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.

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.