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Lonza to Buy Genentech’s Vacaville, CA Biologics Manufacturing Site for $1.2B

With a total bioreactor capacity of about 330,000 liters, in reactor sizes of 12,000 and 25,000, the Vacaville plant is among the largest biologics manufacturing…

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Lonza has agreed to acquire Genentech’s large-scale biologics manufacturing site in Vacaville, CA, from Genentech’s parent Roche for $1.2 billion, the companies said, in a deal designed to significantly increase the buyer’s capacity for manufacturing biologics at commercial scale.

With a total bioreactor capacity of about 330,000 liters, in reactor sizes of 12,000 and 25,000, the Vacaville plant is among the largest biologics manufacturing sites in the world by volume. That capacity will grow in coming years, Lonza said, as it plans to invest approximately CHF 500 million ($556.6 million) to upgrade the Vacaville plant, a capital project intended to enhance its ability to satisfy demand for next-generation mammalian biologics therapies.

During the upgrade, Lonza will manufacture existing products for Roche at a committed volume of 30% of capacity in 2025. Those volumes will ramp down over the medium term, Lonza said.

Roche inherited the Vacaville site in 2009 when it completed its $46.8 billion acquisition of Genentech, which built the facility and put it into operation in 2000.

Since then, Lonza said in a presentation to analysts, nine commercial product families have been manufactured at Vacaville, including the COVID-19 antibody “cocktail” or combination treatment of casirivimab and imdevimab that Roche developed with Regeneron Pharmaceuticals during the COVID-19 pandemic. The cocktail had been marketed as REGEN-COV in the U.S. and Ronapreve outside the U.S.—but is no longer FDA-authorized following the growth of cases stemming from the Omicron variant of COVID-19.

“We decided to divest our Vacaville site as part of our long-term network strategy and
optimisation plan, to deliver a more diversified portfolio including new drug modalities,”
Susanne Hundsbaek-Pedersen, Global Head of Pharma Technical Operations, stated. “Having gone through a competitive diligence process with multiple potential strategic partners for the facility, we believe that Lonza is the ideal owner for the Vacaville site to continue producing innovative medicines for patients in need. We are particularly pleased that the employees at the site will be offered employment by Lonza.”

Market share vs. pharmas

The presentation by Lonza’s top executives offered another rationale for the deal: Lonza expects CDMOs to command more than half the expected market share of installed mammalian drug substance manufacturing capacity by 2028—52% vs. 48% for pharmaceutical companies, compared with 39% for CDMOs and 61% for pharmas last year.

CDMO share of installed mammalian capacity has grown from 25% in 2013, and 29% in 2018, while pharma capacity has shrunk from 75% in 2013 and 71% five years later, according to data cited by Lonza—derived from an internal company analysis as well as data from IQVIA, EvaluatePharma, Citeline, and publicly announced capacity expansions last year.

Lonza said it would offer employment to the plant’s approximately 750 Genentech employees.

“Looking ahead, we are excited about the continued growth and innovation that Lonza will bring to Vacaville,” Vacaville Mayor John Carli stated in a Facebook post. “While we bid farewell to Genentech, we are grateful for their significant contributions over the past 25 years. The medicines produced at the Vacaville facility have undoubtedly impacted countless lives worldwide, and we are proud to have been a part of that journey.”

Lonza said the acquisition would help it better meet demand for mammalian contract manufacturing from customers with existing commercial products, as well as those with molecules in process of being developed into commercial products.

The Vacaville plant will also create for Lonza a significant U.S. West Coast commercial manufacturing presence, complementing the company’s existing biologics site on the East Coast in Portsmouth, NH, as well as its network of international facilities across Europe and Asia.

“The Vacaville site is a highly valuable strategic acquisition that will make capacity immediately available for our customers and unlock future growth for our Biologics division,” Jean-Christophe Hyvert, president, biologics, Lonza, said in a statement. “It will support us in providing a commercialization path to existing customers and incremental large-scale commercial capacity to our partners.”

