When you see IND on the horizon, look to us.

As your product nears the IND application process, the need for spot-on preclinical accuracy and comprehensiveness is paramount. That’s where we help our partners thrive.

Preclinical Services

We determine the safety profile of your product through robust in vitro and in vivo testing. Our cost-effective methodologies adhere to all U.S. guidelines and regulations in accordance with GLP, ICH and the FDA. And our toxicity program is designed to offer the most appropriate species for characterizing your protein’s safety profile in mammals. CLICK HERE TO LEARN MORE >

CIAO!™

What about production feasibility? We can help here, too. We engineer your molecules to obtain the highest manufacturing yields using CIAO!™ – our proprietary Comprehensive Integrated Antibody Optimization platform that reduces downstream challenges and costs by designing into the protein the features important for manufacturing and process development – from day one.
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Preclinical and Manufacturing Services Overview

In vivo Pharmacokinetic (PK) and Pharmacodynamic (PD) Trials

to quantify the bioavailability, biodistribution, and bio-equivalence of your drug. Pharmacodynamic studies can provide evidence that your protein produces the desired pharmacological effects.

In vivo Toxicology

services measure Maximum Tolerated Dose (MTD), acute and subchronic toxicity, single and repeated dose effects, sensitization and irritation levels.

Multiple Animal Species

are available to align with your required testing data including mice, rats, hamsters, guinea pigs, rabbits, dogs, and non-human primates.

Follow-On Biologics

encompass both Biobetter and Biosimilar molecules. Our powerful expression optimization technology for Biosimilar products enables low cost, efficient production. Our suite of engineering technologies also provides best-in-class next generation Biobetter molecules.
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Ask us about:

  • Our customers’ preclinical success stories and resulting Clinical Trials (2011)
  • Our ongoing business relationship with FDA specialists that helps facilitate a smooth preclinical process for our clients
  • Our multi-hundred liter scale microbial manufacturing for research use

Let’s talk. Call us at 858-558-0708 ext. 0 for information, planning and pricing.