March 9th 2025
Exosomes, polymeric nanoparticles, and DNA nanostructures offer many potential advantages.
February 25th 2025
The value of outsourcing partnerships for next-gen biotherapeutics rests in the expertise and technologies that service providers bring to the table.
February 13th 2025
This site was previously the beneficiary of a €7.3 million (US$7.6 million) investment, made in 2022, earmarked for the production of HPAPIs to treat cancer.
February 12th 2025
Christian Morello, vice president and head of the Bioconjugates Business Unit at Lonza, looks at what is involved in developing modern ADCs.
February 7th 2025
Increasing API and formulation complexity and new delivery strategies are driving innovations in taste-masking.
Sanofi to Invest Roughly $430 Million in Canadian Vaccine Facility
The new facility, to be built in Toronto, Canada, will significantly increase capacity for pediatric and booster vaccines.
Amgen to Build Next-Generation Biomanufacturing Plant
The biopharmaceutical firm has chosen Rhode Island as the site of its next-generation biomanufacturing plant, which will offer flexibility, speed, and efficiency.
Lonza Opens Dedicated Cell and Gene Therapy Manufacturing Facility
The new 300,000-square-foot facility is considered the largest dedicated cell and gene therapy manufacturing facility with fully integrated services.
Roche Acquires Regenerative Medicines Program
Roche has acquired a program to develop regenerative therapies for multiple sclerosis.
Lilly, Sigilon Partner on Encapsulated Cell Therapies for Diabetes
Under this global collaboration, the companies will develop encapsulated cell therapies for treating Type 1 diabetes.
FDA Issues CRLs to Celltrion for Two Biosimilars
Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.
Boehringer Ingelheim and OSE in Immuno-Oncology Deal Worth $1.7 Billion
Boehringer Ingelheim and OSE Immunotherapeutics have entered a global immuno-oncology partnership to develop a checkpoint inhibitor for treating advanced solid tumors.
Reig Jofre and Leanbio Form Joint Venture to Develop Biosimilars
The companies have created Syna Therapeutics, a joint venture that will develop biosimilars and new molecules.
Mylan and Biocon Get Approvals for Biosimilar Insulin Glargine in Europe and Australia
The European approval marks the first approval for a biosimilar in that region resulting from the companies’ joint portfolio.
Fujifilm Expands Bioprocessing Scope
Fujifilm acquires cell culture media companies Irvine Scientific Sales Company and IS Japan.
FDA Grants Priority Review to AstraZeneca’s Leukemia Biologic
The agency has accepted AstraZeneca’s biologics license application for an investigational leukemia drug candidate and granted it priority review.
Pfizer Transfers CAR-T Assets to Allogene
Pfizer transfers CAR-T assets to Allogene Therapeutics under a new alliance to further develop immuno-oncology therapeutics.
Optimizing Particle Engineering Methods for Inhalation Drug Products
Particle engineering using jet milling or spray drying can be used to obtain appropriate particle characteristics for inhalation drug products.
Multiple Views Deliver Complete Characterization of Protein Particles
Access to multiple analytical techniques is essential for fully characterizing complex protein formulations.
Unlocking the Best Solution for API Sourcing
CMOs/CDMOs that are easy to work with, have demonstrated performance track records, and plan for the future are preferred.
Celgene, bluebird bio Partner on CAR-T Therapy
The companies will co-develop and co-promote a CAR T cell therapy in the United States.
Novartis Gets Positive EMA Opinion on Biosimilar to J&J’s Remicade
Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.
Amgen, Allergan Score Positive EMA Opinion on Biosimilar to Roche’s Herceptin
EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).
bioLIVE to Launch Global Biopharma Country Ranking
Major countries will be ranked based on the potential for biopharma market growth, innovation, and competitiveness.
Hitachi to Manufacture Regenerative Medicines
Hitachi will manufacture regenerative medicines developed by Daiichi Sankyo and SanBio Group.
Cesca Licenses CAR-T Cellular Processing Services to China’s Boyalife Group
The agreement gives IncoCell Tianjin, a wholly-owned subsidiary of China-based Boyalife Group, access to Cesca’s celluar processing contract development and manufacturing services.
Helix BioPharma Partners with ProMab on CAR-T Therapies
The collaboration between the two companies aims to finish all necessary work needed to file for a first-in-human study by early 2019.
Wuxi Biologics to Install Large-Scale Single-Use Bioreactor
The company plans to install 4000-L disposable bioreactors from ABEC at its new commercial manufacturing facility in Wuxi city, China.
Ambr 250 High Throughput Bioreactor System Speeds Up Intensified Cell Culture Process Development
Sartorius Stedim Biotech has launched a new automated parallel bioreactor system for perfusion culture.
FDA's Gottlieb Hits Innovators, Insurers for Blocking Biosimilar Uptake
The FDA commissioner outlined the agency's initiatives to reward innovation and biosimilars development.
GlobalData Reports Need to Shift to Newer Vaccine Manufacturing Technologies
GlobalData reports the need to shift away from egg-based manufacturing of vaccines in light of influenza-related deaths.
ProBioGen and Surface Oncology Sign Second Antibody Manufacturing Program
Under this agreement, the companies will develop in parallel an antibody drug candidate and cell lines for other potential candidates.
Hovione Sells its iMAX Business
In selling its contrast media business, Hovione will focus on API and drug product development and manufacturing.
AstraZeneca to Create Independent Biotech Spin-Off
The pharma major will spin out six molecules in early stage inflammation and autoimmune programs into a new company called Viela Bio.
A New Method for Risk Assessment of Pharmaceutical Excipients
This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.