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

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

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

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

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

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

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

Sandoz, betting on biosimilar sales, to build new production plant

The Novartis division will invest at least $400 million in a new manufacturing facility in Slovenia amid expectations that demand for copycat biologics will surge in the coming years.

By Delilah Alvarado • March 9, 2023

Novartis takes step toward expanding supply of in-demand cancer drug

The company has struggled to maintain supply of its prostate cancer drug Pluvicto, hampered by production issues and higher-than-expected demand.

By Delilah Alvarado • March 3, 2023

A startup launches with plans to open up a gene and cell therapy bottleneck

The pipeline of CAR-T therapies and ex vivo gene therapies has swelled in recent years, but manufacturing hasn’t been able to keep up with demand.

By Gwendolyn Wu • Jan. 31, 2023

Lilly to boost diabetes drug production with $450M factory investment

The pharma aims to double its manufacturing capacity for drugs like Mounjaro and Trulicity as competition with rival Novo Nordisk heats up.

By Jonathan Gardner • Jan. 24, 2023

The inspection challenges posed by the self-administration trend

Automatic visual inspection: rising to the challenges of syringe inspection. 

Dec. 19, 2022

Novo Nordisk to boost drug manufacturing in Denmark

The Danish drugmaker has invested heavily in expanding its production capacity for oral and injectable drugs. A new $744 million project is the latest investment.

By Christopher Newman • Nov. 22, 2022