Gene and Eva’s (mis)adventures in the Trials of a medicine maker

We’ve all been there…finding everyday bioprocessing a bit more challenging than we imagined when we woke up that morning.For Gene and Eva, in the cartoon series Trials of a medicine maker, this is certainly a reality.

Extractables and leachables: clearing the alphabet soup

Oh dear, Gene had better get his extractables and leachables (E&L) act together now that Eva is leaving. The right E&L support can help ensure product safety and accelerate regulatory submission. So, let’s hope the alphabet soup clears up in the end.

Lost in the process characterization matrix? QbD will guide you.

Whoa…that virtual reality tour Eva set up is certainly impressive! When you’re seeking process understanding and raw material insights, it might feel like you’re diving into the Matrix. But a quality by design (QbD) approach and a solid control strategy will help bring order to the chaos.

Gene therapy scale up…or did someone say scale out?

Quick, someone please put a stop to that “Gene” therapy! Eva seems to be on a better track when it comes to ideas for scaling up cell and gene therapy manufacturing. Let’s hope Gene gets the picture and gives up his scale-out plan.

Mechanistic modeling: going small is the big idea

Small-scale models aren’t just for toy trains anymore! OK, so Gene probably won’t need his glue. But mechanistic modeling and miniaturized formats in high-throughput process development is still exciting stuff in the world of bioprocessing.

Raw material e-data: a recipe for biomanufacturing success?

Raw material variability can sometimes cause problems in biomanufacturing. Gene has found a new way to stay on top of raw material variations, but his reward was somewhat unexpected…

If you fail to prepare…prepare to fail

Keeping up with your preventive maintenance routine is crucial to avoid revenue loss due to unexpected downtime. In this month’s cartoon, medicine makers Gene and Eva feel like they have it all figured out. But how prepared are they really?

Viral vectors: restless and demanding?

Manufacturing viral vectors, like many unchartered areas, can seem stressful compared to other biologics. But Gene finds out that there are easy ways to meet the challenges and live in peace with even the most demanding vector.

Can digital switch off the biopharma manufacturing lights?

Hey! Who turned the light out?! Gene and Eva may be wandering in the dark…but not aimlessly. Their achievement of lights out manufacturing in biopharma may seem futuristic, but by integrating digital we can get closer to this reality than we think.

Talent crunch in bioprocessing, lock up your staff…

The bioprocessing talent pool seems to be draining faster than it’s filling up. As always, Gene thinks he has everything under control. But there are better ways to keep skilled staff than keeping them locked up, such as hands-on training in bioprocess techniques.

Tired of watching cells grow? Try process intensification

Gene would much rather be riding the fast train and surfing the waves, but sadly he’s stuck on the slow train. Inoculum train expansion can be exhausting. Help is on its way though, in the shape of process intensification.

Cell therapy: new beginnings, old challenges?

There’s a new Gene in cell and gene therapy…and he is not too thrilled about it. He should be though! Join our medicine makers as they dive into the exciting world of stem cells, CAR T-cells, regenerative medicine, and more.

Raw material, risk, and rough interrogations

Aha! No wonder Gene and Eva got variability in their results. Mice living in the cell culture ingredients just don’t make for great bioprocessing results. An open communication between Gene and Eva and their supplier could sure improve their raw material and risk management. Perhaps they should go digital?

DoE or DOA…don’t leave your outcome to chance

A little more help from Gene would go a long way. Eva seems to know the basics of design of experiments (DoE). But Gene’s project management skills are certainly in question, especially as it’s Eva who is taking the heat.

Don’t get bitten by the bioburden bug

Bioburden is the stuff nightmares are made of. No wonder Eva can’t sleep. The last thing she wants is a bioburden control issue in her bioprocessing facility. Just as any biomanufacturer, her priority is to make every product safe and effective for patients.

Tech transfer: smooth sailing?

It must have been one hungry dog Gene’s got. Hopefully Gene managed to pull together the hard copies in the end. There’s plenty to consider in tech transfer. But there are also great resources available, like training courses for bioprocess scale-up and tech transfer.

Chromatography: column packing for dummies?

Captain Column sure looks a bit discouraged…No wonder when his first mission was completed by a shiny new automatic chromatography column! But Eva was right to send Gene on a column packing training course. Manual packing is a time-consuming art.

Overcoming the bioprocess buffer bottleneck

Eva wishes she was on vacation, but she knows her team would struggle with buffer management without her. As biomanufacturing titers go up, so do downstream buffer volumes, but there are clever solutions available for buffer management.

Continuous bioprocessing: smart or scary?

Great that Gene and Eva didn’t give up on trying to get the benefits of continuous biomanufacturing across. Because there are many. Take greater flexibility for example, or smaller facilities with less utilities, less staff, and less cost.

Security of supply: make a supplier’s weakness your strength

Oh yes, Gene should just trust Eva on this one. No one wants to gamble on the safety, efficiency, or availability of a biopharmaceutical. A tip is to keep an eye out for suppliers with a structured, risk-based approach to security of supply.

Collaborative PD outsourcing: why closer is better

Sharing process details externally might seem too close for comfort. But when it comes to process development outsourcing, a close collaboration can actually bring added benefits.

The next best thing to predicting the future

Wouldn’t it be great to be able to see into the future? That way you could decide your biomanufacturing strategy early on. As we continue to dream about this unlikely scenario, let’s join Gene and Eva as they look at the next best thing— single-use technologies.

The secret to PAT's (kitchen) success

Comparing kitchens to cleanrooms might seem strange. But, as medicine makers Gene and Eva discovered, process analytical technologies (PAT) can bring success in both places. Here’s why.