Upstream & Downstream Processing

Podcast: Thermo Fisher on aseptic manufacturing in the time of COVID

In the latest episode of the BioProcess Insider Expression Platform, Thermo Fisher Scientific’s Vincenza Pironti discusses how vaccine and biologic makers can ensure a robust, global fill/finish supply both during the COVID pandemic and beyond. Vincenza Pironti – Global SME, Steriles, ThermoFisher Scientific – sat down (at a distance) with editor Dan Stanton to discuss aseptic manufacturing in the current climate as part of this year’s BIO-Europe Spring. The event took place last week, but if you missed it the…

COVID catalyst: MilliporeSigma expedites $30m French expansion

MilliporeSigma has accelerated plans to add a single-use assembly production unit at its site in Molsheim, France on the back of COVID-19 demand. The $30 million injection at the site, just west of Strasbourg, will add 18,300 square feet of cleanroom space to produce MilliporeSigma’s Mobius single-use assemblies for use in the production of both COVID-19 vaccines and other therapies. The expansion will generate more than 350 jobs. The facility will become the first European site to make the single-use…

Thermo Fisher rolls out 3,000 and 5,000 L single-use bioreactors

Strong demand for large-scale single-use systems has driven Thermo Fisher to launch bioreactors with capacities beyond the standard limits. Single-use bioreactors have become a staple in the bioprocess industry, both for clinical and commercial batches. Traditionally, these have been restricted in size due to pressure challenges from the increased weight of the liquid medium in larger volume bags with 2,000 L being the upper limit. Thus, if biomanufacturers require larger volumes, they generally would run several systems in unison or…

Thermo Fisher’s $600m injection: News? No, just business as usual

Thermo Fisher’s $600 million CAPEX has got the trade press salivating. But similar statements, expansions underway, and continued demand mean this is just another day in the pandemic-fueled bioprocess space. Yesterday, Thermo Fisher Scientific issued a press release to announce “more than $600 million in capital investments to expand its bioprocessing production capabilities through 2022.” The firm said: “These investments are expected to more than double the company’s current manufacturing capacity and support biopharma customers as they ramp up to…

Eurofins on how to get faster sterility results

Due to the 14-day incubation requirement for compendial sterility, this is often the last data available when testing BioPharmaceutical products for release or stability. So turnaround time pressure has always been an inherent part of sterility testing. This pressure has become more acute with the emergence of ATMPs, particularly autologous cell therapies which are often given to patients before traditional testing results can be obtained. Eurofins BioPharma Product Testing has responded to the demand for faster sterility results by streamlining…

Repligen eyes more M&A and expansions as demand continues to rocket

Repligen says it will both reinvest in its manufacturing network and look for M&A opportunities to feed the high demand for bioprocess consumables. For the full year 2020, bioprocessing tech firm Repligen Corporation reported sales of $366 million, up 36% year-on-year. The fourth quarter itself pulled in $108 million, representing a 56% increase on the same period 2019. As with fellow bioprocess vendors (Danaher, Sartorius, Thermo Fisher etc), COVID-19 played a major part in Repligen’s 2020 top line, with its…

Process intensification and PAT essential for achieving real-time release

Development of complex methods enabling real-time release of therapeutics requires creativity and collaboration, say experts from NIIMBL and SCIEX. Interest in real-time release (RTR) is driving the industry to think about process intensification in a coordinated manner. Process intensification offers the potential for increased efficiencies and thereby reduced cost and time for drug production. Workflows, capital and operating expenses, product quality, and waste production can all be positively impacted. There is consequently a push in the industry to develop and…

Affinity resins: Avitide gears up to support COVID-19 vaccine makers

Avitide says a specific SARS-CoV-2 virus spike protein affinity resin greatly helps the current COVID-19 efforts and could greatly accelerate the speed of response in future pandemics. Bioprocess service and consumable firms are looking to support the next wave of COVID-19 vaccines as they progress through the clinic. Last week, we reported that Repligen and Navigo launched an affinity resin specifically for the purification of COVID-19 vaccines. But they are not alone, and New Hampshire-based firm Avitide recently finalized its…

Repligen and Navigo target next-wave COVID vaccines with affinity resin

Repligen and Navigo have launched an affinity resin specifically for the purification of COVID-19 vaccines. Last year, bioprocess technology firm Repligen teamed with protein engineering firm Navigo Proteins GmbH to develop an affinity ligand specifically for COVID-19 vaccines. Like many COVID-19 vaccine and therapeutic efforts themselves, the collaboration plus speed of development have borne fruit with the firms launching the NGL COVID-19 Spike Protein Affinity Resin this week. While the handful of COVID-19 vaccines approved so far are not protein-based…

Thermo says COVID-19 vaccine and therapy work will generate $1bn in 2021

Thermo Fisher Scientific cited COVID-19 as a revenue driver in 2020 and predicted that pandemic-related work will make an even bigger contribution this year. Thermo’s revenues grew 26% in 2020 to $32.2 billion with COVID-19 testing and vaccine and therapy-related development activity generating $6.6 billion. The contribution from Thermo’s pharma and biotechnology business grew 25% in Q4 driven by increased demand for COVID-19 related bioproduction, pharma and bioscience services. Revenue from academic, government and industrial customers also increased as result…