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

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

352
Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
352
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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

216
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,...
216
Bioequivalence: Overview01:16

Bioequivalence: Overview

2.2K
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
2.2K
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

329
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
329
Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

259
As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
259
Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

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

403
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...
403

You might also read

Related Articles

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

Sort by
Same author

Multiplex and Spatiotemporal Detection of Single-Cell Antibody Secretions Using Protein-Patterned Microwells.

Analytical chemistry·2025
Same author

Infliximab and Ustekinumab Clearance Better Predict Endoscopic Outcomes Than Trough Concentrations in Crohn's Disease.

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association·2025
Same author

Endometriosis specific vaginal microbiota links to urine and serum N-glycome.

Scientific reports·2024
Same author

Dietary amino acids, macronutrients, vaginal birth, and breastfeeding are associated with the vaginal microbiome in early pregnancy.

Microbiology spectrum·2024
Same author

Erythropoietin <i>N</i>-glycosylation of Therapeutic Formulations Quantified and Characterized: An Interlab Comparability Study of High-Throughput Methods.

Biomolecules·2024
Same author

Anti-tau intrabodies: From anti-tau immunoglobulins to the development of functional scFv intrabodies.

Molecular therapy. Methods & clinical development·2023

Related Experiment Video

Updated: Apr 3, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
07:25

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

Published on: May 4, 2017

18.3K

Biosimilarity Versus Manufacturing Change: Two Distinct Concepts.

Paul Declerck1, Mourad Farouk-Rezk2,3, Pauline M Rudd4

  • 1Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, University of Leuven, O&N II Herestraat 49, 3000, Leuven, Belgium. paul.declerck@pharm.kuleuven.be.

Pharmaceutical Research
|September 19, 2015
PubMed
Summary

Biologics manufacturing is complex and proprietary, posing challenges for biosimilar development. Evaluating manufacturing changes requires tailored analytical and clinical studies based on the scope of change.

Keywords:
biologicsbiosimilaritybiosimilarscomparability

More Related Videos

Laboratory Scale Production and Purification of a Therapeutic Antibody
09:54

Laboratory Scale Production and Purification of a Therapeutic Antibody

Published on: January 24, 2017

18.5K
Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production
06:18

Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production

Published on: August 18, 2023

3.9K

Related Experiment Videos

Last Updated: Apr 3, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
07:25

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

Published on: May 4, 2017

18.3K
Laboratory Scale Production and Purification of a Therapeutic Antibody
09:54

Laboratory Scale Production and Purification of a Therapeutic Antibody

Published on: January 24, 2017

18.5K
Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production
06:18

Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production

Published on: August 18, 2023

3.9K

Area of Science:

  • Biopharmaceutical Manufacturing
  • Regulatory Science
  • Drug Development

Background:

  • Biologics, derived from living cells, exhibit greater complexity and sensitivity to manufacturing processes than small molecule drugs.
  • Proprietary manufacturing information creates a significant knowledge gap for biosimilar developers.
  • This gap influences regulatory pathways for biosimilarity and manufacturing change assessments.

Purpose of the Study:

  • To elucidate the challenges posed by manufacturing complexity and proprietary information in biopharmaceutical development.
  • To analyze the impact of manufacturing process changes on the evaluation of biosimilars and product quality.
  • To differentiate regulatory requirements for biosimilarity versus post-approval manufacturing changes.

Main Methods:

  • Review of regulatory guidelines and scientific literature concerning biologic manufacturing and biosimilarity.
  • Analysis of the impact of manufacturing process changes on product quality, safety, and efficacy.
  • Comparison of regulatory strategies for demonstrating biosimilarity versus assessing manufacturing modifications.

Main Results:

  • The complexity and proprietary nature of biologic manufacturing present unique challenges for biosimilar development.
  • The scope of manufacturing process changes dictates the extent of analytical and clinical evaluations required.
  • Regulatory approaches for biosimilarity differ from those for assessing manufacturing changes due to inherent knowledge gaps.

Conclusions:

  • Manufacturing process changes in biologics necessitate a risk-based evaluation approach.
  • Quality and analytical studies are often sufficient for minor changes, while major changes may require clinical studies.
  • Regulatory agencies require robust data to ensure biosimilarity and the continued safety and efficacy of biologics following manufacturing modifications.