At busy Visp site, Lon­za will up mi­cro­bial ser­vices by 50%

In an ef­fort to up its de­vel­op­ment of mi­cro­bial-de­rived pro­teins, Swiss CD­MO Lon­za will in­vest in its man­u­fac­tur­ing ca­pac­i­ties in its home coun­try.

The ex­ten­sion will be good to go by the end of this year, the com­pa­ny said. The ex­pand­ed de­vel­op­ment will strength­en the up­stream, down­stream and process an­a­lyt­ics sup­port for new projects. The mi­cro­bial foot­print at its Visp site will be con­sol­i­dat­ed, and new high-through­put equip­ment and au­toma­tion process­es will be added to in­crease ef­fi­cien­cy and project de­liv­ery. That will in­clude three liq­uid han­dling work­sta­tions, and the up­grades will help im­prove da­ta gen­er­a­tion.

Vice Pres­i­dent Shi­va Kha­laf­pour said in a press re­lease:

The mi­cro­bial-de­rived pipeline is grow­ing at a healthy rate dri­ven by an in­crease in al­ter­na­tives to an­ti­bod­ies such as nanobod­ies, de­signed ankyrin re­peat pro­teins (DARPins), sin­gle-chain an­ti­bod­ies, etc. For some of these mol­e­cules, mi­cro­bial sys­tems show bet­ter and more ef­fi­cient pro­duc­tiv­i­ties, which is in­creas­ing the trend to­ward out­sourc­ing as cus­tomers need to re­ly on key mi­cro­bial ex­per­tise. Ex­pand­ing our de­vel­op­ment lab­o­ra­to­ries will en­able us to sup­port new cus­tomers with the de­vel­op­ment and man­u­fac­ture of these mol­e­cules and oth­er re­com­bi­nant pro­teins for both clin­i­cal and com­mer­cial projects.

The ex­pan­sion will al­so fea­ture a new pi­lot suite with a 50L fer­menter that can gen­er­ate non-GMP prod­uct for for­mu­la­tion and tox­i­col­o­gy stud­ies, as well as new man­u­fac­tur­ing ca­pac­i­ty that will be ready to op­er­ate in 2022.

In Sep­tem­ber, the com­pa­ny an­nounced man­u­fac­tur­ing in­vest­ments at three of its sites, in­clud­ing the Visp lo­ca­tion. It’s al­ready ex­pand­ed in Chi­na, New Hamp­shire and the Nether­lands as well, to help sup­port its dou­bling of mR­NA drug sub­stance man­u­fac­tur­ing, as it has worked close­ly with Mod­er­na. At one point, Lon­za called up­on fed­er­al work­ers and some from lo­cal uni­ver­si­ties to sup­ple­ment its work­force in Visp, even bor­row­ing work­ers from food gi­ant Nestlé, cov­er­ing food, salary, trav­el and lodg­ing for about 75 work­ers while it looked for a long-term so­lu­tion to its staffing woes.

The com­pa­ny al­so an­nounced a man­u­fac­tur­ing part­ner­ship with Blue­Jay last week, a de­vel­op­er of ther­a­peu­tics to treat he­pati­tis B in­fec­tion. The deal will al­low Lon­za to make BJT-778, one of the com­pa­ny’s lead can­di­dates, an mAb that tar­gets the sur­face anti­gen HB­sAg. The agree­ment will cov­er the ear­ly stages from gene man­u­fac­tur­ing to IND, and pro­vide cell line, process and an­a­lyt­i­cal de­vel­op­ment at the Visp, Basel and Stein, Chi­na sites.

Jee­tendra Vaghjiani, the ex­ec­u­tive di­rec­tor of clin­i­cal de­vel­op­ment and strate­gic mar­ket­ing, said in a press re­lease:

“This col­lab­o­ra­tion sig­ni­fies our com­mit­ment and flex­i­bil­i­ty in ac­com­mo­dat­ing the spe­cif­ic and unique needs of emerg­ing biotechs tak­ing their lead can­di­date to clin­ic. Our team has ex­ten­sive ex­per­tise to set up a cus­tomized for­mu­la­tion plat­form, proac­tive­ly an­tic­i­pate risks and sug­gest mit­i­ga­tion mea­sures that will help move Blue­Jay’s can­di­date from pre­clin­i­cal stages in­to the clin­ic.”

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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One work­er at a Lat­vian man­u­fac­tur­er is dead af­ter a fire breaks out at fa­cil­i­ty

A press release referred to it as simply, “the incident.” But a fire at an Olainfarm site in Latvia last week has left one person dead, and injured another, the company announced Monday.

Just before midnight Nov. 26, a fire broke out in the production building of JSC Olainfarm,  as the result of an “accident,” a company spokesperson said in an email to Endpoints News. The two victims were both company employees, and the causes of the accident are still being determined.

Fu­ji­film Diosynth dumps an­oth­er $454M in­to its sup­ply chain, this time at a fa­cil­i­ty in the UK

Fujifilm Diosynth Biotechnologies is in the middle of a monumental point in the company’s 10-year history, and the CDMO is about to grow even more, as it sets out to be the “beating heart” of the UK’s North East Life Sciences ecosystem.

A site in Billingham, Teeside, UK will receive a $453.72 million investment package from the manufacturer to double the existing footprint and create the largest multi-modal biopharmaceutical manufacturing site in the UK, bringing another 350 jobs to the region by late 2023.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.