FDA in­spec­tion of Emer­gent’s Bal­ti­more site in 2020 rais­es new ques­tions

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.”

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.

FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Paul Chaplin, Bavarian Nordic CEO

Bavar­i­an Nordic nets ma­jor vac­cine con­tract to re­spond to mon­key­pox out­break

The current monkeypox outbreak is now at a phase where some governments are approaching a point of concern, at least enough to start stockpiling vaccines.

In response, at least one government is placing its order with vaccine manufacturer Bavarian Nordic to secure sufficient supply for vaccinating individuals. According to the company, it has inked a supply contract with an undisclosed country for the company’s smallpox vaccine, called Jynneos. The aim is to ensure there will be enough supply to meet the undisclosed country’s requirements for vaccinating individuals at risk for monkeypox in the short to medium term. The vaccine is approved for use against monkeypox by the FDA and Health Canada.

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.

Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.