Brook­ings pan­el of ex­perts lays out case for on­shoring man­u­fac­tur­ing

As the US and Eu­rope con­tin­ue to con­sid­er on­shoring phar­ma man­u­fac­tur­ing to shore up the in­ter­na­tion­al sup­ply chain, a pan­el of ex­perts, host­ed by the Brook­ings In­sti­tu­tion, ad­dressed how to shore up sup­plies and re­silien­cy as drug short­ages and oth­er sup­ply is­sues per­sist af­ter the pan­dem­ic’s ini­tial im­pact.

Speak­ing on lessons learned from the pan­dem­ic, Tom Bol­lyky, di­rec­tor of the Glob­al Health Pro­gram and Se­nior Fel­low for Glob­al Health, Eco­nom­ics and De­vel­op­ment at the Coun­cil on For­eign Re­la­tion, said that while there was gen­er­al suc­cess in mov­ing bil­lions of dos­es of the Covid-19 vac­cine once it be­came more wide­ly avail­able, there were still some dif­fi­cul­ties. More than two-thirds of coun­tries had ex­port re­stric­tions on es­sen­tial med­ical prod­ucts dur­ing the pan­dem­ic, Bol­lyky said.

Tom Bol­lyky

“The vast ma­jor­i­ty of them were longer than three months in du­ra­tion. Many of them over a year. Rel­a­tive­ly few of them were no­ti­fied to the WTO ac­cord­ing to WTO rules and in many cas­es that slowed the pro­duc­tion by dis­cour­ag­ing in­vest­ment in cross bor­der sup­ply chains,” he said.

Bol­lyky added that one of the ma­jor lessons of the pan­dem­ic is around ex­port re­stric­tions act­ing as a “hur­dle” to re­silien­cy and re­spond­ing to the pan­dem­ic, as the pro­duc­tion de­pends on the cross-bor­der move­ment of goods and in­vest­ment, and any bar­ri­ers to that flow may pre­vent a wider abil­i­ty to re­spond to a se­ri­ous pan­dem­ic.

How­ev­er, Bol­lyky not­ed that while there have been more con­ver­sa­tions, and in­vest­ments, about on­shoring the pro­duc­tion of es­sen­tial med­ical sup­plies, a “ro­bust” ef­fort to di­ver­si­fy glob­al sup­plies to cre­ate more re­silience has not been put in place.

Bol­lyky said:

This is huge­ly im­por­tant be­cause cross-bor­der move­ment is fun­da­men­tal there’s no fu­ture di­ver­si­fi­ca­tion of man­u­fac­tur­ing glob­al­ly with­out the cross-bor­der move­ment of goods. Even a coun­try like the US, even a sto­ried com­pa­ny like Pfiz­er, can’t pro­duce every­thing do­mes­ti­cal­ly. We have to re­ly on in­ter­na­tion­al sources for that. That’s on­ly go­ing to be more so for small phar­ma­ceu­ti­cal mar­kets, where they’re go­ing to have to re­ly on cross-bor­der pro­duc­tion. And this fail­ure to act in a way that we can cre­ate some pre­dictable rules of what’s go­ing to ap­ply in a cri­sis so that peo­ple can make those in­vest­ments and as­sure those goods in the fu­ture is go­ing to be a re­al prob­lem.

Tanya Al­corn

Tanya Al­corn, the SVP for ster­ile in­jecta­bles and biotech op­er­a­tions at Pfiz­er, said to pro­duce the vac­cine, Pfiz­er need­ed hun­dreds of ma­te­ri­als from over 80 sup­pli­ers in 20 dif­fer­ent coun­tries. The pos­si­ble on­shoring of ma­te­ri­als is not nec­es­sar­i­ly the on­ly an­swer, she said, and a more vi­able op­tion is more open trad­ing for bet­ter sup­ply chain re­silien­cy.

How­ev­er, Liz Ju­rin­ka, the se­nior pol­i­cy fel­low at the Yale To­bin Cen­ter and the op­er­at­ing di­rec­tor for health­care pol­i­cy at The Vis­tria Group, said that on­shoring could be help­ful in the con­text of the Covid pan­dem­ic and need­ing a multi­na­tion­al re­sponse. With sup­ply chains dis­rupt­ed by the pan­dem­ic, on­shoring could be help­ful to mit­i­gate that. The US is al­ready try­ing to jump in­to ac­tion, pledg­ing mil­lions of dol­lars to bring the man­u­fac­tur­ing of phar­ma­ceu­ti­cal in­gre­di­ents back to the US.

Yet this may come with chal­lenges as well. In boost­ing ac­tive phar­ma­ceu­ti­cal in­gre­di­ent (API) man­u­fac­tur­ing in the US, Al­corn point­ed out the pro­duc­tion of those ma­te­ri­als is very dif­fer­ent from more tra­di­tion­al drug pro­duc­tion. More en­vi­ron­men­tal man­age­ment and con­trol around the chem­i­cals in the APIs, plus en­sur­ing the prop­er health and safe­ty con­trols, adds to the costs of on­shoring API pro­duc­tion. She al­so added that on­shoring pro­duc­tion may not solve the en­tire prob­lem, as there are hun­dreds of ma­te­ri­als that go in­to API pro­duc­tion, so it’s not pos­si­ble to in­source all the start­ing ma­te­ri­als.

“We have many sup­pli­ers that we sourced raw ma­te­ri­als from and start­ing ma­te­ri­als from around the world. So we don’t put our eggs all in one bas­ket in one coun­try. We di­ver­si­fy across dif­fer­ent sup­pli­ers. We have re­dun­dan­cy and sup­pli­ers, and we’d rather cre­ate that trust­ful part­ner­ship with sup­pli­ers ver­sus try­ing to do every­thing our­selves. We can’t do every­thing our­selves. Just not it’s not fea­si­ble. It’s not prac­ti­cal,” Al­corn said.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Man­u­fac­tur­ing roundup: Catal­ent to pro­duce low-cost ver­sion of nalox­one; CSL opens R&D site

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.

Ribbon cutting ceremony for Thermo Fisher's new cell therapy manufacturing site in San Francisco

Ther­mo Fish­er moves on cam­pus with new cell man­u­fac­tur­ing site in San Fran­cis­co

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

As­pen looks to re­bound in pro­duc­tion and rev­enue af­ter Covid-19

Last year, South African-based vaccine manufacturer Aspen Pharmacare was facing reports that it had not received a single order for its manufactured Covid-19 shots and that manufacturing lines were sitting idle. But now the vaccine producer is looking to turn things around.

Aspen’s disclosure of its financial results in March unveiled that manufacturing revenue had decreased by 12% to R 603 million ($33.8 million), which Lorraine Hill, Aspen Group’s COO, said is attributable to lower Covid vaccine sales.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”