Author Archives: Millie Nelson

AES Clean Technology to build $14.2m Pennsylvania plant

AES says it will be able to meet current and future cleanroom demand through the construction of a facility in Lancaster County, Pennsylvania, AES Clean Technology, a provider of cleanroom facilities within the pharmaceutical and biopharmaceutical industry said the facility will expand its production capabilities to match industry growth, especially for clients responsible for the production of COVID-19 treatments and advanced bio-therapeutics. “We see several factors that are driving the decision to add this new capacity. There is a real…

Recipharm takes first step in DS biologics with GenIbet buy

Through the acquisition of Portuguese CDMO GenIbet Recipharm will move into the biologics drug substance manufacturing space for the first time.   The Swedish contract development manufacturing organization (CDMO) has traditionally been in the small molecule and fill-finish space, as well as expanding its biologics drug product offering in February 2021 by extending its manufacturing license to include immunology products at its facility in Wasserburg, Germany. Now, Recipharm steps into biologics drug substance manufacturing through the acquisition of Genlbet, a…

Regeneron, Lilly to adjust capacity after FDA halts COVID-19 treatments

The US FDA has revised the emergency use authorizations for Regeneron and Eli Lilly’s COVID-19 antibody treatments after the drugs proved ineffective against the omicron variant. Eli Lilly’s monoclonal antibody (mAb) treatments – bamlanivimab and etesevimab (administered together) and Regeneron’s REGEN-COV (casirivimab and imdevimab) will be limited to use only “if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments,” the US Food and Drug Administration (FDA) said…

Univercells and RoosterBio target regen med commercialization

The partnership aims to enhance manufacturing of extracellular vesicles (EVs) using continuous bioprocessing technologies to make regenerative medicine cheaper. The aim of the collaboration is to deliver exosome manufacture, using Univercells’ scale-X hydro fixed-bed bioreactor and RoosterBio’s human mesenchymal stem/stromal cells (hMSC) bioprocess and engineering media systems to establish EV produ ction. “A first step will be to evaluate the performance of the EV manufacturing process in the scale-X bioreactor and benchmarking it against a reference process (microcarriers process in the…

2021 CGT moments: First place for second line CAR-T

Advancements in CAR-T development and access, in vivo gene editing, and CDMO M&A all feature in Propel BioSciences’ Susan Nichols top 10 advanced therapy moments of 2021.  After two years away, BioProcess Insider attended the highly anticipated presentation at Phacilitate’s Advanced Therapies Week in Miami, Florida, where Susan Nichols (CEO of Propel BioSciences) highlighted 10 moments from 2021 that defined and drove the cell and gene therapy (CGT) space.  Some unexpected milestones made the list, such as the arrival of messenger…

eBook: Antibody–Drug Conjugates —
A New Generation of Approaches Is Changing the Game

Combining large proteins with linkers and cytotoxins, antibody–drug conjugates (ADCs) may be the most complex drug molecules in development today. Despite early promise and product approvals, a number of technical concerns arose during product and process development. Characterizing and ensuring consistency in the number of small molecules that attach to the antibody — as well as ensuring their proper attachment and biophysics — all present significant challenges to ADC developers. Solving early problems associated with product quality has introduced a…

64x Bio bags $55m in funding to drive cell production tech

64x Bio has received $55 million in a series A round of fundraising to fund the expansion of its VectorSelect platform. According to 64x Bio, a synthetic cell and gene therapy (CGT) manufacturer founded in 2020 and focused on addressing CGT manufacturing issues exposed by the Coronavirus pandemic, its cell line engineering technology, VectorSector has the potential to revolutionize the economics and accessibility of gene therapy. Led by Lifeforce Capital, with contribution from Northpond Ventures, Future Ventures and others ,…

Orgenesis and Johns Hopkins University to build CGT Maryland Center

Orgenesis and Johns Hopkins University will build a cell and gene therapy processing facility in Maryland, US for point of care treatment. The 7,000 square-foot POCare Center, also known as the Maryland Center for Cell Therapy Manufacturing, has been partly funded by a $5 million grant from the State of Maryland with building expected to start in Q2 2022 and the facility anticipated to be operational by Q2 2023. “Orgenesis is a pioneer of decentralized processing and production of CGTs,…

Continuous processing and CGTs: MilliporeSigma on CDMO trends for 2022

BioProcess Insider spoke virtually with MilliporeSigma’s head of Process Solutions Andrew Bulpin about his predictions for the company and the CDMO space in 2022. The life sciences services division of Merck KGaA, MilliporeSigma, has been steadily increasing its contract development manufacturing organization (CDMO) services through a string of investments and expansions. The firm invested $110 million into its gene therapy CDMO business in April 2020 by building a second facility at its site in California, adding 11 production suites and more…

Cytiva and Nucleus team on custom cell media for CGTs

The collaboration with Nucleus Biologics will provide transparent and scalable manufacture of custom cell culture media, says Cytiva. Under the terms of the deal, Cytiva and cell culture firm Nucleus Biologics have partnered to develop custom media formulation and fulfillment solutions for the cell and gene therapy (CGT) space. Cytiva customers will be able to formulate their own custom cell culture media through Xuri Media AI Guide, which is based on Nucelus’ NB-AIR platform. Additionally, clients can configure their media…