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David Enloe, Recro Pharma CEO

Re­cro takes on big broth­er role with opi­oid ad­dic­tion drug mak­er, han­dling man­u­fac­tur­ing du­ties and ad­vis­ing on FDA work

Just three weeks ago, CDMO Recro Pharma expanded its footprint to the West Coast, as it acquired San Diego-based Irisys for $50 million cash. The deal helped the company branch out into a broader set of dosage forms — and now that buyout is already bearing fruit.

Recro will serve as both an advisor to BioCorRx in its small molecule development for its opiate addiction treatment drug, dubbed Bicx104, in addition to manufacturing it. The subcutaneous pellet of naltrexone has been given the OK by the FDA to start in-person trials, largely funded by the National Institute on Drug Abuse and the NIH.

Ther­mo Fish­er, as part of glob­al ex­pan­sion plans, out­lines new sin­gle-use site in Nashville

Thermo Fisher Scientific is headed to the Music City.

The drug manufacturer will establish a single-use technology site in Nashville, TN, which it says will be one of the largest in the world and will double the company’s single-use manufacturing capacity.

Construction will start by Q2 2022. The site is a part of Thermo Fisher’s larger picture: a $650 million investment in bioprocessing production at 11 sites on three continents. Projects in Logan, UT, Suzhou, China, and Singapore are set to be completed by the end of this year, and expansions are on the books in New York, Miami and Scotland.

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Covid-19 man­u­fac­tur­ing roundup: Rus­sia will pro­duce Sput­nik V in Pe­ru — re­port; CEPI calls for es­tab­lished vac­cine use in tri­als

Peru will install a manufacturing plant in-country to produce the Sputnik V Covid-19 vaccine out of Russia, its President Pedro Castillo announced Monday.

Just about 25% of the population is fully vaccinated, while 33% has received at least one jab. Since August, the daily infection rate has hovered around the 1,000 mark.

Russia and Peru inked a deal for 20 million doses of Sputnik V in July.

Brazil just backed out of an agreement for the vaccine, citing a lapsed registration deadline, despite battling one of the toughest outbreaks in the world. Sputnik V is still awaiting emergency use authorization from the World Health Organization. In June, the agency took issue with its vial-filling procedures at a plant. A report identified problems surrounding the risk of cross-contamination and said that tracking and identifying batches of the vaccine was a concern.

Re­call re­port: Amino acid IV pulled af­ter hair, oth­er for­eign sub­stances found in batch

A California infusion therapy company is voluntarily recalling one lot of an amino acid injection made by Pfizer spinout company Hospira after reports of fibers, hair and other particles of foreign materials were found in the solution.

ICU Medical recalled 2,112 units of Aminosyn II, 15%, after it became aware of the issue while inspecting samples as part of a routine process, the FDA said. The administration of a drug with particulates that do not belong can cause side effects ranging from inflammation at the point of injection to blood clots. So far, ICU Medical hasn’t reported any side effects or illnesses stemming from the contamination.

Rahul Singhvi, Resilience CEO

Months af­ter land­ing Cana­di­an site from gov­ern­ment, Re­silience an­nounces a big mR­NA part­ner

Bob Nelsen’s latest project, dreamed up out of anger, has been focused on becoming the Amazon Web Services of drug manufacturing, with the ability to scale in the most efficient way possible. It has now partnered with one of the most influential players in the pandemic response.

Resilience will start making mRNA for Moderna’s Covid-19 vaccine at its new site in Canada, the company announced Wednesday.

With in­dus­try's bless­ing, FDA launch­es nov­el ex­cip­i­ent re­view pi­lot pro­gram

The FDA on Tuesday launched a new pilot program that will initially review four novel excipients over two years, with an eye toward helping drug developers in situations where existing excipients may be difficult to employ.

The plan for such a pilot has been in the works since at least 2019, as the FDA does not currently review new excipients as part of an IND or a marketing application, although some novel excipients may provide public health benefits, such as improved drug delivery or potentially abuse-deterrent properties that could be key for new opioid formulations.

Michael Stubblefield, Avantor CEO

Dou­bling down on need for mR­NA vac­cines and mAbs, Avan­tor puts near­ly $3B in pumps and tub­ing com­pa­ny

Acquisition-happy manufacturer Avantor has positioned itself at the front of the battle against Covid-19, and Tuesday it made another move to embed itself deeper into the ongoing pandemic response.

Pennsylvania-based Avantor acquired Masterflex from Antylia Scientific for $2.7 billion in an all-cash transaction, the company announced. The acquisition is Avantor’s 43rd overall, as it has put more than $11 billion into projects since 2011, the company said, with this transaction aiming to be completed in the fourth quarter.

Andy Scharenberg, Umoja

Hot off of a $210M Se­ries B, Umo­ja breaks ground in Col­orado on CAR-T site

Boulder County, CO, is getting a new manufacturing facility, and it will come from a Seattle oncology company focused on CAR T-cell immunotherapies.

Umoja Biopharma broke ground on a new facility for in vivo immunotherapies for solid tumors and hematologic malignancies, the company announced Monday. The site is the company’s next step toward bringing CAR-T therapies to cancer patients. The 146,000-square-foot facility will have labs, offices and space for lentiviral vector production.

Rick Jackson (second from left), Bob Rolfe (fourth from left) and US Rep. Diana Harshbarger, R-TN, are were among those on hand in Bristol, TN for the ribbon cutting to USAntibiotics reopening Monday

As bank­rupt­cy neared, work­ers at a US­An­tibi­otics site worked un­til the lights went out. Now, the site will get a sec­ond life

Linda Robbins, the VP of Quality and Regulatory Affairs at USAntibiotics in Bristol, TN was faced with a problem.

The world-class antibiotics facility where she’d worked for the last 30 years was going to shut down. So for five weeks, right up until the point of the lights being shut off, she and her team worked without pay, continuing to package products that had not yet been sealed and keep operations going for as long as possible.

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Covid-19 man­u­fac­tur­ing roundup: Stain­less steel iden­ti­fied as for­eign item in Japan­ese Mod­er­na lots; DoD con­tract en­ables pipette man­u­fac­tur­ing

After more than 1.6 million doses of Moderna’s Covid-19 vaccine were suspended last week in Japan, the country’s health ministry has identified the suspect particles and said it will not pose a larger health risk.

Findings Wednesday revealed that the metallic material inside the vials of vaccines was stainless steel, a material Moderna says does not pose additional health risks to patients. Takeda plans to recall the three affected lots of the vaccine, Moderna said Wednesday.