Manufacturing: Page 19
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Boehringer building out biologics manufacturing in China
The expansion of Boehringer's OASIS plant includes another bioreactor and the infrastructure to support two 2,000-liter single-use bioreactor production lines.
By Jacob Bell • Jan. 17, 2019 -
AmerisourceBergen subsidiary laying off hundreds at compounding plant
The company will cut about half its workforce at a Tennessee-based facility, which has been suspended due to concerns flagged by the FDA last year.
By Suzanne Elvidge • Jan. 17, 2019 -
EPA: Pharmaceuticals in reverse supply chain are hazardous waste
A new regulation could prompt uncertainty as players in the pharmaceutical supply chain evaluate compliance.
By Gary Wollenhaupt • Jan. 14, 2019 -
FDA expands excepted activities as government shutdown drags on
As days stretch into weeks, Commissioner Scott Gottlieb and his agency are battling to not let the shutdown hurt food and drug safety.
By Suzanne Elvidge • Jan. 14, 2019 -
Akorn's drug pipeline 'held hostage' with FDA warning letter
The agency detailed numerous violations against the generic manufacturer's plant in Decatur, Illinois.
By Kristin Jensen • Jan. 10, 2019 -
Yujin Kim/BioPharma Dive
Q&ASpark looks at scale, manufacturing as gene therapy matures
Though Luxturna only recently hit the market, Spark is already at work validating new ways of scaling up manufacturing.
By Jacob Bell • Jan. 10, 2019 -
Catalent to invest $200M in biologics manufacturing, creating 300 US jobs
The move follows a $14 million investment in Bloomington, Indiana, to boost packaging offerings.
By Kristin Jensen • Jan. 8, 2019 -
Sarepta inks deal to bolster gene therapy manufacturing
An agreement with Aldevron may help the biotech avoid setbacks like the short-lived clinical hold it received on a gene therapy candidate last year.
By Suzanne Elvidge • Jan. 3, 2019 -
Our 10 best stories of 2018
Pharma boards, cell therapy, AI and cancer drug ads feature in BioPharma Dive's top articles of the past 12 months.
By Ned Pagliarulo • Dec. 21, 2018 -
Novartis seeks to acquire French CAR-T contract manufacturer
CellforCure already works with Novartis on clinical production of Kymriah, a therapy that has hit manufacturing hurdles in its rollout.
By Ned Pagliarulo • Dec. 20, 2018 -
Recipharm considering closing UK plant, could affect 140 workers
The CEO said the facility in Greater Manchester, England, had "no likely prospect" to deliver "acceptable return in the medium term."
By Andrew Dunn • Dec. 20, 2018 -
Sen. Warren proposes government manufacture generics
Democratic Sen. Elizabeth Warren is pitching a radical way to cut drug prices for the U.S. budget — the government manufacturing its own generics.
By Suzanne Elvidge • Dec. 19, 2018 -
Sponsored by MilliporeSigma
New education program to accelerate industry next-gen processing
Employee training is critical as organizations implement next-generation technologies to create new products and streamline their operations across departments.
Dec. 17, 2018 -
Troubled Pfizer plant faces more criticism in Form 483
Despite Pfizer's talk of remediation and improvement, regulators have found a slate of repeat manufacturing violations at its Kansas facility.
By Suzanne Elvidge • Dec. 13, 2018 -
FDA keeps spotlight on GMP data integrity
New guidance from the FDA is aimed at helping manufacturers stay on the agency's good side when it comes to ensuring data are secure and accurate.
By Suzanne Elvidge • Dec. 13, 2018 -
Orchard to build gene therapy manufacturing plant in California
The planned investment comes months after Orchard struck a deal with GSK to take over development of the British pharma's gene therapy drugs.
By Kristin Jensen • Dec. 13, 2018 -
Chinese company at heart of valsartan investigation hit with warning letter
The FDA laid out its concerns with Zhejiang Huahai, putting the onus firmly on the Chinese manufacturer to clean up its act.
By Suzanne Elvidge • Dec. 12, 2018 -
Lonza bets on China biotech market with plans for new plant
A crop of emerging Chinese biotechs are pushing into novel drug development, increasing demand for CDMO services in a country long known for its API manufacturing.
By Andrew Dunn • Dec. 10, 2018 -
Kendall Davis/BioPharma Dive
J&J, Merck back new UK vaccine manufacturing center
The center, which should open in early 2022, aims to ensure a supply of emergency pandemic vaccines for the U.K.
By Suzanne Elvidge • Dec. 6, 2018 -
Novo Nordisk to invest $22M in North Carolina diabetes plant
Another round of investment will bring more jobs to the site, which is a central piece of the Danish drugmaker's operations in the U.S.
By Suzanne Elvidge • Dec. 6, 2018 -
Masthercell doubles capacity in production build-out
With the expansion, the CDMO aims to better support its cell therapy-focused clients as they advance candidates through testing.
By Suzanne Elvidge • Dec. 6, 2018 -
In CAR-T, manufacturing a hurdle Novartis has yet to clear
In an interview, Novartis' cell and gene therapy head said the pharma's made "significant progress" addressing issues that have hampered Kymriah's roll-out.
By Ned Pagliarulo • Dec. 6, 2018 -
FDA
Catalent boosts biologics packaging with $14M investment at Indiana site
Following the 20th commercial drug approval from its recently acquired Bloomington plant, Catalent is planning a 15,000-square-foot expansion to beef up CDMO capabilities.
By Suzanne Elvidge • Dec. 5, 2018 -
Sun Pharma acquires two manufacturing plants in deal for Japanese company
Acquiring Pola Pharma won't cost the Indian generics maker much, and boosts its dermatology presence in Japan.
By Suzanne Elvidge • Nov. 29, 2018 -
GE Healthcare opens new manufacturing center in England
While a small addition, the increased footprint in Stevenage is yet another sign of the corporate giant's interest in biopharmaceuticals and complex therapies.
By Suzanne Elvidge • Nov. 29, 2018
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