Manufacturing
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As drug shortages reach record highs, regulators weigh next steps
With many chemotherapy and ADHD drugs stuck in stubbornly short supply, several agencies are looking for new solutions.
By Kelly Bilodeau • May 6, 2024 -
Obesity drugs
Lilly counts on manufacturing scale-up to unstick obesity drug supply
Increasing the production capacity for Zepbound and Mounjaro is “the most ambitious expansion plan in our company’s history,” said CEO David Ricks.
By Jonathan Gardner • April 30, 2024 -
Sponsored by Asymchem
Sustainability in pharmaceutical manufacturing: a CDMO’s contribution
Consideration of sustainability early in process development, throughout the entire development cycle, and across the entire supply chain must also become common practice.
By Mark McLaws, Ph.D. – Vice President CMC & Development, Asymchem • April 29, 2024 -
Lilly to buy injectable drug plant in manufacturing ramp-up
The acquisition of a Nexus Pharmaceuticals facility in Wisconsin could help Lilly better meet demand for injectable medicines, like those it makes for diabetes and obesity.
By Delilah Alvarado • April 22, 2024 -
Bristol Myers taps startup to boost cell therapy production
A partnership with Cellares, worth up to $380 million, is meant to help Bristol Myers speed and scale manufacture of CAR-T treatments for cancer.
By Ned Pagliarulo • April 22, 2024 -
Sponsored by PHC Corporation of North America (PHCNA)
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 -
Sponsored by Asymchem
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 -
Sponsored by Cognizant
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 -
Sponsored by Emergent
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 -
Obesity drugs
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 -
Sponsored by PHC Corporation of North America
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 -
Sponsored by NTT DATA
[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 -
Sponsored by MMIT
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 -
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