Author Archives: Millie Nelson

Moderna recalls another lot of COVID-19 vax

Moderna has recalled one lot of its COVID-19 vaccine, Spikevax, after a foreign body was found in a vial produced by CDMO Rovi.   Moderna and Spanish contract development manufacturing organization (CDMO) Laboratorios Farmacéuticos Rovi jointly announced that they have recalled lot #000190A of Spikevax in Europe, which consisted of 764,900 doses. The firms were made aware of the issue through a product complaint from a vaccination center based in Malaga, Spain. The dose in question was returned for forensic…

Trade secrets theft: ‘Unfair to the innovator, unfair to the industry’

Two co-founders of Taiwanese firm JHL Biotech were sentenced last month for plotting to steal trade secrets from Genentech and commit wire fraud exceeding $101 million. BioProcess Insider spoke to the attorneys who represented Genentech in this landmark civil and criminal case. According to the suit, the story goes back thirteen years where former principal scientist Xanthe Lam and her husband, Allen Lam, conspired to commit stealing trade secrets from Genentech and passing the information to Taiwanese company JHL Biotech (now Eden…

GSK site revamp reportedly on ropes; PE blames lack of Gov commitment

After receiving permission to build a £350 million biomanufacturing facility at a former GSK site in Ulverston, UK last year, Lakes BioSciences’ plan has reportedly fallen through. In February 2021, contact development manufacturing organization (CDMO) Lakes BioScience was granted permission from South Lakeland District to build a facility on GlaxoSmithKline’s (GSK) site located on North Lonsdale Road, Ulverston, Cumbria. Lakes BioScience director, Pat McIver told BioProcess Insider at the time that £350 million ($490 million) was being invested to build a monoclonal…

Lonza adds magnetic cell selection to Cocoon platform

Lonza has expanded its Cocoon platform functionality by adding capabilities in cell separation, cell binding, and bead removal. The Cocoon platform is a single system that can be used for a wide-range of different autologous cell therapy protocols, with each patient batch produced in a single disposable cassette customized to their specific process. The platform was developed by Octane Biotech with help from Swiss contract development manufacturing organization (CDMO) Lonza, which has worked with the firm since 2015. In October…

ThermoGenesis entering the CDMO space

ThermoGenesis has leased a facility in Sacramento, California to house its newly launched CDMO cell therapy business TG Biosynthesis.  ThermoGenesis (formerly known as Cesca Therapeutics), which provides cell processing tools and services to the cell and gene therapy sector, is bolstering its offering by creating a cell therapy production division.   The firm will deliver contract development manufacturing organization (CDMO) services under the name TG Biosynthesis. To create this, ThermoGenesis entered into a license and technology agreement with Boyalife Genomics, a…

Abzena bags $65m to expand manufacturing capacity

Abzena has secured $65 million in additional funding to expand its production facilities to meet the increased demand in the industry. Contract development manufacturing organization (CDMO) Abzena says the latest investment from Welsh, Carson, Anderson & Stowe, and Biospring Partners will allow the firm to meet growing demand by increasing the capacity of its manufacturing capabilities for clinical and commercial supply. “At Abzena, we put patients at the center of all that we do. This new capital will allow us…

UK reports 9% yearly growth in CGT clinical trials

CGT Catapult says the UK is a “world leader” in developing advanced therapies after publishing a 2021 clinical trials database and report. The Cell and Gene Therapy Catapult (CGT Catapult) says its Advanced Therapy Medicinal Product (ATMP) 2021 clinical trials report has highlighted a period of continued growth in both the amount and progress of trials being conducted in the UK. “In the UK, just under 80% of ATMP clinical trials are commercially sponsored, an increase of 13% over the…

Exothera further expands its viral vector capacity

The CDMO has expanded its facilities by a further 22,600 square feet to relieve its capacity constraints. Contract development and manufacturing organization (CDMO) Exothera was founded in March 2020 by Belgium-based bioprocess tech firm Univercells, to offer cell and gene therapy developers process development and viral vector manufacturing. After expanding its two facilities in Jumet, Belgium about 25 km south of Brussels, and selecting bioprocess vendor Pall Corporation to equip the roughly 92,000 square feet of space in July 2021,…

eTheRNA launches LNP Service

eTheRNA Manufacturing introduces a lipid nanoparticle (LNP) formulation development and production service to support the discovery and early pre-clinical advancement of RNA-based therapeutics and vaccines. According to the RNA technology firm, the LNP service uses eTheRNA’s lipid libraries and formulations to enable targeted delivery and tailored biodistribution solutions. Additionally, the service has been developed to allow customers to maximize the delivery of their RNA-products. “This service can cover product needs for early research and development and can be further optimized…

Swiss CDMO expands drug product plant

ten23 health will add 1000 square meters at its site in Visp, Switzerland by expanding into an adjacent building. The contract development manufacturing organization (CDMO) acquired its Visp, canton of Valais, Switzerland manufacturing site from swissfillon last October. Now, the firm will add 1,000 square meters of clean room space to enlarge its cold storage and visual inspection capacity. “ten23 health needs to increase the supporting infrastructure in order to utilize our assets for sterile production in Visp,” a spokesperson…