Jean-Christophe Hyvert, Lonza president
April 8, 2022 01:18 PM EDT
Lonza’s automative manufacturing tech acquired by MilliporeSigma
Josh Sullivan
Associate Editor
When Lonza designed its MAST system, it was born out of troubles the company saw with Pfizer’s auto sampling process. Bioreactors got contaminated, systems got clogged, and therefore, samples became unreliable when they were sent to their destinations. Oregon-based Bend Solutions was brought on to work out a solution in 2012, and from there, the system was born.
Ten years later, it’s caught the eyes of the team at MilliporeSigma, Merck KGaA’s US and Canada division — and the company has now acquired the platform from Lonza.
“Today biopharmaceutical companies are under immense pressure to get products to patients faster. The acquisition of the MAST platform adds fully automated sampling to our bioprocessing portfolio,” said Merck KGaA’s Andrew Bulpin. “This technology, coupled with the software to analyze and manage data, allows us to offer unique and integrated solutions to help customers optimize their bioprocesses. The MAST platform moves us closer toward our vision of connected and continuous bioprocessing to increase speed and lower costs.”
The big draw to the MAST platform, which stands for Modular Automated Sampling Technology, is that it is able to produce more efficient and cost-effective drugs. MAST, which was designed to ensure sterility of samples, can grab them more frequently and produce real-time data in a matter of hours, as opposed to the weeks that come with manual sampling. One MAST unit can sample from up to 10 bioreactors and connect them to four analyzers. Sterile filtered purged gas, such as nitrogen, is pushed through the bioreactor in between batches, to ensure the purity of the batches. So far, MAST has been used to collect and deliver upstream cell culture, downstream purification and microbial fermentation.
MilliporeSigma believes that this can help move the system toward the digital manufacturing facility of the future. The platform is now part of the BioContinuum platform, which uses the Bio4C software suite to combine process control, analytics and plant-level automation for manufacturing.
“The Life Science business sector’s established experience implementing real-world data into its projects will enable it to further unlock the potential of the MAST® platform that Lonza has worked diligently to develop,” said Lonza’s president Jean-Christophe Hyvert. “With this divestment, we remain focused on our broad Bioscience offering, providing our customers with the tools to develop, manufacture and test therapeutics from basic research to the final product release.“
MilliporeSigma just acquired the CDMO Exelead in January, shortly after it landed a deal with Pfizer and BioNTech to make lipid nanoparticles for its Covid-19 vaccine. That $780 million deal added onto its buyout of mRNA manufacturer AmpTech early in 2021. That led to a massive reorganization of its CDMO and contract testing units, and spurred a 10-year investment in mRNA offerings.
Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)
April 7, 2022 07:12 AM EDTUpdated 07:47 AM
Surging ahead in the RSV race, Pfizer buys out a PhII player in $525M M&A pact
John Carroll
Editor & Founder
Right on the heels of back-to-back breakthrough therapy designations for its lead RSV vaccine, Pfizer is wagering up to $525 million on a biotech buyout that injects new RSV assets into its pipeline.
Pfizer is snapping up ReViral after inspecting mid-stage data for sisunatovir, an oral drug that blocks the fusion of RSV with host cells. And there’s more.
In their statement, Pfizer noted:
Sisunatovir significantly reduced viral load in a phase 2 RSV human challenge study in healthy adults and is currently in Phase 2 clinical development in infants. The development program for sisunatovir is expected to continue in both adult and pediatric populations. A second program is focused on the inhibition of RSV replication targeting the viral N protein. The lead candidate in this program is currently in Phase 1 clinical development.
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April 8, 2022 12:53 PM EDT
As part of scheme to triple revenue this year, AGC adds on to Spain site for HPAPIs
Josh Sullivan
Associate Editor
An AGC subsidiary in Europe will get a $100 million investment to add on a new building at the site, and add an expansion for the manufacturing of highly potent active pharmaceutical ingredients.
The move is a part of the medium-term management plan dubbed AGC plus-2023. The group is looking to grow its business from $361 million to $1.08 billion this year, and to $1.6 billion by the year 2025. These ambitions, while lofty, are aligned to keep the company on track with the growing demand of the global pharmaceutical CDMO market, which has grown more than 7% each year.
Sean Marett, BioNTech CBO and CCO
April 8, 2022 01:00 PM EDTUpdated 01:12 PM
Riding on coattails of Comirnaty success, BioNTech wins mRNA manufacturing contract with German government
Paul Schloesser
Associate Editor
German biotech and wildly successful Pfizer partner, BioNTech, has notched its next contract on home turf, courtesy of the German government.
