IND Enabling Tox Batch

Laxai is your preferred partner, strategically positioned to support your IND Enabling Tox batch. Our experienced team skillfully navigates the complexities, ensuring a seamless and successful journey. This pivotal step paves your way to first-in-human trials.

What is IND Enabling Tox Batch?

The IND enabling toxicology batch represents a crucial phase in drug development where specific batches of a drug candidate are produced and tested for toxicity before proceeding to human trials. This process is essential for assessing the safety profile of your potential therapeutic and satisfying regulatory requirements.

Our Expertise

Our core expertise lies in swiftly scaling up by addressing small-scale process challenges. We engage our process development teams early in discovery programs, enabling faster scale-up and quick production of IND-enabling non-GMP toxicology batches, ensuring seamless GMP transition for clinical trials.

Our Offerings

Comprehensive Support

Our experienced team offers comprehensive support for IND tox batches, including scale-up, process safety studies, solid state characterization, and pre-formulation studies.

Advanced Scale-up Facilties

Our Scale-up facilities are equipped with a wide range of reactors from 20 L to 250 L, supported by advanced analytical infrastructure allowing efficient synthesis of high-quality toxicology batches.

Regulatory Insight

Ensuring your toxicology batches meet all regulatory standards for a smooth Investigational New Drug Application (IND) submission process.

Our Process: An Overview

The transition from IND enabling tox batch to First-in-Human batch is a critical step in drug development. Our IND Tox batch services encompass

Analysis And Reporting

Provide comprehensive reports detailing the development and scale-up campaigns

Regulatory Submission Support

Prepare and review documentation required for IND submissions.

Process Development

Develop the process which is scalable, safe and produce consistent quality.

Consultation and Planning

Understand your requirements of IND Tox batch and outline a strategy to effeciently address the challenges in the current process.

Batch Production

Scale up the process to synthesize the Tox batch with the highest quality standards.

A small molecule

CRDMO

Our Services

A small molecule

CRDMO

Our Services

A small molecule

CRDMO

Our Services

A small molecule

CRDMO

Our Services