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The latest advances in downstream technologies include sterile disconnects for single-use manufacturing systems, ligand technologies for purifying RNA and for COVID-19 vaccines, and an automated perfusion system.
Biopharmaceutical downstream processing and cell and gene therapy manufacturing is moving toward greater use of single-use technologies and automation, as well as developing continuous, automated processes. The following are a sampling of products developed to enhance the bioprocessing industry.
The new HFC Disconnect Series from Colder Products Company (CPC) allows simple and fast disconnection of tubing within single-use biopharma and cell and gene therapy (CGT) manufacturing systems (1). Applications include flexible tubing used with storage/mixing tanks, single-use bioreactors, transfer lines, chromatography skids, filters, sampling, and freeze/thaw bags.
A thumb latch disconnects the single-use system and maintains a sterile fluid path on both sides, while a protective latch cover prevents accidental disconnection. The HFC disconnects require no additional equipment for sterile disconnection.The series is offered as separate connector bodies and inserts or as ready-to-install sets that fit 1/4 in., 3/8 in., and ½ in. inner diameter tubing.
“The HFC’s simple-to-use design helps reduce operator error, streamlines staff training and enables consistent point of disconnect when designed into the single-use system,” said Maria Bollensen, CPC product manager, in a company press release. “We’re supporting the speed, flexibility, and quality that biopharma and CGT manufacturers demand in their operations.”
PrimaS ligand technology from BIA Separations is a multi-use platform that enables high-resolution and high-speed processing while focusing on the separation problems of advanced therapy medicinal products (2). Part of the company’s mRNA purification toolbox, the platform is equipped for dsRNA impurity removal and mRNA sizing options and is scalable from lab to manufacturing.
Navigo Proteins and Repligen developed an affinity ligand targeting the SARS-CoV‑2 spike protein for the purification of COVID-19 vaccines (3). The program is currently in stage two, which will focus on the development and validation of a related affinity chromatography resin to serve as a rapid, high purity capture step to reduce processing time and improve yield during the manufacturing of COVID-19 vaccines. The final resin product is expected to be commercially available in early 2021.
“This joint endeavor is the logical continuation of our journey to develop platform-based purification solutions for biopharmaceutical downstream processing,” said Dr. Henning Afflerbach, CEO of Navigo Proteins, in a press release. “Our affinity chromatography technology—Precision Capturing—is a solution to cope with ever-increasing regulatory and capacity requirements of the entire biopharmaceutical manufacturing industry, including vaccines.”
Cytiva’s Fibro PrismA, a product based on Cytiva’s new protein A fiber chromatography technology, was introduced in 2020 and is already being used to accelerate research (4). Two versions of the product, HiTrap Fibro PrismA and HiScreen Fibro PrismA, are commercially available for research and process development.
With the ability to rapidly cycle antibody purification, Fibro PrismA can support up to 20 times increased throughput compared with traditional resins. Using the full unit lifetime in a single batch makes it efficient for single-use operations.
“Speed and flexibility are what our customers need to advance the development of novel therapeutics,” said Olivier Loeillot, senior vice president, Bioprocess, Cytiva, in a company press release. “Fibro PrismA enables ultrafast purification in research and process development allowing researchers to accelerate the drug discovery process.”
1. Colder Products Company, “New CPC Solutions Simplify Secure Biopharma Fluid Handling,” Press Release, Sept. 22, 2020.
2. BIA Separations, “BIA Separations Introduces Primas Multi-Mode Ligand Bioprocessing Technology to Facilitate Development of Advanced Therapeutics,” Press Release, June 16, 2020.
3. Navigo Proteins, “Navigo Proteins and Repligen Announce Achievement of a Key Milestone in Development of an Affinity Resin for the Purification of Covid-19 Vaccines,” Press Release, Oct. 1, 2020.
4. Cytiva, “Cytiva’s Fibro PrismA Technology Accelerates mAb Purification in LifeArc’s Covid-19 research,” Press Release, October 8, 2020.
Lauren Lavelle is the assistant editor for BioPharm International.
Vol. 33, No. 11
When referring to this article, please cite it as L. Lavelle, “What’s New in Downstream Technologies,” BioPharm International 33 (11) 2020.