Upstream & Downstream Processing

rBIO launches aiming to increase manufacturing output of insulin

rBIO plans to lower cost of insulin by 30% through the ‘hyper-expression’ of newly-developed strains of bacteria. The start-up company is launched out of San Francisco and arrives alongside the news that it has successfully synthetically produced human insulin, using E. coli bacteria as the host for recombinant DNA synthesis. According to rBIO, the next stages for the biotech are to upscale production of insulin and to identify other prescription drugs that can be manufactured using its approach. Already the…

Sartorius: $36m WaterSep buy to further boost filtration ambition

Sartorius will bolster its downstream offering by adding hollow‑fiber membrane manufacturer WaterSep BioSeparations. The deal comes a month after Sartorius closed its €360 million acquisition of BIA Separations, Bioprocess vendor Sartorius Stedim Biotech announced this week it will pay $27 million for Marlborough, Massachusetts-based purification firm WaterSep BioSeparations, with a further $9 million to be paid depending on a defined sales revenue growth by 2023. WaterSep makes hollow-fiber membrane devices and pre-sterilized assemblies for upstream and downstream biopharmaceutical applications. “The…

MilliporeSigma accelerates $47m expansions on back of COVID surge

MilliporeSigma has expedited planned capacity expansions at sites in Massachusetts and New Hampshire after seeing a surge in demand for bioprocess equipment from coronavirus therapy and vaccine developers. The Jaffray, New Hampshire facility manufactures single-use components and filtration equipment for biopharma manufacturers. Having added 38,500 square feet of production space last year, MilliporeSigma is now moving forward with a $22 million 25,000 square-foot expansion, adding new production lines and equipment. Concurrently in Danvers, Massachusetts, a 65,000 square-foot expansion – representing…

Cell therapy process control requires a rethink, says expert

Autologous cell therapy production is a challenge and control strategies developed for protein drugs may not work, says an expert. The biopharmaceutical industry has been making therapeutic proteins for forty years. The unit operations and methods are well established and effective. Firms know how to control production to ensure the finished medicine is of appropriate quality. Industry has less experience making therapies from cells harvested from patients and this is a problem according to Rachel Yost, senior process engineer at…

64x claims cell screening tech is breakthrough for global vector supplies

64x bio says a new cell screening technology has the potential to make viral vector production more efficient. The San Francisco-headquartered biotechnology’s “VectorSelect” platform is a high throughput screening technology designed to help viral manufacturers identify high yield production cell lines. 64x bio says the system’s key feature is “genetic barcoding,” which links information on viral vector productivity to the parent cell allowing users to screen millions of candidate production cell lines at once. The aim is to help firms…

Hyasynth harnesses biopharma processes bringing yeast-made CBD to market

Using yeast fermentation in a similar way to insulin synthesis provides a cheaper, more sustainable way to make cannabinoids like CBD, says Hyasynth. Last month, Canadian firm Hyasynth received a $2.5 milllion milestone payment for its commercialization achievements in being first-to-market with cannabidiol (CBD) produced and extracted from a biomanufacturing setup. “It’s a typical yeast fermentation, so the equipment involved would be similar to the production of insulin,” Kevin Chen, CEO of Hyasynth told this publication. “We grow the yeast…

Repligen up on COVID-19 and gene therapy related demand

COVID-19 related demand helped Repligen in Q3 with the emerging gene therapy sector also providing a revenue boost. The processing technology firm’s revenue reached $94.1 million for the three months ended September 30, up 35% year-on-year. Gross profits also increased, climbing 40% to $54.5 million. Repligen attributed the gains to increased demand for its technologies from companies working on SARS-CoV-2 vaccines or related therapeutics. CEO Tony Hunt told analysts “We estimate that COVID programs accounted for approximately 55% of our…

Test continuous manufacturing tech with real processes, says expert

Continuous processing technologies and methods should be tested with actual production processes says Tom Ransohoff from CDMO 4th Dimension Bioprocess. Continuous-mode manufacturing has been a hot topic for the drug industry for the past few years but, as yet, few companies have fully embraced the approach and even fewer have switched from fed-batch production. But the change is coming according to Tom Ransohoff, COO at recently founded CDMO 4th Dimension Bioprocess, who told delegates at the BPI East conference in…

ELEVECTA – The future of AAV gene therapy vector production

Pharmaceutical companies with gene therapies in their pipeline need to establish scalable production processes that can keep up with the increasing demand in terms of volume, quality and robustness, says CEVEC. Gene therapies are seen as one of the most promising approach to treat life-threatening diseases with no therapeutic options and high medical needs.  In addition, gene therapies are now advancing also into indications with larger numbers of patients, including Alzheimer’s and Parkinson’s, thereby dramatically increasing the demand for viral…