Products now manufactured at the site by Roche will be supplied by Lonza, with committed volumes over the medium term, phasing out over time as the site transitions to serve alternative customers.

As a result of the Vacaville deal, Lonza has updated its Mid-Term Guidance 2024–2028 by raising its projected sales growth range from an 11–13% compound annual growth rate (CAGR) to between 12% and 15% CAGR, both at constant exchange rates (CER). Lonza finished 2023 with CHF 655 million ($729 million) in profit on CHF 6.717 billion ($7.479 billion) in sales, up 7.9% (10.9% at CER) from CHF 6.223 billion ($6.929 billion).

Profits fell 46% from CHF 1.218 billion ($1.356 billion) in 2022, in large part due to about CHF 500 million ($556.6 million) in sales and termination cost impacts stemming from Moderna reducing production of mRNA drug substance for its COVID-19 vaccine at Visp, Switzerland, announced in September.

The deal is expected to close in the second half of this year, subject to customary closing conditions. Upon closing, Lonza will integrate the Vacaville site into its Biologics division, joining a network of existing mammalian manufacturing sites in Portsmouth and Visp, as well as Slough, U.K., Singapore, and Porriño, Spain.

“Next chapter”

“We have deep and long-standing industrial expertise in delivering commercial scale manufacturing services for our customers’ therapies. In combining this with the strong legacy of the Vacaville facility, its highly skilled colleague community and its proven track record on quality, we are excited to take our leading large-scale mammalian offering to its next chapter of growth,” Hyvert added.

The acquisition comes at a time of tumult for contract manufacturing and development organizations (CDMOs).

Last month, Catalent found a buyer when Novo Holdings, the asset manager of the foundation that controls Novo Nordisk, agreed to acquire the company for $16.5 billion. Novo Holdings stands to recoup two-thirds of that expense by selling three of Catalent’s fill-finish sites to Novo Nordisk for $11 billion upfront so it can meet booming demand for its blockbuster obesity drugs Wegovy® and diabetes drug  Ozempic®.

And in Congress, the U.S. House of Representatives’ Select Committee on the Strategic Competition between the United States and the Chinese Communist Party Chairman Mike Gallagher (R-WI) and Ranking Member Raja Krishnamoorthi (D-IL) have joined to introduce the BIOSECURE Act (H.R. 7085).

The measure would forbid the awarding of federal contracts—including procurement of drugs for Medicare and Medicaid—from being awarded to “foreign adversary biotech companies of U.S. national security concern.” Among Chinese companies cited by name in the bill are two CDMOs, WuXi Apptec and WuXi Biologics.

WuXi AppTec has denied posing a threat to U.S. security, while WuXi Biologics has issued a statement taking issue with the bill’s description of the background of CEO Chris Chen.

The post Lonza to Buy Genentech’s Vacaville, CA Biologics Manufacturing Site for $1.2B appeared first on GEN - Genetic Engineering and Biotechnology News.

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International

You can now enter this country without a passport

Singapore has been on a larger push to speed up the flow of tourists with digital immigration clearance.

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In the fall of 2023, the city-state of Singapore announced that it was working on end-to-end biometrics that would allow travelers passing through its Changi Airport to check into flights, drop off bags and even leave and exit the country without a passport.

The latter is the most technologically advanced step of them all because not all countries issue passports with the same biometrics while immigration laws leave fewer room for mistakes about who enters the country.

Related: A country just went visa-free for visitors with any passport

That said, Singapore is one step closer to instituting passport-free travel by testing it at its land border with Malaysia. The two countries have two border checkpoints, Woodlands and Tuas, and as of March 20 those entering in Singapore by car are able to show a QR code that they generate through the government’s MyICA app instead of the passport.

A photograph captures Singapore's Tuas land border with Malaysia.

Here is who is now able to enter Singapore passport-free

The latter will be available to citizens of Singapore, permanent residents and tourists who have already entered the country once with their current passport. The government app pulls data from one's passport and shows the border officer the conditions of one's entry clearance already recorded in the system.

More Travel:

While not truly passport-free since tourists still need to link a valid passport to an online system, the move is the first step in Singapore's larger push to get rid of physical passports.

