Upstream & Downstream Processing Archives - Page 26 of 38 - BioProcess InternationalBioProcess International

Novasep boosts viral vector offering with access to DNA Flap tech

An agreement between Novasep and Theravectys gives the French CDMO access to the Institut Pasteur’s DNA FLAP technology to produce GMP-grade lentiviral vectors for clinical. The DNA Flap tech allows efficient lentivector-mediated gene transfer either ex vivo or in vitro. It consists of a specific DNA sequence derived from the lentiviral genome, which includes the cPPT and CTS cis-active sequences, required to enable the import of the lentivirus genome into the cell nucleus of non-replicating cells. Theravectys holds a license…

Egg beater: Seqirus goes fully cell-based for seasonal flu vaccine

by Dan Stanton

Seqirus’s vaccine offering for the 2019/20 season will be uniquely cell-base, but the firm says traditional egg-based production still plays a role in fighting influenza. Provided each year by the World Health Organization (WHO) Global Influenza Surveillance and Response System (GISRS), candidate vaccine viruses (CVVs) are the basis for the development and production of seasonal influenza vaccines. For the 2019/20 season, Seqirus has decided to use a cell-based CVV for all four influenza strains recommended by the WHO for its…

CRISPR consortium launched to improve CHO cell lines

by Dan Stanton

Horizon Discovery has launched an industry consortium aimed at improving the CHO expression platform using modern gene-editing tools such as CRISPR and rAAV. At BPI Europe in Vienna, Austria earlier this month, cell line technologies firm Horizon Discovery announced plans to create an industry group to address inadequacies with the prevalent Chinese hamster ovary (CHO) expression platform by using the gene-editing tools CRISPR (clustered regularly interspaced short palindromic repeats) and rAAV (recombinant adeno-associated virus). “The CHO cell line has hardly…

Cell therapy vendors: News from Miltenyi and Saint-Gobain

by BPI Staff

Bellicum Pharmaceuticals has inked a supply agreement with Miltenyi Biotec; Hitachi Chemical has teamed with Saint-Gobain to address manufacturing challenges – welcome to Bioprocess Insider’s cell therapy services round-up. In an SEC filing, Houston, Texas-based cellular immunotherapy firm Bellicum Pharmaceuticals revealed it has entered a agreement with Miltenyi Biotec GmbH for the supply of “certain products in connection with the development and manufacture of certain of the Company’s products.” The firm will pay Miltenyi a €2 million ($2.3 million) upfront…

Encroaching titer, hidden danger: Upstream intensification and the downstream mess

by Dan Stanton

Increased titers are driving the need to move to semi and fully-continuous processing in the downstream, UCB’s Stefanos Grammatikos told BPI Europe delegates. In efforts to intensify bioprocesses and accelerate development, industry has traditionally looked to increasing titers. Since the early days of biomanufacturing thirty years ago, titers have risen from less than 0.5 g/L to mid-to-high single-digits. However, some firms claim they are able to drive titers far higher, either through the use of non-mammalian expression systems (in the…

ChromaCon buy and expansions tip YMC further into the biologics space

by Dan Stanton

Japanese separation resins firm YMC has acquired ChromaCon AG, adding a range of continuous chromatography technologies to its ever-increasing large molecules purification portfolio. The deal, financials of which have not been released, saw YMS acquire 100% of ChromaCon shares and intellectual property rights. This includes patents around multi-column processing, the Contichrom benchtop instrument range of products and several license arrangements. “YMC Process Technologies already manufactures and markets GMP production skids embedding ChromaCon technology,” Philipp Anstätt, strategist aligning R&D and market…

Spin-out Cellular Highways looks to next-generation cell-sorting

by BPI Staff

There is no cell purification technology that allows the selection of cells based on several molecular markers at the same time while processing large batches of cells. That is until the VACS platform, new entity Cellular Highways claims. Tech firm TTP has invested £1.7 million ($2.2 million) in its spin-out firm Cellular Highway in efforts to commercialize the Vortex-Actuated Cell Sorting (VACS) platform. Bioprocess Insider (BI) spoke to Salman Samson Rogers (SSR), CEO of the new entity to find out…

Quality FBS, or just BS? Industry turning to supply chain certification

by Dan Stanton

Fetal bovine serum (FBS) is the gold standard for growth media but poor quality and counterfeit product pose risks to manufacturing and the patient. Traceability audits and origin determination test can overcome these, says the ISIA. FBS has been used as a culture supplement for the past 65 years and is unlikely to be rivalled in its growth promoting capabilities for some time, Brian Lewis, a representative from the International Serum Industry Association (ISIA) and president of BL Consulting, told…

Merck to up drug product capacity by 50% at Swiss site

by Dan Stanton

Merck KGaA will invest €150 million ($168 million) to build a facility with two new aseptic filling lines at its site in Aubonne. For Germany’s Merck, the Aubonne site in Switzerland is its global center of expertise for the production of biotech drug products, carrying out both aseptic filling and packaging operations. The €150 million investment will cover a new building with two new lines for the aseptic filling – one for freeze-dried formulations, one for liquid formulations – of…

Rockwell incident: GE collaborates on automation tech

by Dan Stanton

GE Healthcare will demonstrate automated single-use bioprocessing technologies at Interphex this week after teaming up with Rockwell Automation. Ahead of the Interphex event in New York City this week, GE Healthcare has announced a collaboration with Rockwell Automation, combining automation, IT and single-use technologies in efforts to create more flexible and faster facilities. “We are working with Rockwell to develop innovative solutions that address single-use bioprocessing challenges,” Kevin Seaver, executive general manager of Bioprocess Automation and Digital at GE Healthcare…