TCG GreenChem facilities in Princeton South, New Jersey (file photo)

In­di­a's TCG launch­es new CD­MO arm state­side to meet the call for 'Amer­i­can-made' pan­dem­ic drugs

Thanks to 57,000 square feet of re­al es­tate in New Jer­sey and Vir­ginia, a new CD­MO arm of In­dia’s TCG Life­sciences now has a US foot­print and will use it to fo­cus on ef­fi­cient and cheap pro­duc­tion of Covid-19 re­lat­ed med­i­cines and oth­er an­tivi­ral drugs.

Called TCG GreenChem, the new man­u­fac­tur­ing sub­sidiary will op­er­ate out of 3,000 square feet of lab space in Vir­ginia Com­mon­wealth Uni­ver­si­ty’s Biotech­nol­o­gy Re­search Park and 54,000 square feet of lab and of­fice space in Prince­ton’s South Cor­po­rate Cen­ter.

The com­pa­ny will of­fer CMC ser­vices for de­vel­op­ment and clin­i­cal tri­al sup­ply, ac­cord­ing to a press re­lease. The new sub­sidiary will al­so work to “ac­cel­er­ate the tran­si­tion of drug can­di­dates” through the pipeline by uti­liz­ing what it calls con­tin­u­ous flow tech­nol­o­gy.

Swa­pan Bhat­tacharya

While Covid-19 will like­ly be the main fo­cus for GreenChem as the pan­dem­ic con­tin­ues to evolve, the com­pa­ny will al­so use its ca­pac­i­ty to de­vel­op API for oth­er drugs. In the re­lease, the com­pa­ny tout­ed its abil­i­ties to uti­lize “deep ex­per­tise in ar­eas of au­to­mat­ed catal­y­sis/re­ac­tion screen­ing, re­ac­tion op­ti­miza­tion, and con­tin­u­ous chem­istry to sup­port the needs of the big phar­ma and biotech in­dus­try.”

GreenChem will al­so work to de­vel­op nov­el process­es for med­i­cines re­lat­ed to the virus, and said it is al­ready un­der con­tract with re­search foun­da­tions and hos­pi­tals, the US gov­ern­ment and un­spec­i­fied biotech com­pa­nies.

In a state­ment, Swa­pan Bhat­tacharya, TCG Life­sciences’ man­ag­ing di­rec­tor, praised the com­pa­ny’s man­age­ment team as vi­tal­ly im­por­tant to the new com­pa­ny’s goals.

“The pri­or­i­ty of our cus­tomers to­day is to find ways to lever­age their ex­ter­nal part­ners to fill up a large part of their prod­uct de­vel­op­ment needs,” Bhat­tacharya said. “In or­der to be­come their pre­ferred part­ners, we need to pro­vide high qual­i­ty, ef­fi­cient and low-cost ser­vices which are on­ly pos­si­ble if we de­ploy high-end tal­ents and skills that can dri­ve in­no­va­tion.”

Both TCG Life­sciences and TCG GreenChem are fund­ed by The Chat­ter­jee Group, a pri­vate eq­ui­ty firm that has its hooks in biotech, biotech re­al es­tate, petro­chem­i­cal, IT and aca­d­e­m­ic re­search out­lets.

The In­di­an CD­MO is a late en­try to the race for a Covid-19 man­u­fac­tur­ing re­sponse state­side. With the fi­nan­cial back­ing of the Trump ad­min­is­tra­tion, a group of up­start CD­MOs tar­get­ing Covid-19 re­lat­ed gener­ics has earned big con­tracts from the gov­ern­ment to ped­dle their wares.

One point of dif­fer­en­ti­a­tion is GreenChem’s In­di­an ori­gins. In­dia, one of the largest pro­duc­ers of API and fin­ished gener­ics shipped to the US, has be­come a tar­get for US law­mak­ers look­ing to ease the coun­try’s de­pen­dence on for­eign drugs amid the pan­dem­ic. With Trump out the door, the Biden ad­min­is­tra­tion hasn’t shown the same ex­plic­it­ly na­tivist dri­ve for “on­shoring” drug sup­ply chains — an ini­tia­tive deeply un­pop­u­lar in phar­ma.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Tom Barnes (Orna)

The mR­NA era is here. MPM be­lieves the fu­ture be­longs to oR­NA — and Big Phar­ma wants a seat at the ta­ble

If the ultra-fast clinical development of Covid-19 vaccines opened the world’s eyes to the promises of messenger RNA, the subsequent delays in supply offered a crash course on the ultra-complex process of producing them. Even before the formulation and fill-finish steps, mRNA is the precious end product from an arduous journey involving enzyme-aided transcription, modification and purification.

For Bristol Myers Squibb, Novartis Institutes for Biomedical Research, Gilead’s Kite and Astellas, it’s time to rethink the way therapeutic RNA is engineered.

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Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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Avid Bioser­vices, with re­cent IPO and Covid-19 part­ner­ship in hand, launch­es 2nd phase of fa­cil­i­ty ex­pan­sion

California’s Avid Bioservices now has two simultaneous expansion projects underway as the CDMO’s projections for customer demand sparked the launch this week of the second phase of building out its Myford facility.

Avid expects construction on the second phase, which will be known as its Myford South facility to take 18 to 24 months to complete at a cost of roughly $45 million to $55 million, it said in a press release.

Joe Biden (Credit: Doug Mills/The New York Times/Bloomberg via Getty Images)

Biden wants a re­view of the API sup­ply chain. Will that par­lay in­to an ef­fort to 'on­shore' drug man­u­fac­tur­ing?

When former President Donald J. Trump was voted out of office Nov. 2, his gung-ho effort to “onshore” drug manufacturing was left mostly up in the air. Joe Biden has been mostly mum on whether he would continue that effort, but a new executive order could provide a clue — at least in a few months.

In an order signed Wednesday, Biden demanded a 100-day governmental review of key supply chains, including for active pharmaceutical ingredients (API) used in American drugs.

S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Dutch biotech In­travacc seeks to bol­ster Nether­lands vac­cine man­u­fac­tur­ing abil­i­ties with new plants

The pandemic has given a huge edge to any country that can produce vaccine in its borders. Now one vaccine biotech is looking to make sure their country has that edge for any future pandemic.

Arguing Covid-19 exposed the Netherlands’ “vulnerability,” Dutch vaccines company Intravacc recently announced that its new “modern pilot production plant” will soon be functional and that it’s spearheading a conglomerate designing a multipurpose vaccine production plant.