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

Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

303
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
303

You might also read

Related Articles

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

Sort by
Same author

Long-term outcomes of surveillance or endoscopic therapy for low-grade dysplastic Barrett's according to a selective management algorithm.

Endoscopy international open·2026
Same author

Long-Term Follow-Up of Patients in a Prospective Study of NA Discontinuation Identifies Different Patterns of HBsAg Loss.

Alimentary pharmacology & therapeutics·2025
Same author

Long-Term Outcomes of a Decentralized, Nurse-Led, Statewide Model of Care for Hepatitis C Among People in Prison in Victoria, Australia.

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America·2024
Same author

The History of Flow Chemistry at Eli Lilly and Company.

Chimia·2023
Same author

Endoscopic features of low-grade dysplastic Barrett's.

Endoscopy international open·2023
Same author

Process Development for a 1<i>H</i>-Indazole Synthesis Using an Intramolecular Ullmann-Type Reaction.

The Journal of organic chemistry·2023

Related Experiment Video

Updated: May 6, 2026

High-throughput Synthesis of Carbohydrates and Functionalization of Polyanhydride Nanoparticles
14:37

High-throughput Synthesis of Carbohydrates and Functionalization of Polyanhydride Nanoparticles

Published on: July 6, 2012

11.9K

Kilogram-scale prexasertib monolactate monohydrate synthesis under continuous-flow CGMP conditions.

Kevin P Cole1, Jennifer McClary Groh2, Martin D Johnson2

  • 1Small Molecule Design and Development, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA. k_cole@lilly.com.

Science (New York, N.Y.)
|June 17, 2017
PubMed
Summary

This study developed a continuous manufacturing process for prexasertib monolactate monohydrate, producing 24 kg for clinical trials. The new method enhances safety and containment for potent pharmaceutical compounds.

More Related Videos

Synthesis of Monodisperse Cylindrical Nanoparticles via Crystallization-driven Self-assembly of Biodegradable Block Copolymers
11:42

Synthesis of Monodisperse Cylindrical Nanoparticles via Crystallization-driven Self-assembly of Biodegradable Block Copolymers

Published on: June 20, 2019

8.4K
Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3
08:36

Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3

Published on: April 7, 2023

1.6K

Related Experiment Videos

Last Updated: May 6, 2026

High-throughput Synthesis of Carbohydrates and Functionalization of Polyanhydride Nanoparticles
14:37

High-throughput Synthesis of Carbohydrates and Functionalization of Polyanhydride Nanoparticles

Published on: July 6, 2012

11.9K
Synthesis of Monodisperse Cylindrical Nanoparticles via Crystallization-driven Self-assembly of Biodegradable Block Copolymers
11:42

Synthesis of Monodisperse Cylindrical Nanoparticles via Crystallization-driven Self-assembly of Biodegradable Block Copolymers

Published on: June 20, 2019

8.4K
Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3
08:36

Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3

Published on: April 7, 2023

1.6K

Area of Science:

  • Pharmaceutical Manufacturing
  • Chemical Engineering
  • Drug Development

Background:

  • Pharmaceutical manufacturing is shifting from batch to continuous processing for potent and tailored therapeutics.
  • Traditional batch processing presents challenges for manufacturing highly potent compounds.

Purpose of the Study:

  • To develop and demonstrate a multistep continuous-flow current good manufacturing practices (CGMP) process for producing prexasertib monolactate monohydrate.
  • To produce a sufficient quantity (24 kg) of the drug substance for human clinical trials.

Main Methods:

  • Utilized eight continuous unit operations including reactors, extractors, evaporators, crystallizers, and filters.
  • Operated the process in laboratory fume hoods at a rate of approximately 3 kg per day.
  • Integrated advances in chemistry, engineering, analytical science, process modeling, and equipment design.

Main Results:

  • Successfully produced 24 kilograms of prexasertib monolactate monohydrate suitable for clinical use.
  • Achieved a production rate of approximately 3 kilograms per day.
  • Demonstrated improved performance, safety, and containment compared to traditional batch processes.

Conclusions:

  • A multistep continuous-flow CGMP process is feasible and effective for manufacturing potent pharmaceutical compounds like prexasertib.
  • Continuous processing offers significant advantages in terms of efficiency, safety, and containment for drug manufacturing.
  • The developed process supports the advancement of tailored therapeutics through scalable and safe manufacturing solutions.