The application for investigational new drug (IND) and Clinical Trial Application (CTA) is a key step in initiating clinical trials/first-in-human (FIH) trials for a drug candidate. Furthermore, its approval can help companies secure additional funding and facilitate pipeline generation. However, pre-clinical toxicology studies can present a bottleneck for companies on the path to FIH. Accelerating their timelines through rapid toxicology material delivery can be an effective way to reduce a drug candidate’s time to enter the clinic. Read more in the article.
You may also be interested in:
Mammalian
Parenteral Drug Product
Monoclonal Antibody
Cell Line Development
Author(s):
Alejandro Fernandez-Martell
Principal Scientist, Global Process Development
James Berrie
Technical Director, Global Process Development
By clicking "Access Content" you agree to our Legal Disclaimer and the Lonza Privacy and Cookies Policy.

Latest content
Latest briefing from the Knowledge Center
e-book
Experts in Expression: Recent Advances in CHO Upstream Bioproduction
Constantly evolving biopharmaceutical pipelines require continuous evolution of CHO-based...
Article
Powering the Development of Tomorrow’s Bispecific Antibodies
bYlok® technology is changing the way bispecific antibodies are designed. Achieving the correct...
Webinar (on-demand)
Tech Transfer Strategies and Best Practices to Optimize Your Clinical and Commercial Supply
Tech Transfers for biological products, whether they occur from a pharma company, another CMO, or a...
White paper
Exploring Technologies for cGMP Success with Encapsulation of Nucleic Acid-based Therapeutics
In this white paper, we discuss the challenges and opportunities associated with nucleic acid...
Presentation (slides)
From Lab to Large-Scale Process Validation: Mastering Regulatory Requirements
Start with the end in mind: Meticulous planning of CMC activities is a cornerstone of success to...
White paper
Mastering Biologics Tech Transfers: Key Success Factors
Tech transfers play a vital role in ensuring that medicines reach patients on time. This article...
mAb
Article
Creating Next-Generation CHO Expression Platforms Through Application of Omics Technologies
Chinese hamster ovary (CHO)-based biomanufacturing platforms have transformed the industrial...
microbial yeast cells - blue
R&D Blog post
Leveraging the potential of XS® Pichia Expression System
One of the most important goals of genetic engineering, especially within the biopharmaceutical...
White paper
An Integrated End-to-End Approach to Antibody Drug Conjugate Development and Manufacturing
Antibody drug conjugates (ADCs) are revolutionizing cancer therapy with their highly specific...
man working with microscope in lab,Process Development,Biologics_Slough_18,,lab in slough,tech working in lab with computer,male tech pipetting,tech holding vial,tech working,Cell Iine process development,biologics lab worker, ,Biologics_Slough_29,Biologics , Biologics Slough
Webinar (on-demand)
Innovative Solutions for Enhancing Biotherapeutic Expression and Development
The range of molecular formats being explored in drug discovery and development has expanded far...
man working with microscope in lab,Process Development,Biologics_Slough_18,,lab in slough,tech working in lab with computer,male tech pipetting,tech holding vial,tech working,Cell Iine process development,biologics lab worker, ,Biologics_Slough_29,Biologics , Biologics Slough
Article
Accelerating the Path to Clinical Filing Applications with Rapid Toxicology Material Delivery
The application for investigational new drug (IND) and Clinical Trial Application (CTA) is a key...
mAb
Article
Rapid Delivery of Toxicological Material
With increasingly rapid timelines for achieving IND-ready processes, a bottleneck has emerged in the...