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CD­MO Ster­ling ac­quires ADC Bio, ramp­ing up ca­pac­i­ty for an­ti­body-drug con­ju­gate man­u­fac­tur­ing work

Sterling Pharma Solutions has announced the acquisition of ADC Bio, a UK-based company that specializes in antibody drug conjugates. ADC’s Wales manufacturing facility will rebrand to become part of the Sterling network, the companies said.

ADC will start work as part of the Sterling network as early as 2022. The move allows Sterling to integrate the new facility’s highly potent API capabilities to develop and manufacture toxin linkers, according to a release.

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.

Re­call re­port: A-S pulls near­ly 200,000 ac­eta­minophen bot­tles off shelves; Apo­tex yanks AD­HD med

Another company has been forced to recall bottles of its product after a labeling misstep.

A-S Medication Solutions is voluntarily recalling 100 count bottles of its Acetaminophen Extra Strength 500 mg tablets after reports that the bottle contains an incomplete prescription drug label as opposed to the required over-the-counter drug facts label. The recall is expected to be on 198,350 bottles of the pain and fever reliever.

Catal­ent pledges to in­crease pro­duc­tion of Mod­er­na vac­cine at its In­di­ana fill-fin­ish plant

One of the big contract partners in the Covid-19 effort, Catalent has signed deals with most of the major vaccine players to help ramp up supply. Now, the New Jersey firm will expand its deal with Moderna in hopes of churning out double the amount of finished vials in time for summer.

The CDMO will increase its production capacity of the vaccine in its Bloomington, IN biologics facility through its new high-speed vial filling line, Catalent announced Tuesday. Sources close to the matter told The Wall Street Journal that agreement will increase the vaccine output in April to 400 vials a minute.

UP­DAT­ED: 2,400 peo­ple re­main with­out rare dis­ease drug as Take­da man­u­fac­tur­ing woes con­tin­ue

Since September 2019, 2,400 people with the rare condition known as hypoparathyroidism have been waiting for any sign that supplies of their reliable injection from Takeda might reemerge.

Last Wednesday, however, Takeda announced that supplies won’t be ready for at least another year, stranding those who still can’t access the drug, known as Natpara (parathyroid hormone), via the company’s Special Use Program (SUP), which is only for about 400 of those who are at extreme risk of life-threatening complications.

Image: AP Images

UP­DAT­ED: Af­ter mil­lions of Covid vac­cine dos­es were botched, the feds hand con­trol of a trou­bled Emer­gent Bio fa­cil­i­ty to J&J

Emergent BioSolutions has lost control of one of the principal US plants designated to make Covid-19 vaccines.

After mixing up vaccines from AstraZeneca and J&J, botching up to 15 million doses, J&J is now moving in its own manufacturing team — at the direction of the feds — to run Emergent’s troubled Bayview plant in Baltimore, which has been tagged for multiple operating violations.

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Patrick Walsh, Alcami

Al­ca­mi ap­points new CEO in Patrick Walsh, the ex­ec­u­tive who helped lead the CD­MO's pre­de­ces­sor com­pa­ny

While North Carolina-based Alcami only came into existence back in 2016, the company has looked to keep expanding as the market for contract work in biopharma continues to grow. To get it there, it’s tapping an old friend — the executive who helped chart the company on its current path.

Alcami named Patrick Walsh as its newest CEO on March 18. Walsh previously served as CEO of AAI Pharma, the predecessor company that eventually became Alcami, between 2010 and 2014.

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Pfiz­er breaks ground on ster­ile in­jecta­bles plant in Michi­gan, plans to add around 450 jobs to the re­gion

With Covid-19 continuing to crunch hospital resources, drugmakers are stepping into the breach to up production of sterile injectables used for hospital medicines. Now, Pfizer is boots on the ground for a massive project in Michigan that will help lead the way for its own push to expand in the field.

Pfizer has broken ground on a 420,000-square-foot sterile injectables plant in Kalamazoo, Michigan, that the drugmaker estimates will bring around 450 new jobs to the region, the company said Wednesday.

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Covid-19 man­u­fac­tur­ing roundup: Catal­ent gets the FDA's go-ahead on J&J shot; As­traZeneca taps a new con­trac­tor

The FDA has authorized an Indiana CDMO to produce and ship millions of doses of J&J’s Covid-19 vaccine.

Catalent Pharma tweeted the news and an accompanying video from its Bloomington facility last week. The manufacturer received a EUA, which puts J&J a step closer toward meeting its goal of providing the US with 100 million doses by the end of June.

Covid-19 roundup: Emer­gen­t's er­ror costs J&J a vac­cine batch; Pfiz­er head says EU re­stric­tions slow vac­cine dis­tri­b­u­tion process

J&J has run into a snag in production of its Covid-19 vaccine after its quality patrol spotted problems with one batch of drug substance.

The issue — which the New York Times reported was due to a mix-up between the vectors used in J&J and AstraZeneca’s vaccines — sent J&J into trouble-shooting mode. The company said it’s sending additional experts in manufacturing, technical operations and quality to supervise onsite at Emergent’s Bayview facility, which was once touted for its capacity to rapidly scale manufacturing.