"The QR code initiative allows travellers to enjoy a faster and more convenient experience, with estimated time savings of around 20 seconds for cars with four travellers, to approximately one minute for cars with 10 travellers," Singapore's Immigration and Checkpoints Authority wrote in a press release announcing the new feature. "Overall waiting time can be reduced by more than 30% if most car travellers use QR code for clearance."

More countries are looking at passport-free travel but it will take years to implement

The land crossings between Singapore and Malaysia can get very busy — government numbers show that a new post-pandemic record of 495,000 people crossed Woodlands and Tuas on the weekend of March 8 (the day before Singapore's holiday weekend.)

Even once Singapore implements fully digital clearance at all of its crossings, the change will in no way affect immigration rules since it's only a way of transferring the status afforded by one's nationality into a digital system (those who need a visa to enter Singapore will still need to apply for one at a consulate before the trip.) More countries are in the process of moving toward similar systems but due to the varying availability of necessary technology and the types of passports issued by different countries, the prospect of agent-free crossings is still many years away.

In the U.S., Chicago's O'Hare International Airport was chosen to take part in a pilot program in which low-risk travelers with TSA PreCheck can check into their flight and pass security on domestic flights without showing ID. The UK has also been testing similar digital crossings for British and EU citizens but no similar push for international travelers is currently being planned in the U.S.

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Government

The Virality Project’s Censorship Agenda

The Virality Project’s Censorship Agenda

Authored by Andrew Lowenthal via the Brownstone Institute,

In November 2023 Alex Gutentag and…

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The Virality Project’s Censorship Agenda

Authored by Andrew Lowenthal via the Brownstone Institute,

In November 2023 Alex Gutentag and I reported on the Virality Project’s internal content-flagging system, as released by the US House Committee on the Weaponization of the Federal Government.

Initiated by the Department of Homeland Security (DHS) and the Cybersecurity and Infrastructure Security Agency (CISA) and led by the Stanford Internet Observatory (SIO), the Virality Project sought to censor those who questioned government Covid-19 policies. The Virality Project primarily focused on so-called “anti-vaccine” “misinformation;” however, my Twitter Files investigations with Matt Taibbi revealed this included “true stories of vaccine side effects.”

A further review of the content flagged by the Virality Project demonstrates how they pushed social media platforms to censor such “true stories.” This was often done incompetently and without even a cursory investigation of the original sources. In one instance, the Virality Project reporters told platforms that reports of a child injured in a vaccine trial were “false” due to the timing; citing the dates of a Moderna trial when in fact the child had been in a Pfizer trial.

Trigger-happy researchers-turned-activists at the Virality Project went further, alerting their Big Tech partners (including Facebook, Twitter, Instagram, and TikTok) of protests, jokes, and general dissent.

Led by former CIA fellow Renee DiResta, the Virality Project functioned as an intermediary for government censorship. Ties between the US government and the academic research center were extremely close. DHS had “fellows” embedded at the Stanford Internet Observatory, while SIO had interns embedded at CISA, and former DHS staff contributed to the Virality Project’s final report.

The Virality Project also had contact with the White House and the Office of the Surgeon General, described the CDC as a “partner” in its design documents, and the California Department of Public Health had a login to access the Jira content flagging system, as did CISA personnel.

Kris Krebs and Alex Stamos – former directors of CISA and SIO, respectively – became business partners soon after leaving their positions.

Norwood v. Harrison established that the government “may not induce, encourage or promote private persons to accomplish what it is constitutionally forbidden to accomplish.” Stamos knew this too and put it simply; the government “lacked the legal authorisation” and so they built a consortium to “fill the gap of the things the government could not do themselves.”

Judicial precedents regarding “joint participation” and “pervasive entwinement” between public and private entities make clear that the government cannot outsource to third parties like the Virality Project actions that would be illegal for the government itself to do.

