Upstream & Downstream Processing

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…

Sartorius to open Massachusetts customer interaction center

The facility will serve as a focal point for Sartorius’ US customers to test and discover bioprocess solutions for their biopharma projects. To be known as the Customer Interaction Center (CIC), the facility in Marlborough, Massachusetts will serve as a center of excellence for Sartorius. “The new site will be a focal point for customers in what is now one of the world’s largest development hubs for biopharmaceutical products,†the firm said. The 40,000 square-foot facility aims to optimize factory…

Repligen strengthens downstream offering with $200m ARTeSYN acquisition

Repligen says it has established itself as a premier player in single-use systems, integrated flow paths, and assemblies following a triumvirate of bolt-on acquisitions. According to Repligen Corporation, ARTeSYN Biosolutions’ single-use chromatography and filtration systems are considered “the gold standards in downstream bioprocessing.†The technologies – along with three manufacturing facilities in Ireland, Estonia, and California – are soon to become part of Repligen’s offering after the firm entered a definitive agreement to buy ARTeSYN for $130 million cash and…

Pall and Cytiva reaping $1bn coronavirus bonus for Danaher

Danaher Corporation says its bioprocessing businesses Pall Biotech and Cytiva have secured over $1 billion in COVID-19 related orders and expects further windfalls as vaccines and therapies reach approval. When the coronavirus pandemic emerged earlier this year, commentators noted the financial opportunity for bioprocess vendors in supporting industry’s efforts in developing and commercializing vaccines, therapeutics, and diagnostics. As the year progresses, these opportunities are materializing in quarterly statements, with Danaher Corporation the latest company showing a COVID-19 tailwind across its…

Sartorius revises 2020 forecast on bioprocess solutions and lab services growth

Sartorius has raised its guidance citing growing demand for bioprocessing tech and lab services and the positive impact of acquisitions. Group revenue for the nine months to the end of September was €1.68 billion, up 23.9% on the comparable period last year. Bioprocess Solutions generated €1.28 billion, up 27.7%, while laboratory products and services brought in €391 million, up 13%. Sartorius said a general increase demand and the positive impact of recent takeovers were the major drivers. The COVID-19 pandemic…

Single-use tech helps give emerging biotechs flexibility says Macrogenics

Flexibility is vital for growing biopharmaceutical companies says Macrogenics, which used single-use tech to accelerate development of its Phase III manufacturing plant. Like many younger biotechnology companies, Macrogenics initially focused on product development rather than investing in production capacity. The Maryland firm was incorporated in 2000, however, it did not set up its first manufacturing facility until 2005. The plant was designed to manufacture candidates for Phase I/II trials and had limited capacity. Initially it could only carry out four…

With $30m in hand, Ori looks to advance closed cell therapy tech

Ori Biotech will use $30 million from a Series A financing round to finalize and test its closed and automated cell and gene therapy technology. In January, Ori Biotech came out of stealth mode through a $9.4 million seed round, introducing the cell and gene therapy space to its technology platform, which aims to significantly reduce the cost of production of such therapies. Nine months on and the firm has raised a further $30 million in a Series A financing…

Regeneron and Pfizer sued for ‘unauthorised’ reagent use

Allele Bio says Regeneron and Pfizer’s use of a labelling reagent during COVID-19-related vaccine and therapeutics development infringed on its IP. The San Diego biotech made the claim in lawsuits filed lawsuits against Regeneron and Pfizer this week. It said “both complaints address the infringement of Allele’s patented mNeonGreen reagent.†mNeonGreen is a fluorescent protein used in biological assays. Like Green Fluorescent protein, when mNeonGreen binds a specific molecule it gives off a fluorescent signal that can be used to…