The biotech, who partnered with Pfizer on the development of megablockbuster Covid-19 vaccine Comirnaty, said in a brief statement earlier today that it had been granted a pandemic preparedness contract from the federal government’s department of health — to manufacture and supply mRNA vaccines for emergency situations.
Larry Turka, Rubius Therapeutics CSO
April 8, 2022 01:00 PM EDTUpdated 01:19 PM
AACR22: Rubius touts new data for lead program, but will it prove effective enough for investors?
Looking to build on its first cut of human data from last year, Rubius Therapeutics is touting new Phase I data from its lead cancer program in both solid tumors and acute myeloid leukemia. But the results may prove disappointing after appearing to be less effective than the previous readout.
Rubius observed three partial responses among 27 evaluable patients with advanced solid tumors, the company said Friday at AACR, up from two PRs in 15 patients from a March 2021 update. Additionally, the biotech will be halting clinical development in AML for the “near-term,” CSO Larry Turka said, but left the door slightly open for a return in the future.
Michel Vounatsos, Biogen CEO (Biogen via YouTube)
April 8, 2022 12:58 PM EDTUpdated 01:12 PM
What did we learn from Biogen’s CMS slap down? Data rule
The CMS decision to formally restrict coverage on Aduhelm decisively hammered home the last nail on the Alzheimer’s drug’s commercial coffin. But the muted impact on Biogen’s beaten-down stock was ready evidence that investors had already walked away from the grave.
Shunned by independent experts and a whole swath of physicians who treat Alzheimer’s, longtime skeptic Brian Skorney at Baird now calls the Biogen drug Zombiehelm. And no manner of necromancy can revive it. The first approved drug for Alzheimer’s, what was always considered the Golden Ticket in drug R&D with a multibillion-dollar payout, is commercial waste.
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April 8, 2022 12:54 PM EDT
Viatris doubles down on Sesame Workshop collaboration, kicking in another $1M
As experts speculate that Covid-19 could soon shift to an endemic stage, Viatris is once again turning to everyone’s favorite muppets for its latest pandemic relief contribution.
The healthcare company — formed out of a merger between Mylan and Pfizer’s Upjohn unit — is donating another $1 million to Sesame Workshop to fund resources for parents and children navigating the next phase of the pandemic. The effort, dubbed “Caring For Each Other,” features videos starring Elmo and other “Sesame Street” characters discussing topics such as handling big changes.
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April 4, 2022 06:00 AM EDT
Avoiding Cell Therapy Manufacturing Gridlocks — a Do’s and Don’ts Guide
Endpoints Studio in partnership with Catalent
How can developers prepare for the most vulnerable aspects of the cell therapy process? What steps are needed to demonstrate product comparability, with a rapid scale-up to manufacturing? When does it make sense to partner with a custom manufacturer and how can they help throughout the regulatory process? Developers must orchestrate a complex set of steps to move preclinical molecules through the clinic and manufacture therapies at scale – all while meeting regulatory guidelines and protecting patient safety. In this report, we will offer a guide to these issues and more, with commentary from consultants and manufacturers who have successfully navigated these waters. If you are working to bring a cell therapy to clinic, this guide is for you.
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AstraZeneca solar panel field at its Macclesfield location in the UK.
April 8, 2022 11:54 AM EDT
AstraZeneca advances net-zero carbon goals, adding Honeywell deal and outsider oversight among new ESG efforts
Beth Snyder Bulik
Senior Editor
Just a few years ago, the pharma industry was labeled as a big-time carbon polluter in a study that showed greenhouse gas emissions that were 55% higher than the auto industry. The study and media reports that followed expressed some shock amid surprisingly scant attention paid to the industry by environmental watchers.
Since then, however, pharma companies have taken up the challenge — including efforts by many to drive to net-zero emission goals. AstraZeneca, along with Novartis and Merck, is leading the time race in the industry, setting company goals for 2025, followed by a larger group of pharmas aiming for 2030. ESG tracker SPGlobal notes J&J, Pfizer, GlaxoSmithKline, Sanofi and BioNTech among the latter group.
Kaleido CEO Dan Menichella (AP Photo/Andrew Harnik)
April 8, 2022 11:01 AM EDTUpdated 12:22 PM
UPDATED: Breaking: Flagship-backed microbiome company Kaleido Biosciences shuts down
Kyle LaHucik
Associate Editor
Three months after initiating layoffs, hitting pause on a planned COPD study and terminating an agreement with the COPD Foundation, Kaleido Biosciences is now shutting down.
On Friday, the biotech’s board voted to “immediately wind-down and cease all of the Company’s ongoing operations,” according to an SEC filing. CEO Daniel Menichella, CFO William Duke, and CSO Johan van Hylckama Vlieg were let go immediately. Kaleido’s stock price $KLDO fell nearly 76% to about 36 cents apiece.
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