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AUSTIN, Texas – April 3, 2021 – Altogen Labs today detailed its biocompatibility testing services, extending the company’s preclinical safety capability to medical device developers and sponsors of drug-device combination products.
Device and combination product development follows a different regulatory path than small molecules, but it rests on the same foundation: demonstrating that materials in contact with tissue do not produce unacceptable biological responses. Cytotoxicity, irritation, and sensitization assessments form the core of that evidence base.
Altogen Labs supports this work with cytotoxicity testing by MTT, LDH, and live/dead assays, genotoxicity evaluation by micronucleus and comet assays, and in vivo assessments including acute dermal toxicity and acute dermal irritation conducted to OECD guidelines. Cell-based assay development covering apoptosis, cell cycle, viability, and ATP endpoints allows sponsors to characterize mechanism where a signal is detected.
The company notes that in the early stages of drug or medical device development, a large volume of analytical data must be acquired to validate the usefulness of a product. Preclinical studies establish biological plausibility, define dosage levels, demonstrate safety, support patient eligibility criteria, and may identify potential public health risks — work that shapes the entire subsequent development pathway.
All studies are conducted at the company’s GLP-compliant, IACUC-regulated Austin, Texas facility, with complete documentation delivered to the sponsor.
About Altogen Labs
Altogen Labs is a professional, experienced, and highly reputable GLP-compliant contract research organization providing preclinical research and biology CRO services worldwide, with a large collection of in-house validated xenograft models (CDX, PDX, syngeneic, organoids, NAMs) and extensive experience in efficacy xenograft studies and safety toxicology studies.
Contact Information:
Altogen Labs | 11200 Menchaca Rd, Bldg 2, Suite 203 | Austin, TX 78748 USA Tel: 512-433-6177 | Email: info@altogenlabs.com | Web: altogenlabs.com