Our customers are the real rock stars--the ones playing by their own (FDA- and EMA-compliant) rules. We really geek out on this stuff, from making curative gene therapies, to vaccinating the world against COVID, to building a bank of bacteria-battling viruses.
Moderna is using a Vanrx SA25 Aseptic Filling Workcell at its Norwood, Massachusetts site for clinical trial supply manufacturing and product development. Their facility won the 2019 International Society of Pharmaceutical Engineering (ISPE) Facility of the Future Award.
Roche / Genentech adopted the SA25 Aseptic Filling Workcell as the global flexible filling platform to meet the current and future needs of their pipeline.
Locus Biosciences is taking the fight to antibiotic resistant bacteria using CRISPR-Cas3 gene edited phage therapies. Paul Garofolo and Nick Conley tell the story of how in-house manufacturing gave them control.
Singota Solutions recognized that companies developing new drug products and needing to fill batches of 20,000 units or less were underserved by contract manufacturing organizations. They chose Vanrx’s SA25 Aseptic Filling Workcell to provide an agile filling service for vials, syringes and cartridges, with short lead times.
WuXi Biologics installed the SA25 Aseptic Filling Workcell at its DP4 drug product operations, reaching its first GMP batch release 15 months after purchasing the machine in 2018. As of April 2020, WuXi Biologics is filling vials, syringes and cartridges for clients at clinical and commercial levels with a quality acceptance rate up to 99.5% of units produced.
Adaptive Phage Therapeutics (APT) is developing PhageBank, a collection of viruses to kill the most dangerous antibiotic resistant superbugs. Their challenge is to fill multiple viruses every day in building a library of 1,000+ drug products. APT needed a highly agile vial filling system and chose Vanrx’s Microcell Vial Filler to accelerate the process.
“ADMA Biologics is a manufacturer of life saving, FDA approved plasma derived immune globulin biologic products. Vanrx has helped us move quickly to receive and install our new filling machine, the SA25 Aseptic Filling Workcell during the COVID-19 crisis. We believe the SA25 is an easy-to-use, all-in-one solution for our in-house aseptic filling requirements and will allow ADMA to bring our products to patients faster, improve our margins, as well as substantially increase our end-to-end control over our manufacturing process.”
Adam Grossman
President and CEO
Seven months after their purchase order, ADMA Biologics completed the site acceptance test of an SA25 Aseptic Filling Workcell. Adam Grossman, President & CEO of ADMA Biologics, commented on the milestone:
“We [FUJIFILM and Vanrx] are a good match in terms of how we like to work and our ultimate goal: to improve patient outcomes and patient access.”
Thomas Page
VP, Engineering and Asset Development, FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth sought aseptic filling technology that could reduce risk in producing high-value gene therapies. The company has gone on to add a second SA25 Aseptic Filling Workcell for recombinant protein manufacturing at its College Station, Texas facility.
Emergent BioSolutions transitioned existing commercial drug products from conventional filling in an open Grade A cleanroom to the SA25 Aseptic Filling Workcell. Read about their experience, including technology evaluation, validation and new primary packaging components.
“Vanrx’s invention of a gloveless isolator represents a paradigm shift.”
Dr. Nitin Rathore
Director of Process Development, Amgen
In a presentation at AAPS PharmaSci 360, Amgen reviewed how Vanrx’s SA25 Aseptic Filling Workcell could help meet business needs in an environment of high-mix, low-volume manufacturing.
“Utilizing pre-sterilized, ready-to-fill nested vials, full robotic manufacturing and incorporating automation in-process controls and environmental monitoring, brought an answer to all our requirements. The user-friendly interface makes the machine an absolute pleasure to work with. It empowered us with flexibility and agility in small batch aseptic manufacturing, even when working with dangerous substances,” says Dr. Cobus Raath, Managing Director.