Not too much and not too little. The secondary drying cycle in lyophilization can remove too much residual moisture and degrade the product. In fact, as Devendra Ridhurkar says, excessive drying can be as detrimental as insufficient drying. bioprocessonline.com/doc/whe…

Bridging the divide between the promises of AI and the current realities of biomanufacturing is critical to achieve the next generation of biopharma production. See what James Colley, Ph.D., a senior director of BioPhorum, has to say about it: bioprocessonline.com/doc/on-…

Will Olughu, Ph.D., came on the "Better Biopharma" podcast to discuss process modeling and AI applications in biopharma manufacturing. He explains what digital twins are (and aren't) and the challenge of implementation in GMP environments. Listen here: bioprocessonline.com/doc/imp…

USP Class VI goes away on Dec. 1. Does that mean retesting every single-use component? Of course not. Here's what you should do instead. bioprocessonline.com/doc/is-…

You check references when bringing on a new employee. What about a new CDMO? bioprocessonline.com/doc/cdm…

Tonix Pharmaceuticals' chief technical officer appeared on the "Better Biopharma" podcast to talk about the planning and construction of its purpose-built vaccine manufacturing facility. Check out the full interview wherever you get your podcasts! bioprocessonline.com/doc/bui…

Your car has more PAT than most GMP lyophilizers. @rgd_art at @PurdueEngineers lays out a roadmap to change that. ww.bioprocessonline.com/doc/…

"AI systems built on broken architecture just fail faster and more expensively," said Martin Kockx, a principal manufacturing systems engineer at Vertex. Bioprocess Online caught up with him after his presentation at BPI. See the full interview here: bioprocessonline.com/doc/con…

"An ADC cannot be optimized solely by improving its chemistry. The biology of the target antigen is equally important. However, perfect tumor-specific expression is uncommon," says Robert Dream, offering some solutions to ADCs' biggest CMC challenges. bioprocessonline.com/doc/eng…

Can residual endotoxin on 0.1% of containers trigger a 483? Sandeep Desai shared a 2019 case: cold zones at the edge of a depyrogenation tunnel left just that much behind. It was enough. bioprocessonline.com/doc/qua…

Tacit knowledge is a landmine for your MES ambitions. Manufacturing execution systems only work when processes are written down — all of them. Sri Harsha Chakrapani lays out seven decisions you need to make before setting one up. bioprocessonline.com/doc/you…

Innovation in container closure science usually feels like a slow-moving train. It's been 27 years since the FDA overhauled its guidance on the matter, finally catching up with new modalities. 🤔 That might explain why. Read @timsandle's take: bioprocessonline.com/doc/fda…

After scrubbing hundreds of CRLs for CGTs, Sidharth Ananthanarayan found a single thread connecting all of them. bioprocessonline.com/doc/com…

When a global crisis or other demand calls for rapid mobilization, process equipment designed to be modular, multipurpose, and single-use all help with rapid scale-up. By @TFFPharma #modularmanufacturing #mobilemanufacturing #vaccinemanufacturing bioprocessonline.com/doc/mod…

#BusinessOfBiotech #podcast is brought to you by @BioProcessOL in partnership with @Cytiva. Check out this week’s episode featuring @UmojaBiopharma CEO David Fontana. #SolidTumors #oncology #cartcell #biopharma #SolidTumors #InVivo #CellTherapies bioprocessonline.com/doc/in-…

There are more than 260 genes known to cause inherited retinal diseases, and @OpusGenetics’ discovery and development work are leaving none of those stones unturned. Featuring Ben Yerxa #retinaldisease #biopharma #genetherapy #venturephilanthropy bioprocessonline.com/doc/ven…

Particles in parenteral products are a major cause of product recalls, and appropriate risk management from visible particles is vital. By @Biophorum #biopharma #parenteralproducts #drugmanufacturing #injectabledrugs #biologics bioprocessonline.com/doc/a-m…

In #FDAGuidance, “#nanomedicine” refers to a drug product that contains at least one component with a dimension in the size range of approximately 1 nanometer (nm) up to 100 nm. Focus of the guidance is on a risk-based regulatory strategy. bioprocessonline.com/doc/fda…

#BusinessOfBiotech #podcast is brought to you by Bioprocess Online in partnership with @Cytiva. Check out this week’s episode featuring Nutcracker Therapeutics’ Chief Business Officer, Dr. Geoff Nosrati. #RNATherapeutics #RNA #biopharmaceutical bioprocessonline.com/doc/rna…

When a global crisis or other demand calls for rapid mobilization, process equipment designed to be modular, multipurpose, and single-use all help with rapid scale-up. By @TFFPharma #modularmanufacturing #mobilemanufacturing #vaccinemanufacturing bioprocessonline.com/doc/mod…