Upstream & Downstream Processing

Commercial N-1 perfusion carried out by Samsung BioLogics

CDMO Samsung BioLogics has used an Alternating Tangential Flow (ATF) system to perform N-1 perfusion at its 180,000 L facility in South Korea. Contract development and manufacturing organization (CDMO) Samsung BioLogics opened its number 3 facility at its site in Songdo, Incheon last year, boasting 180,000 L of commercial stainless steel bioreactor capacity. This month, the firm has announced it has successfully carried out N-1 perfusion with an Alternating Tangential Flow (ATF) system at the 3,000 L scale to supply…

From zero to $250m: Agilent aims to dominate cell analysis space

With potentially three acquisitions within nine months, Agilent Technologies has rapidly grown its presence in the cell analysis space and says it aspires to grow further. Technology and services firm Agilent entered the bioanalysis space in 2015 when it acquired manufacturer of instruments and assay kits Seahorse Bioscience. Over the past nine months, Agilent has upped its position in the sector through the purchase of ACEA Biosciences, swiftly followed by the acquisition of Luxcel Biosciences , and just last month…

Dyadic: Deals stack up as industry looks to ‘game-changing’ expression system

Another quarter of deal making by Dyadic International demonstrates how companies are looking to microorganisms instead of CHO to produce affordable drugs, the firm says. Numerous biopharma and biotech firms over the past few years have been turning to Dyadic International to access its C1 fungus-based expression system. The second quarter 2019 was no exception, with Luina Bio, Alphazyme, and the Serum Institute of India inking separate agreements with Dyadic within a two-week period. Such deals reflect Dyadic’s long-term vision…

Sartorius (cell) banks on mammalian manufacturing

Sartorius Stedim Biotech says its newly launched mammalian cell bank manufacturing offering fits hand-in-hand with its existing cell line development services. German bioprocess vendor Sartorius has grown its contract testing and manufacturing services over the past few years, not least through the acquisition of analytics and product characterization firm BioOutsource in 2015. Now the subsidiary Sartorius Stedim BioOutsource will offer the manufacture of GMP master and working cell banks (MCB/WCB) for mammalian suspension cells from its site in Glasgow, UK.…

FDA and NIIMBL partner to advanced biomanufacturing innovation

The US FDA has expanded its partnership with NIIMBL to strengthen biomanufacturing through innovations such as 3D printing and continuous manufacturing. The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) launched in March 2017 to accelerate innovation in biopharmaceutical manufacturing and support the development of standards to drive more efficient and rapid manufacturing capabilities. Institute Director, Kelvin Lee told Bioprocess Insider the institute is already working with the US Food and Drug Administration (FDA) in a variety of contexts –…

GE and Millipore drive ‘exceptional’ quarter for Repligen’s Protein A

Sales in its proteins business grew over 40% year-on-year as Repligen experienced higher than expected demand for Protein A ligands from customers MilliporeSigma and GE Healthcare. Bioprocessing vendor and protein supplier Repligen Corporation reported another record quarter with sales of $71 million (€63 million), up 48% year-on-year. The firm has spent the past few years diversifying its portfolio – and areas of investment in filtration and chromatography, for example, helped drive the quarter – but strong results came from its…

GE: Learning from MAb automation to tackle CAR-T

GE Healthcare says monoclonal antibodies laid the groundwork for its workflow technologies, allowing accelerated uptake of automation in the autologous cell and gene therapy space. In May, bioprocessing tools and services firm GE Healthcare launched its Chronicle automation software for cell therapy manufacturing. The offering supports the complete workflow for cell therapy products including the optimization of manufacturing from process development to commercialization. Talking to Bioprocess Insider at the BPI Theater at BIO in June, Catarina Flyborg, GM of GE’s…

Bemoaning bottlenecks? Put a cork in it! Downstream techs better than ever

Innovative methods and techs have reshaped downstream operations says an industry expert. If you Google “biopharma” and “bottleneck” most results will be articles suggesting upstream technologies have improved faster than those downstream. But the idea of a “downstream bottleneck” is something of a misnomer says Tom Ransohoff from BDO. Instead he argues the upstream gains reflect where innovation efforts have focused. “When antibody and protein titers in mammalian cell culture systems were less 1 g/L several decades ago, the capacity…

On the biotech doorstep: Why Sartorius moved its bioanalytics to Cambridge

Sartorius Stedim Biotech says it consolidated its cell line and testing solutions in Cambridge, Massachusetts to be close to the industry it serves. Services like analytics, QC and characterization, have traditionally been done inhouse. “It was done by what were referred to at one time as testing houses. These were mostly very large QC labs that focused on QC release for firstly traditional pharma products, but that migrated to the biologics,” Maurice Phelan, site head of Cambridge US, Sartorius Stedim…

Danaher: ‘All indications show GE is in wonderful shape’

Danaher Corporation says customers are excited about the combination of Pall Biotech and GE Biopharma as it moves closer to completing the $21.4 billion acquisition. In February, Danaher announced it had reached an agreement to acquire the biopharma division of GE Healthcare for $21.4 billion (€19.1 billion). Danaher first entered the bioprocess space through its $13.8 billion acquisition of Pall Corporation in 2015. This acquisition will, therefore, make Danaher the largest vendor with a fully end-to-end bioprocessing offering. The deal is…