Explore recent issues of Contract Pharma covering key industry trends.
Read the full digital version of our magazine online.
Stay informed! Subscribe to Contract Pharma for industry news and analysis.
Get the latest updates and breaking news from the pharmaceutical and biopharmaceutical industry.
Discover the newest partnerships and collaborations within the pharma sector.
Keep track of key executive moves and promotions in the pharma and biopharma industry.
Updates on the latest clinical trials and regulatory filings.
Stay informed with the latest financial reports and updates in the pharma industry.
Expert Q&A sessions addressing crucial topics in the pharmaceutical and biopharmaceutical world.
In-depth articles and features covering critical industry developments.
Access exclusive industry insights, interviews, and in-depth analysis.
Insights and analysis from industry experts on current pharma issues.
A detailed look at the leading US players in the global pharmaceutical and BioPharmaceutical industry.
Browse companies involved in pharmaceutical manufacturing and services.
Comprehensive company profiles featuring overviews, key statistics, services, and contact details.
A comprehensive glossary of terms used in the pharmaceutical and biopharmaceutical industry.
Watch in-depth videos featuring industry insights and developments.
Listen to expert discussions and interviews in pharma and biopharma.
Download in-depth eBooks covering various aspects of the pharma industry.
Access detailed whitepapers offering analysis on industry topics.
View and download brochures from companies in the pharmaceutical sector.
Explore content sponsored by industry leaders, providing valuable insights.
Stay updated with the latest press releases from pharma and biopharma companies.
Explore top companies showcasing innovative pharma solutions.
Meet the leaders driving innovation and collaboration.
Engage with sessions and panels on pharma’s key trends.
Hear from experts shaping the pharmaceutical industry.
Join online webinars discussing critical industry topics and trends.
A comprehensive calendar of key industry events around the globe.
Live coverage and updates from major pharma and biopharma shows.
Find advertising opportunities to reach your target audience with Contract Pharma.
Review the editorial standards and guidelines for content published on our site.
Understand how Contract Pharma handles your personal data.
View the terms and conditions for using the Contract Pharma website.
What are you searching for?
Andelyn will optimize and scale-up the HUB-101 process, generate GMP-grade plasmids, and produce GMP vectors.
October 10, 2024
By: Kristin Brooks
Andelyn Biosciences, Inc., a cell and gene therapy CDMO, has been selected by Hubble Therapeutics to manufacture adeno-associated virus (AAV) using its suspension AAV Curator Platform to manufacture clinical grade AAV for the treatment of Leber Congenital Amaurosis 16 (LCA16) LCA16 is a severe, early-onset retinal dystrophy resulting from mutations in the KCNJ13 gene, which expresses a critical ion channel in the retinal pigment epithelium cells in the retina. Children typically present with visual abnormalities within five years after birth, followed by progressive retinal degeneration during the next two decades of life, ultimately resulting in blindness. HUB-101 has received Rare Pediatric Disease Designation and Orphan Disease Designation from the FDA for this program. Andelyn will optimize and scale-up the HUB-101 process, generate GMP-grade plasmids, and produce GMP vectors that include normal copies of the KCNJ13 gene. From this partnership, Hubble Therapeutics will be able to conduct Phase 1/2 clinical trials with the intention to demonstrate safety and efficacy in an adult patient population. “Over the past 18 months we have identified best-in-class partners including Andelyn Biosciences to establish a gene therapy development program for adult and pediatric patients suffering from Leber Congenital Amaurosis 16 (LCA16),” said Jeff Sabados, President of Hubble Therapeutics. “Andelyn Biosciences has become a global leader in gene therapy development for ultra-rare and orphan diseases and we are grateful for their unwavering commitment toward helping Hubble Therapeutics realize our steadfast promise to support families throughout the world impacted by this devastating genetic disease.” Matt Niloff, Chief Commercial Officer at Andelyn Biosciences said, “We are extremely grateful for the opportunity to produce the clinical grade material for HUB-101 and be a critical part of the pathway for Hubble Therapeutics to demonstrate clinical benefit for the LCA16 program. We are thrilled that our establishment as a top clinical and commercial CDMO is helping to accelerate so many programs like HUB-101 which offer real hope to patients stricken with debilitating diseases.”
Enter your account email.
A verification code was sent to your email, Enter the 6-digit code sent to your mail.
Didn't get the code? Check your spam folder or resend code
Set a new password for signing in and accessing your data.
Your Password has been Updated !