Q&A: Lon­za­'s Chris­t­ian Dowdeswell talks HPA­PIs and the Oas­mia deal

The mR­NA boom has been ben­e­fi­cial for CD­MOs, and Lon­za is no dif­fer­ent. It’s up­grad­ed three of its sites — two in Eu­rope and one in New Hamp­shire — since land­ing deals with Mod­er­na to pro­duce the biotech’s Covid-19 vac­cine, and is be­ing con­sid­ered one of the big­wigs that will be re­spon­si­ble for more than half of the world’s drug ca­pac­i­ty by 2025.

And last week, the Swiss drug­mak­er inched clos­er to that goal, when it an­nounced the com­ple­tion of a mas­sive up­grade at a Nan­sha, Chi­na man­u­fac­tur­ing site. The up­grade will ex­pand the com­pa­ny’s abil­i­ty to man­u­fac­ture high­ly po­tent ac­tive phar­ma­ceu­ti­cal in­gre­di­ents, and a deal has al­ready been signed with Oas­mia Phar­ma­ceu­ti­cals to make its ovar­i­an can­cer drug can­di­date. That will start lat­er this month.

Chris­t­ian Dowdeswell

Chris­t­ian Dowdeswell, Lon­za’s VP of com­mer­cial de­vel­op­ment for small mol­e­cules, talked to me about the in­tri­ca­cies of HPA­PIs and the im­por­tance of hav­ing a pres­ence in Chi­na. Here’s our con­ver­sa­tion.

What are some of the things that make the de­vel­op­ment and man­u­fac­tur­ing of HPA­PIs com­pli­cat­ed?

Due to its high tox­i­c­i­ty, high­ly po­tent APIs are harm­ful, which means that man­u­fac­tur­ing them re­quires an ex­treme­ly strict con­tain­ment and han­dling pro­ce­dure to en­sure the safe­ty of en­gi­neers and an ef­fi­cient tech­nol­o­gy trans­fer. This re­quires so­phis­ti­cat­ed fa­cil­i­ty de­signs, a pro­tec­tive strat­e­gy, as well as a well-trained work­force — which may be dif­fi­cult to es­tab­lish in-house. This is es­pe­cial­ly true for emerg­ing com­pa­nies who are more fo­cused on im­prov­ing the sci­ence of their com­pounds rather than man­u­fac­tur­ing it.

What are some of the ben­e­fits that comes with hav­ing this site lo­cat­ed in Chi­na?

For over 20 years, Lon­za has had a pres­ence in Chi­na and over time we have ex­pand­ed our ser­vices to meet the needs of our cus­tomer port­fo­lio of EMEA and US-head­quar­tered cus­tomers. Our re­cent­ly ex­pand­ed HPA­PI ca­pa­bil­i­ties in Nan­sha al­low us to con­tin­ue lever­ag­ing world-class, high-qual­i­ty and re­li­able lo­cal sup­pli­ers of raw ma­te­ri­als to help for speedy prob­lem-solv­ing and man­u­fac­tur­ing for our glob­al net­work. The bio­phar­ma ecosys­tem in Chi­na is rapid­ly de­vel­op­ing and our site helps us stay on the pulse on the mar­ket to sup­port our glob­al cus­tomers.

Can you tell me if oth­er deals with com­pa­nies have been signed? Are more on the way?

As of to­day, we have signed a part­ner­ship with Swedish com­pa­ny Oas­mia Phar­ma­ceu­ti­cal AB to de­liv­er cGMP-stan­dard drug sub­stance for their ovar­i­an can­cer drug can­di­date Cantrix­il. We look for­ward to sup­port­ing our US- and Eu­rope- head­quar­tered part­ners at our Nan­sha site to sup­port the suc­cess of their HPA­PIs.

Is there any­thing else im­por­tant about this deal that read­ers should know?

Lon­za is an es­tab­lished part­ner in de­vel­op­ing and man­u­fac­tur­ing HPA­PI, with more than 20 years’ ex­pe­ri­ence in safe­ly pro­gress­ing more than 30 prod­ucts from ear­ly-stage work to late-stage clin­i­cal or com­mer­cial­iza­tion.  The com­pa­ny has the ca­pa­bil­i­ties in place to safe­ly han­dle HPA­PI to ex­po­sure lev­els up to 100ng/m3 across all man­u­fac­tur­ing scales. With re­cent ac­qui­si­tions, Lon­za has al­so added par­ti­cle en­gi­neer­ing — mi­croniza­tion and spray dry­ing — for im­prov­ing bioavail­abil­i­ty and fi­nal drug prod­uct for­mu­la­tion un­der full con­tain­ment. The in­vest­ment in Chi­na there­fore com­ple­ments Lon­za’s range of HPA­PI ca­pa­bil­i­ties from de­vel­op­ment to com­mer­cial scale man­u­fac­tur­ing, in­clud­ing for­mu­la­tion and de­liv­ery, with our in­vest­ments in both tech­nol­o­gy and scale to en­sure that we en­able our cus­tomers to bring new med­i­cines to pa­tients faster.