The Virality Project had several unnamed partners that appear in the content-flagging system, including billion-dollar military contractor MITRE and a communications consultancy linked to the Democratic Party, Hattaway. Founder Doug Hattaway was an “advisor and spokesperson for Secretary of State Hillary Clinton, Vice President Al Gore, and Senate Majority Leader Tom Daschle, and provided strategic counsel to the Obama White House and the Democratic leadership of the US House and Senate.” Like the Virality Project, Hattaway worked with the Rockefeller Foundation during the pandemic on issues of disinformation.

The Virality Project does not declare any relationship with MITRE or Hattaway despite providing them access to their Jira system.

The Virality Project was partly funded by the Omidyar Network, which provided $400,000 to VP partner and Pentagon consultant Graphika. Much of the Virality Project’s funding however is unknown and is also not declared on their website.

This and much more have led five plaintiffs, including Harvard and Stanford professors, to accuse the US government of violations of the First Amendment with the Virality Project as one of the key proxies. On March 18, their case will be heard by the US Supreme Court.

The Virality Project and Murthy v. Missouri

The Murthy vs Missouri plaintiffs allege that, “CISA launched a colossal mass surveillance and mass-censorship project calling itself the “Election Integrity Partnership” (and later, the “Virality Project”). The Election Integrity Project (EIP) “monitored 859 million posts on Twitter alone.” 

The Virality Project used the same Jira system as EIP for flagging content and included the same core public partners: SIO, the University of Washington Center for an Informed Public, the Atlantic Council’s Digital Forensic Research Lab, and Graphika, with the addition of NYU and the congressionally chartered National Conference on Citizenship.

The Virality Project had extensive contact not only with CISA but also with the White House and the Surgeon General. White House representatives sent direct censorship requests to Twitter including, “Hey folks – Wanted to flag the below tweet and am wondering if we can get moving on the process for having it removed ASAP.” And the more threatening:

 “Are you guys fucking serious? I want an answer on what happened here and I want it today.”

Flaherty also conveyed that his communications came with the backing of the very top echelons of the administration: “This is a concern that is shared at the highest (and I mean highest) levels of the WH.”

The Virality Project hosted a launch with the US Surgeon General Vivek Murthy as part of the Surgeon General’s campaign against “misinformation.” In the presentation, Renee DiResta also introduced Matt Masterson, former senior adviser at DHS, and now a “non-resident policy fellow” at SIO.

Murthy ends the presentation by telling Renee, “I just want to say thank you to you, for everything you have done, for being such a great partner.”

At that same time the White House, OSG, and others were on the warpath, claiming social media platforms were “killing people” for allowing so-called “misinformation” to circulate.

With access to the White House, the Surgeon General, CDC, DHS, and CISA, along with top-level relationships with almost every major Western social media platform, the Virality Project was a key, if not the key, coordinating node for Covid-related censorship on the Internet. 

The Content-Flagging System

When the Virality Project said it considered, “true stories of vaccine side effects” to be “misinformation,” it wasn’t joking, and it flagged content to its Big Tech partners accordingly. 

Perhaps the most egregious was that of Maddie de Garay. Maddie and her siblings were enrolled in the Pfizer vaccine trial at the Cincinnati Children’s Hospital. She was later unblinded and confirmed as being in the vaccine and not the placebo group. 

Within 24 hours of her second shot in January 2021, Maddie developed a host of symptoms, including “severe abdominal pain, painful electric shocks on her spine and neck, swollen extremities, ice cold hands, and feet, chest pain, tachycardia, pins and needles in her feet that eventually led to the loss of feeling from her waist down.” To this day Maddie continues to suffer from a lack of feeling in her lower legs, difficulty eating, poor eyesight, and fatigue among other persisting symptoms.

Virality Project staff logged a Jira ticket titled “Maddie’s Story: False claim that 12-year-old was hospitalized due to vaccine trial” and provided extensive documentation of offending “engagement” on social media, including the micro-policing of content citing Maddie’s story with just two likes and two shares.

Much doubt has been cast on the veracity of Maddie’s injuries. Maddie’s mother, Stephanie de Garay, provided me with several doctor’s letters that confirm the link, including that of the emergency room doctor who discharged her on her initial visit. Their diagnosis was “Adverse effect of the vaccine.” Stephanie de Garay also testified under oath in front of the US Congress in November of 2023 regarding her daughter’s experience.

