

Advancing the implementation of innovative analytical technologies in pharmaceutical manufacturing-Some regulatory considerations.

Journal of pharmaceutical sciences·2024
Same author

Patient-Centric Quality Standards.

Journal of pharmaceutical sciences·2024
Same author

Real-time algorithmic exchange and processing of pharmaceutical quality data and information.

International journal of pharmaceutics·2023
Same author

Structured content and data management-enhancing acceleration in drug development through efficiency in data exchange.

AAPS open·2023

Related Experiment Video

Updated: Oct 21, 2025

Process Optimization using High Throughput Automated Micro-Bioreactors in Chinese Hamster Ovary Cell Cultivation
09:28

Process Optimization using High Throughput Automated Micro-Bioreactors in Chinese Hamster Ovary Cell Cultivation

Published on: May 18, 2020

8.9K

Re-Envisioning Pharmaceutical Manufacturing: Increasing Agility for Global Patient Access.

Marquerita Algorri1, Michael J Abernathy1, Nina S Cauchon1

  • 1Department of Global Regulatory Affairs and Strategy-CMC, Amgen Inc, Thousand Oaks, California 91320, USA.

Journal of Pharmaceutical Sciences
|September 3, 2021
PubMed
Summary
This summary is machine-generated.

Agile manufacturing offers flexible, decentralized pharmaceutical production for personalized medicines. Overcoming regulatory hurdles is key to adopting these innovations for improved patient access and supply chain resilience.

Keywords:
AutomationContinuous processingIndividualized drug therapyPrecision medicinePrinting (3D)Regulatory science

More Related Videos

A High-throughput Automated Platform for the Development of Manufacturing Cell Lines for Protein Therapeutics
07:48

A High-throughput Automated Platform for the Development of Manufacturing Cell Lines for Protein Therapeutics

Published on: September 22, 2011

22.5K
Automated Counterflow Centrifugal System for Small-Scale Cell Processing
04:49

Automated Counterflow Centrifugal System for Small-Scale Cell Processing

Published on: December 12, 2019

9.5K

Related Experiment Videos

Last Updated: Oct 21, 2025

Process Optimization using High Throughput Automated Micro-Bioreactors in Chinese Hamster Ovary Cell Cultivation
09:28

Process Optimization using High Throughput Automated Micro-Bioreactors in Chinese Hamster Ovary Cell Cultivation

Published on: May 18, 2020

8.9K
A High-throughput Automated Platform for the Development of Manufacturing Cell Lines for Protein Therapeutics
07:48

A High-throughput Automated Platform for the Development of Manufacturing Cell Lines for Protein Therapeutics

Published on: September 22, 2011

22.5K
Automated Counterflow Centrifugal System for Small-Scale Cell Processing
04:49

Automated Counterflow Centrifugal System for Small-Scale Cell Processing

Published on: December 12, 2019

9.5K

Area of Science:

  • Pharmaceutical manufacturing
  • Biotechnology
  • Regulatory science

Background:

  • Traditional pharmaceutical manufacturing relies on centralized, mass production models.
  • This rigid system limits innovation, efficiency, and supply chain resilience.
  • Agile manufacturing offers flexibility and decentralization for on-demand production.

Purpose of the Study:

  • To review regulatory barriers hindering agile pharmaceutical manufacturing adoption.
  • To identify emerging opportunities for facilitating agile manufacturing.
  • To propose future-oriented approaches for integrating agile methods into regulatory frameworks.

Main Methods:

  • Literature review of agile manufacturing technologies and regulatory landscapes.
  • Analysis of regulatory challenges in pharmaceutical production.
  • Exploration of collaborative strategies between regulators and manufacturers.

Main Results:

  • Significant global regulatory challenges impede agile pharmaceutical manufacturing.
  • Agile approaches are crucial for personalized therapies and timely medicine access.
  • Advancements in agile-enabling technologies exist across industries.

Conclusions:

  • Collaboration is essential to navigate regulatory complexities for agile pharmaceutical manufacturing.
  • Integrating agile methodologies can enhance efficiency, resilience, and patient access.
  • Future regulatory frameworks must accommodate agile manufacturing principles.