Bioprocess Online Live, Nov. 17, explores the current and future state of predictive control in biopharmaceutical manufacturing.

Register for free.

Sign up today: event.on24.com/wcc/r/5512381/…

Closing The CAR-T Access Gap With Hospital-Based Manufacturing - @BoroDropulic, @caring_cross/VectorBioMed for @_CellandGene

cellandgene.com/doc/closing-th…

Flawed individual AI outputs might seem plausible until you trend them. The latest Annex 22 draft aims to rein in the gap between single items and the whole process.

Sachin Bhandari at TrustBridge Compliance breaks it down. bioprocessonline.com/doc/what-europ…

Big bang: a complex system change or upgrade that happens all at once with no option to rollback.

@Roche leaders explained one such cutover involving three integrated systems at a fill/finish site in Kaiseraugst.

bioprocessonline.com/doc/how-to-kee…

Clonal cell line selection can take weeks (or longer), and that's why people like Susan Sharfstein, Ph.D., are devising ways to accelerate the process.

Watch the full interview with Sharfstein at Bioprocess Online or wherever you get your podcasts:
bioprocessonline.com/doc/streamlini…

Distance makes a quantifiable difference that POC manufacturing can solve, writes Boro Dropulić. For people in poverty living 50 miles-plus from academic medical centers, "each additional 10 miles lowers their likelihood of getting CAR-T therapy by 6%."

As the cost of labor and materials falls, Dropulić makes the case that distributed manufacturing has never been more in reach. bioprocessonline.com/doc/closing-th…

FDA's on-again-off-again policy for CRL release indicates "a general lack of clarity about what the FDA’s campaign for 'radical transparency' should look like in practice," writes @joshcmorrison of @1daysooner.

bioprocessonline.com/doc/an-incompl…

Futuristic vision or imminent reality? On Nov. 17, panelists from Sanofi, Octapharma, and PQE Group will discuss what it takes to move from automation to predictive control — and how soon we might see truly autonomous manufacturing.

Register for free: event.on24.com/wcc/r/5512381/…

War in the Gulf, tariffs up to 100%, and attacks on clinical trial data have a direct effect on most analytical disciplines but to varying degrees. Here's how one analyst describes the impact of global disruption on analytics.

Read the rest: bioprocessonline.com/doc/navigating…

The higher the DAR, the better, right? Not so fast. When developing ADCs, high DAR doesn't always mean a better drug. As Robert Dream explains, more payload can lead to problems like hydrophobicity and aggregation.

bioprocessonline.com/doc/engineerin…

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/when-lyoph…

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-the-gro…

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/implementi…

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-your-su…

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

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/building-a…

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

"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/contextual…