Most egregiously, the idea that the story was “false”rested on the claim that Maddie was in a Moderna trial. But she was in a Pfizer trial, as stated in the posts the Virality Project collected and linked to in the very same ticket.

“Dear Platform Partners,” the reporter writes as they bring the posts to the attention of Google, Facebook, Twitter, TikTok, Medium, Pinterest, and the aforementioned Hattaway Communications:

…very likely false due to issues in timing. The Moderna trial in children [began on March 16], when the participants received their first doses. However, the video claims that Maddie has an MRI scheduled for 03/16, and that these symptoms have been occurring for 1.5 months. Thus, Maddie would have had to have received the second dose of the vaccine during/before February, which is at least a month before the Moderna trials began.

“Ack – thanks for raising!” replies a platform representative. 

Not only are our self-appointed censorship overlords micro-managers, they are often incompetent. 

The posts were flagged “General: Anti-Vaccination” despite the de Garays volunteering their three children for the vaccine trial.

Some content flagged in the report remained up, and others were taken down. A video of Stephanie de Garay’s testimony was removed from Twitter. Whether or not this was specifically taken down due to the Virality Project report cannot be ascertained, but their intent was clear.

In another instance, the Virality Project wanted people circulating a mainstream media report censored:

“Platforms, this unconfirmed story of a healthy youth athlete who was hospitalized after being vaccinated continues to be used by anti-vaccine activists to spread misinformation about vaccines.”

“ack, thanks” responded a platform representative. 

Even a report by an ABC news affiliate, one of the biggest media conglomerates in the United States, fell into the category of “General: anti-vaccination” and “Misleading Headline.”

The main link provided, to a YouTube video, was removed. 

The Jira system was set up to track the actions the Big Tech partners took, as illustrated below:

The content was flagged to get platforms to take action.

“Hello Google team – sending this over as our analysts noticed that a google ad on a politico article this morning was peddling the antivax claims from the medical racism video you were monitoring. Is this against your policies?”

“Thanks for flagging – ack and sending for review.”

“Thanks for the heads up – we’re on it”

“Thanks for sharing! Our team is now tracking this.”

And follow-ups from the Virality Project team:

“Were the ads supposed to have been taken down? Just flagging for you, I just checked now and I’m still seeing another medical racism ad.”

Platforms were apologetic when they didn’t get to Virality Project’s flags quickly enough:

“With apologies for the delayed response (was in meetings) – we took action earlier in the afternoon, thanks again for the flags.”

This of course built on the Election Integrity Partnership’s more flagrant “recommendations,” which included

“We recommend that you all flag as false, or remove the posts below.”

“Hi Facebook, Reddit, and Twitter…we recommend it be removed from your platforms.”

And many more.

The Virality Project was a strategic intermediary between the US government and major social media platforms. As Murthy v. Missouri shows, in many cases the government dispensed even with their chosen intermediary and directly demanded censorship.

With their vast resources, why did Google, Facebook, and Twitter even need an external consortium to flag “misinformation?” The answer of course is they didn’t, the government did. Much like SIO Director Alex Stamos so helpfully reminded us, First Amendment jurisprudence states that the government “may not induce, encourage or promote private persons to accomplish what it is constitutionally forbidden to accomplish.”

The First Amendment protects false speech. There is a cost to false claims, but the cost of censoring true claims is much higher. The alternative is a society where the truth is suppressed and powerful actors become even more unaccountable. The government cannot be made an arbiter of what is true.

In this inverted world, the role of academia and civil society isn’t to harness the internet to better pick up safety signals related to corporate products, it is to shield corporations from public scrutiny. In times gone by such ethical violations would see institutions shut down, but the Stanford Internet Observatory and their consortium partners continue with hardly a dent.

