Company Announcements

Rexgenero, a clinical stage regenerative medicine company developing advanced cell-based therapeutics with a focus on Critical Limb Ischemia, announced that it will receive £1.4 million ($1.9 million) in funding for a £1.8 million project ($2.5 million) from Innovate UK. The project is entitled “Cost-driven process redesign, automation and scale-out for commercial manufacture of REX-001 therapy.” Partners in the consortium are the Cell and Gene Therapy (CGT) Catapult, TrakCel and Fisher Bioservices (part of Thermo Fisher Scientific).

In January, Pall, a Danaher company, announced a newly named business unit, Pall Biotech, within Pall Life Sciences. Pall Biotech’s portfolio consists of standard configurable single-use, stainless steel and hybrid technologies for fed-batch and continuous processes across upstream, downstream, and formulation and filling applications.

In February, Pall announced the opening of the $2 million Nanyang Polytechnic Centre of Excellence (NYP) for biologics manufacturing in Singapore. The integrated training center will serve 300 NYP School of Chemical and Life Sciences students annually.

Pall announced in February the opening of an expanded office in Hoegaarden, Belgium. The facility includes 21,528 ft² (2,000 m²) of new office space, in addition to R&D, customer demonstration and manufacturing space. The facility, with over 300 employees, combines three Belgian locations.

In April, Merck KGaA partnered with Oxford University’s Jenner Institute to develop more robust and scalable vaccine manufacturing processes. The partners will improve the manufacturing process for adenovirus vaccines using Merck products, systems and technologies on a real-­world feed stream.

Product Introductions

In March, Sartorius launched the ambr 250, a high-throughput automated parallel bioreactor system, specially designed for rapid cell culture-perfusion process development to optimize production of therapeutic antibodies. It combines 12 or 24 single-use perfusion mini bioreactors (100–250 mL working volume) with associated single-use perfusion components, all controlled by one automated workstation.

Sales and Orders of Note

GE Healthcare announced in January that Clover Biopharmaceuticals has chosen its FlexFactory, a biomanufacturing platform based on single-use technologies, for its new facility in Changxing, Zhejiang, China. The biomanufacturing facility, which will be operational in the latter half of this year, includes two 2,000 L bioreactors from GE.

In March, Sartorius Stedim Biotech announced that ABL Europe has selected the company as its primary supplier of single-use systems. Sartorius Stedim Biotech delivered a comprehensive GMP viral vector manufacturing package solution that included single­use bioreactors and an automation platform for normal flow filtration, tangential filtration and mixing. ABL Europe provides dedicated viral vector GMP manufacturing services for oncolytic, vaccine and gene therapy projects in all stages of clinical development through to commercial launch.

Contract development and manufacturing organization WuXi Biologics announced plans in March to install ABEC’s 4,000 L custom single-run disposable bioreactors at its new commercial manufacturing facility in Wuxi, Jiangsu, China.