Rentschler to Produce Apeiron's Monoclonal Antibody APN311 - - BioPharm International

ADVERTISEMENT

Rentschler to Produce Apeiron's Monoclonal Antibody APN311



Apeiron Biologics AG, and Rentschler Biotechnologie GmbH announced a partnership agreement to manufacture GMP material for various advanced clinical studies and later on for market supply of Apeiron’s lead program, APN311.

APN311 is a chimeric antibody that targets the GD2 antigen, which is abundantly expressed on neuroblastoma cells. The program is currently being evaluated in several clinical trials in patients with high-risk neuroblastoma, the most common extracranial solid tumor seen in children.

Decisive factors in Apeiron’s partnering selection were Rentschler’s ability to keep the very challenging project timelines and their technical and regulatory expertise in phase III and market projects, the company reports. Apeiron receives access to experienced teams, appropriate mammalian cell culture capacity for clinical phase I to III and commercial production, fill and finish services as well as a scientific-driven and responsive project management. The partnership agreement includes the transfer of the manufacturing process to Rentschler, GMP manufacturing, and process validation in preparation of the MAA/BLA submission as well as future market supply.

Source: B3C Newswire

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

First Biosimilar Application Kicks Off Legal Battle
October 31, 2014
FDA Approves Pfizer's Trumenba for the Prevention of Meningitis B
October 30, 2014
EMA: Extrapolation Across Indications for Biosimilars a Possibility
October 30, 2014
Bristol-Myers Squibb Announces Agreement to Acquire HER2-Targeted Cancer Treatment
October 29, 2014
Amgen, Sanofi, and Ono Pharmaceuticals Partner with Universities on Transmembrane Protein Research
October 28, 2014
Author Guidelines

Click here