Keeping cleanrooms clean: Choosing the right laboratory equipment is key

 Because live cell and tissue products are sensitive to contamination from microorganisms, viral particles or other  impurities, research and manufacturing involving these materials needs to be conducted in a cleanroom environment.

April 15, 2024

Novartis pauses enrollment in some Kisqali trials to fix manufacturing

The company said the pause is necessary to meet regulatory limits on nitrosamine, but added it will not affect commercial supply nor regulatory review of the drug in early breast cancer.

By Jonathan Gardner • April 10, 2024

BIO changes stance, backs bill to limit China’s role in US biotech

Pressed by lawmakers, the lobbying group is also “taking steps” to end its relationship with WuXi-AppTec, a major contract manufacturer to the biopharmaceutical industry.

By Jonathan Gardner • March 14, 2024

Advanced technologies in unlocking the future of drug manufacturing

Innovative technologies, such as flow chemistry and biocatalysis, are achieving not only sustainability goals but also unprecedented levels of quality and efficiency.

By Jon Brice, PhD • March 11, 2024

BioNTech partners with Autolus to boost cell therapy manufacturing

The German biotech will invest $200 million in Autolus — funds that, along with a $50 million fee, give it licensing options and access to supply infrastructure.

By Kristin Jensen • Feb. 8, 2024

Fujifilm to invest $200M in cell therapy production

The funds are meant to boost Fujifilm’s capacity to manufacture cell therapies, a market it expects to grow substantially in the coming years.

By Delilah Alvarado • Dec. 6, 2023

Novo to expand French plant in GLP-1 production push

The planned $2.3 billion investment follows an earlier $6 billion commitment to expand manufacturing for drugs like its in-demand medicine Wegovy.

By Delilah Alvarado • Nov. 27, 2023

Data infrastructure excellence changing the shape of biopharma manufacturing

Biopharma companies capture data across a variety of different fronts and, so this data must be managed effectively in order to unlock business efficiencies and drive improvements.

Nov. 20, 2023

Lilly plans new $2.5B manufacturing plant as obesity drug demand ramps up

Following the approval of Zepbound, Lilly is adding capacity to avert shortages and restricted access.

By Jonathan Gardner • Nov. 17, 2023

3 things manufacturers need to know about the new Annex 1 revision

As biopharmaceutical organizations around the globe adjust to the new guidelines, Baroni shared insights on three things they need to know about Annex 1.

Nov. 13, 2023

Novo takes aim at obesity drug shortages with $6B manufacturing plan

The maker of Wegovy and Ozempic plans to expand production in its home country of Denmark to help meet surging demand for the GLP-1 drugs.

By Ned Pagliarulo • Nov. 10, 2023

Futureproofing your lab to meet tomorrow’s sustainability standards

Industry-leading cold storage manufacturers are engineering new solutions that can reliably meet performance benchmarks while consuming far less energy than yesterday’s ULT and laboratory-grade freezers.

Nov. 6, 2023

[Podcast] Secure Innovation: How Life Sciences and Pharmaceutical Companies Can Safely Seize Opportunity

This podcast series explores how life sciences companies can bolster their cybersecurity while growing their business.

Updated Dec. 19, 2023

With $56M, a Mayo Clinic-backed startup takes aim at radiopharmaceutical roadblocks

Nucleus RadioPharma, a contract developer and manufacturer, is expanding at a time when investment is pouring into the radiopharmaceutical drug field.

By Gwendolyn Wu • Oct. 17, 2023

Bayer opens California plant to make cell therapies

The pharma plans for the new Berkeley facility to produce clinical, and potentially commercial, supplies of a Parkinson’s disease cell therapy being tested by its subsidiary BlueRock. 

By Delilah Alvarado • Oct. 10, 2023

Using real-world data to improve patient access to oncology therapies

Oncology manufacturers can improve access by using claims, labs, pathway and policy data to address misalignment. 

By Carolyn Zele, Solution Consulting Advisor, MMIT • Oct. 9, 2023

Lilly eczema drug turned back by FDA over manufacturing

The rejection of lebrikizumab is Lilly’s second for an immunology drug this year, following a complete response letter for mirikizumab in April. 

By Delilah Alvarado • Oct. 2, 2023

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

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

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