Dr. Aaron Kheriaty is a Murthy v. Missouri plaintiff and was the Director of the Medical Ethics Program at the University of California Irvine before he was fired for challenging the university’s vaccine mandate. Asked for his reaction to this censorship he responded: 

While causation in medicine is sometimes difficult to establish, and different evaluating physicians may reach divergent conclusions about a particular case, the Virality Project’s censors (who lacked even basic medical expertise) arrogated to themselves the authority to make veracity judgments about particular medical cases–even overriding the judgments of evaluating physicians. Such censorship is completely antithetical to medical and scientific progress, which relies upon free inquiry and open, public debate.

Much of what the Virality Project flagged was plausible; however, their internet hall monitors, who likely lacked even first aid certificates, deemed themselves arbiters of the truth, and coupled their arrogance with a complimentary laziness and incompetence.

The veracity of the content was of course always irrelevant to the Virality Project, given they considered “true stories” to be “misinformation.”

All told the DHS, CISA, the White House, the Surgeon General, a DNC-aligned communications agency, military contractors, academics, NGOs, and more combined to suppress the stories of real people, including children, who were plausibly injured by the vaccine. They sought to hide it not because it might be false, but precisely because it might be true.

Republished from the author’s Substack

Andrew Lowenthal is a Brownstone Institute fellow and co-founder and former executive director of EngageMedia, an Asia-Pacific digital rights, open and secure technology, and documentary non-profit, and a former fellow of Harvard’s Berkman Klein Center for Internet and Society and MIT’s Open Documentary Lab.

Tyler Durden Thu, 03/21/2024 - 13:05

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International

This country became first in the world to let in tourists passport-free

Singapore has been on a larger push to speed up the flow of tourists with digital immigration clearance.

Published

on

In the fall of 2023, the city-state of Singapore announced that it was working on end-to-end biometrics that would allow travelers passing through its Changi Airport to check into flights, drop off bags and even leave and exit the country without a passport.

The latter is the most technologically advanced step of them all because not all countries issue passports with the same biometrics while immigration laws leave fewer room for mistakes about who enters the country.

Related: A country just went visa-free for visitors with any passport

That said, Singapore is one step closer to instituting passport-free travel by testing it at its land border with Malaysia. The two countries have two border checkpoints, Woodlands and Tuas, and as of March 20 those entering in Singapore by car are able to show a QR code that they generate through the government’s MyICA app instead of the passport.

A photograph captures Singapore's Tuas land border with Malaysia.

Here is who is now able to enter Singapore passport-free

The latter will be available to citizens of Singapore, permanent residents and tourists who have already entered the country once with their current passport. The government app pulls data from one's passport and shows the border officer the conditions of one's entry clearance already recorded in the system.

More Travel:

While not truly passport-free since tourists still need to link a valid passport to an online system, the move is the first step in Singapore's larger push to get rid of physical passports.

"The QR code initiative allows travellers to enjoy a faster and more convenient experience, with estimated time savings of around 20 seconds for cars with four travellers, to approximately one minute for cars with 10 travellers," Singapore's Immigration and Checkpoints Authority wrote in a press release announcing the new feature. "Overall waiting time can be reduced by more than 30% if most car travellers use QR code for clearance."

More countries are looking at passport-free travel but it will take years to implement

The land crossings between Singapore and Malaysia can get very busy — government numbers show that a new post-pandemic record of 495,000 people crossed Woodlands and Tuas on the weekend of March 8 (the day before Singapore's holiday weekend.)

Even once Singapore implements fully digital clearance at all of its crossings, the change will in no way affect immigration rules since it's only a way of transferring the status afforded by one's nationality into a digital system (those who need a visa to enter Singapore will still need to apply for one at a consulate before the trip.) More countries are in the process of moving toward similar systems but due to the varying availability of necessary technology and the types of passports issued by different countries, the prospect of agent-free crossings is still many years away.

In the U.S., Chicago's O'Hare International Airport was chosen to take part in a pilot program in which low-risk travelers with TSA PreCheck can check into their flight and pass security on domestic flights without showing ID. The UK has also been testing similar digital crossings for British and EU citizens but no similar push for international travelers is currently being planned in the U.S.

Read More

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