The FDA on Thurs­day raised fresh qual­i­ty con­cerns about Emer­gent BioSo­lu­tions’ man­u­fac­tur­ing site in Bal­ti­more, which has more re­cent­ly been tak­en over by J&J af­ter an er­ror caused the site to dis­card about 15 mil­lion dos­es of the com­pa­ny’s vac­cine last month.

Ac­cord­ing to a Form 483 is­sued to the con­tract test­ing lab last April, fol­low­ing a 7-day in­spec­tion and just re­leased by the FDA, Emer­gent’s qual­i­ty unit failed to en­sure some very ba­sic, fun­da­men­tal ac­tiv­i­ties, like that staff couldn’t just delete or ma­nip­u­late elec­tron­ic da­ta, and the re­spon­si­bil­i­ties and pro­ce­dures for the qual­i­ty unit were not in writ­ing or ful­ly fol­lowed, FDA said.

“At the time of this in­spec­tion, no in­ves­ti­ga­tions had been per­formed to as­sess the im­pact of the da­ta dele­tions, mod­i­fi­ca­tions or the fail­ure to re­view sys­tem au­dit trails on drug sub­stance and drug prod­uct an­a­lyzed un­til ap­prox­i­mate­ly, De­cem­ber 2019,” the Form 483 signed by FDA in­ves­ti­ga­tor Mar­celli­nus Dor­dunoo says.

What’s more, the 483 high­lights the site’s in­abil­i­ty to pre­vent mix-ups of in­gre­di­ents or con­t­a­m­i­na­tion. The site’s mix-up of J&J and As­traZeneca drug sub­stance is what caused the mil­lions of dos­es to be thrown out.

“Sep­a­rate or de­fined ar­eas to pre­vent con­t­a­m­i­na­tion or mix-ups are de­fi­cient re­gard­ing op­er­a­tions re­lat­ed to the hold­ing of re­ject­ed com­po­nents be­fore dis­po­si­tion,” FDA said.

The com­pa­ny’s com­put­ers al­so did not pre­vent users from chang­ing the sys­tem date and time, mean­ing they could al­ter pre­vi­ous work as though they were work­ing in re­al time.

“Dur­ing the bio­chem­istry lab­o­ra­to­ry walk-through, it was ob­served that the present time-zone and sub­se­quent­ly, the date and time was able to be mod­i­fied,” FDA notes. The agency al­so found em­ploy­ees work­ing in the site’s bio­chem­istry lab who were not doc­u­ment­ed as be­ing trained on the firm’s writ­ten pro­ce­dures or test meth­ods.

An­oth­er ob­ser­va­tion notes that sam­ple iden­ti­fi­ca­tion num­bers “were ob­served to be man­u­al­ly cor­rect­ed, mul­ti­ple days af­ter da­ta ac­qui­si­tion” and the com­pa­ny did not per­form an in­ves­ti­ga­tion.

The Form 483 of­fers a peek be­hind the cur­tain on a site that has gar­nered lots of re­cent neg­a­tive at­ten­tion. Last Sat­ur­day, As­traZeneca, un­der the di­rec­tion of the US gov­ern­ment, an­nounced that it will re­lo­cate pro­duc­tion of its vac­cine drug sub­stance from the Emer­gent fa­cil­i­ty, but has yet to an­nounce a new site. No­vavax al­so pre­vi­ous­ly re­lo­cat­ed pro­duc­tion of its vac­cine from Emer­gent to Fu­ji­film.

An­oth­er out­side re­port on the site from last June, first ex­plained in de­tail by the New York Times, not­ed the fac­to­ry’s prob­lems “will re­quire sig­nif­i­cant ef­fort,” and the com­pa­ny “will have to be mon­i­tored close­ly.”

An Emer­gent spokesper­son said in a state­ment, “We have worked and con­tin­ue to work close­ly with the fed­er­al gov­ern­ment in sup­port of the COVID re­sponse. These FDA ob­ser­va­tions were ad­dressed and re­viewed in de­tail with FDA dur­ing their re­cent site vis­its in Sep­tem­ber 2020 and Feb­ru­ary 2021.”

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The FDA and CDC have jointly decided to stop administering J&J’s Covid-19 vaccine after reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement Tuesday morning.

As co-director of an experimental cellular therapy process development and manufacturing group at UCSF specializing in T cell therapies for autoimmune conditions, Jonathan Esensten has learned a lot about the challenges involved when his group hand-fashions a cell therapy. Esensten — who was a postdoc in Wendell Lim’s lab and counts the legendary Jeffrey Bluestone as a mentor — gives them all high marks at being great at what they do, but time and again there are variations in the treatments they construct.

There’s another unicorn in biotech land, as Benchling and its leading R&D cloud platform pull in a $200 million Series E to help scientists accelerate drug development. In doing so, the company hit a lofty $4 billion valuation — nearly five times what it was worth around this time last year, according to Forbes.

Despite the fact that drug development is becoming significantly more complex, the industry continues to run on paper, emails and spreadsheets, co-founder and CEO Sajith Wickramasekara said in a video on Benchling’s website. The MIT grad sought to change that by creating software that allows scientists to better track, model and forecast their work.

Novavax has had a busy month, filled with supply chain issues and manufacturing deals that have affected the rollout of its Covid-19 vaccine. Tuesday, the company announced updates to its leadership team.

CFO Greg Covino will step down from that role after just five months for personal reasons, the release said, but take on a new role as executive advisor. John Trizzino, current chief commercial officer and chief business officer, will take the CFO role over in the interim.

Amylyx is one of several companies looking to break through in the tough ALS field, and Wednesday they announced they’re moving forward with regulatory plans.

The Cambridge, MA-based biotech said they’re submitting a marketing application to the EMA for their AMX0035 program by the end of 2021. Wednesday’s news comes a few weeks after they revealed similar plans to move forward with Canadian health regulators by June 30.