George Scangos (L) and Marianne De Backer

Pi­o­neer­ing biotech icon George Scan­gos hands in his re­tire­ment pa­pers — and this time it’s for re­al

George Scangos, one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time.

The 74-year-old biotech legend spent close to three decades in a CEO post. The first was at Exelixis — which is still heavily focused on a drug Scangos advanced in the clinic. The second “retirement” was at Biogen, where he and his team were credited with a big turnaround with the now fading MS blockbuster Tecfidera. And the third comes at Vir, where he traded in his Big Biotech credentials for a marquee founder’s role back on the West Coast, hammering out a Covid-19 alliance with Hal Barron — then R&D chief at GSK — and breaking new ground on infectious diseases with some high-powered venture players.

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Jeanne Loring, director of the Center for Regenerative Medicine (Credit: Jamie Scott Lytle)

A stem cell pi­o­neer sent an ex­per­i­ment in­to space. Pa­tients are the next fron­tier

Last July, Jeanne Loring stood on a dirt road surrounded by Florida swampland and watched as a nearby SpaceX rocket blasted into the sky. The payload included a very personal belonging: cell clusters mimicking parts of her brain.

For more than two decades, Loring has been at the forefront of a stem cell field that always seems on the brink of becoming the next thing in medicine, but has been slow to lift off.

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FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

FDA takes next step in Tor­rent Phar­ma­ceu­ti­cal­s' trou­bled In­dia plant saga, is­sues OAI

The FDA has handed Torrent Pharmaceuticals an official action indicated (OAI) status for a previously inspected manufacturing facility in India.

Torrent Pharma sent a letter to the National Stock Exchange of India earlier this week with word that the manufacturer has received a “communication from the FDA determining the inspection classification as ‘Official Action Indicated’ (OAI)” for one of its sites. An OAI classification from the FDA comes after the agency has completed an inspection and determines if the facility complies with the applicable laws and regulations. Being given an OAI classification means that regulatory or administrative actions will be recommended to Torrent. However, the details on the recommended actions have not been given.

Man­u­fac­tur­ing roundup: AGC Bi­o­log­ics to man­u­fac­ture di­a­betes ther­a­py; Cam­brex caps ac­qui­si­tion of Snap­drag­on Chem­istry

The Washington-based CDMO AGC Biologics has been tapped to manufacture the type 1 diabetes treatment Tzield from Provention Bio.

AGC Biologics will produce Tzield at its Seattle protein biologics site. It was chosen after AGC helped to guide the product through process performance qualification (PPQ) manufacturing and validation batches, and, ultimately, FDA approval. Tzield is the only immunomodulatory treatment approved to delay the onset of Stage 3, type 1 diabetes in children and adults aged eight and older.

In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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Matthew Stober, newly-appointed Abzena CEO (Abzena)

Abzena lays off more than 60 em­ploy­ees in Cal­i­for­nia

Contract manufacturer Abzena has permanently laid off 66 employees at one of its San Diego sites, marking the latest in a string of layoffs spanning the biotech industry.

The layoffs took effect on Jan. 11 at the company’s 8810 Rehco Road site, according to a WARN notice filed with the Employment Development Department of California.

Abzena does have another location in the San Diego area, where the manufacturer invested $60 million and added 50,000 square feet in 2020. Endpoints News reached out to Abzena but has not received a response as of press time.

#JPM23: What's re­al­ly dri­ving the cost of health­care and drugs in 2023?

Executive Editor Drew Armstrong spoke with PhRMA CEO Steve Ubl, EmsanaRx CEO Greg Baker and ICER President Steve Pearson about how the debate over drug costs has changed (or not) in the last decade, the shifting payer landscape and why there seems to be so little movement on drug rebates. This transcript has been edited for brevity and clarity.

Drew Armstrong:

So first of all, thank you to everybody for being here and for our panel for being here. Incredibly excited to have this discussion on the cost of healthcare and drugs and what’s driving that. We’re here with Steve Ubl, the head of PhRMA. Thank you so much. Steve Pearson from ICER, and Greg Baker from EmsanaRx. I want to start this conversation with a little bit of a personal reminiscence. So about almost 10 years exactly. I was a reporter back in my previous job and I was covering drug pricing and Gilead had just launched their hepatitis C drug and I was having a conversation with another Steve over at Express Scripts and he made some comments essentially about how they intended to launch a price war over hepatitis C therapies.

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