Manufacturing: Page 2
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Sponsored by BioPharmaSpec
Process-related impurities: Looking beyond the API for safer biotherapeutics
De-risk your biomanufacturing- an essential mini-guide to detection and quantitation of residuals.
Oct. 2, 2023 -
Novo Nordisk parent backs cell therapy manufacturing facility
The Novo Nordisk Foundation’s planned manufacturing facility will help both private companies and academic researchers develop new cell therapies.
By Jonathan Gardner • Sept. 21, 2023 -
Sponsored by OM1
Reclaiming registries for integrated evidence generation throughout the product life cycle
As integrated evidence generation takes center stage for driving evidence-based decision making across the product life cycle, automated registries just might be the linchpin that pulls it all together.
By Richard Gliklich, MD, CEO, OM1 • Sept. 18, 2023 -
Manufacturing delays under-the-skin Tecentriq shot in US
Roche says it won’t be able to launch the subcutaneous version of the drug until 2024 as it works with the FDA on manufacturing updates.
By Jonathan Gardner • Sept. 8, 2023 -
Catalent expands board in deal with activist investor Elliott
The CDMO is adding four new independent directors to its board, and has set up a committee to review its business and capital allocation priorities.
By Ned Pagliarulo • Aug. 29, 2023 -
Startup Cellares adds $255M as investors pour cash into cell therapy production
Bristol Myers Squibb is among those backing the company, which claims the manufacturing capacity at its New Jersey plant can surpass that of conventional CDMO facilities.
By Kristin Jensen • Aug. 24, 2023 -
Sponsored by MilliporeSigma
5 ways experience matters in gene therapy manufacturing
By partnering with an accomplished CTDMO, gene therapy innovators can benefit from guidance and support.
Aug. 21, 2023 -
Emergent to lay off around 400 in pivot away from contract manufacturing
The job cuts will affect “all areas of the company” and, combined with other cost-reduction efforts, lead to annualized savings of over $100 million, Emergent said.
By Jacob Bell • Aug. 8, 2023 -
Sponsored by Center for Breakthrough Medicines
Cell and gene therapy is coming of age
Outsourcing in the cell and gene therapy industry is booming and no longer considered just a “trend.”
July 24, 2023 -
Sponsored by Altasciences
Optimize your drug development timeline with liquid-filled, hard-shell capsules
With this highly marketable dosage form, scientists can effectively formulate poorly soluble drugs and supplements, while reducing development time and costs.
July 17, 2023 -
Sponsored by Center for Breakthrough Medicines
Overcoming AAV manufacturing challenges
Overcome issues with AAV vector scalability and reproducibility. Enable a wider application of gene therapies in a cost-effective and sustainable way.
July 10, 2023 -
Sponsored by Emergent
4 steps for a smooth tech transfer when working with a CDMO
When developing a new drug product, quality, safety and timing are critical. A CDMO can be a valuable partner to help mitigate risks.
June 20, 2023 -
Ferring, with manufacturing update, takes a step towards first gene therapy sales
The FDA has cleared Ferring’s planned scale-up process for its bladder cancer treatment Adstiladrin, which the company plans to make available in the U.S. later this year.
By Delilah Alvarado • June 13, 2023 -
Novo Nordisk to invest over $2B in drug ingredient production
The company said the spending will help it manufacture future treatments for chronic diseases, adding to a string of recent plant investments.
By Delilah Alvarado • June 12, 2023 -
Pharmaceutical supply chains raise data concerns as traceability law nears final step
Companies have had 10 years to comply with the Drug Supply Chain Security Act, but some fear the industry is not ready for a Nov. 27 deadline.
By Deborah Abrams Kaplan • June 7, 2023 -
Catalent cuts outlook, delays results as it reveals new hurdles
The pharmaceutical CDMO said it found “significant” issues with its forecasts over the past year, compounding manufacturing problems at three of its plants.
By Ned Pagliarulo • May 8, 2023 -
Baxter to sell biopharma unit to private equity for $4.25B
The deal is the latest in a string of private equity-backed deals for contract development and manufacturing businesses in the pharmaceutical sector.
By Elise Reuter • May 8, 2023 -
Novo reveals another setback in obesity drug’s launch
U.S. supply of Novo’s Wegovy will be “reduced temporarily,” while the Danish drugmaker gets a new contract manufacturer up and running, executives said.
By Jonathan Gardner • May 4, 2023 -
Pfizer turns focus to new drugs as COVID vaccine revenue falls
The drugmaker beat Wall Street’s first quarter forecasts despite a sales drop that puts pressure on it to succeed with upcoming market launches.
By Jonathan Gardner • May 2, 2023 -
Bristol Myers boosts cell therapy production with Novartis plant
Accessing the Illinois facility will expand Bristol Myers’ supply of viral vectors following manufacturing struggles with CAR-T drugs Abecma and Breyanzi.
By Kristin Jensen • April 26, 2023 -
Novartis plant cleared to produce in-demand cancer drug
The FDA has approved the pharma, which has had difficulty producing radiopharmaceutical drugs, to make its treatment Pluvicto at a New Jersey site.
By Delilah Alvarado • April 24, 2023 -
FDA again knocks back Alvotech’s Humira biosimilar
The agency rejected the partners’ copycat version of AbbVie’s blockbuster drug for a second time, citing problems spotted during the inspection of a manufacturing facility.
By Jonathan Gardner • April 14, 2023 -
Pharma partner Sartorius eyes gene therapy market with $2.6B deal
The biotech tools supplier is acquiring Polyplus, a French company that makes components essential to the viral vector backbones of gene therapies.
By Ned Pagliarulo • March 31, 2023 -
Sponsored by West Pharmaceutical Services
Early decisions to de-risk the transition to combination products
Speeding up the drug development process through a less optimized containment and delivery system may have been an option in the past, but both expectations and the competitive environment are changing.
March 20, 2023 -
Sponsored by MilliporeSigma
Addressing manufacturing challenges in gene therapy development
As new gene therapies are developed to treat a growing number of indications, patients may soon have access to novel treatment options and potential cures.
By Kate Silver • March 20, 2023