Archives October 2024

Single-use (SU) technologies increasingly find use today at all phases of the drug development cycle from preclinical to commercial manufacturing.

As the biopharmaceutical market continues to expand and reliance of SU manufacturing rises, demand for SU consumables (i.e. bags, containers, filters etc) is also increasing. A key driver for that growth is the fact that SU consumables come pre-sterilized and ready-to-use, making step and changeover from one product to another much quicker and easier. Single-use systems enhance flexibility, scalability and efficiency. Single-use facilities boast the benefits of shorter facility development and deployment timeframes.

However stainless steel is expected to remain in use for some time. Stainless steel retains its relevance for certain products. Universal block-buster, such as treatments for cancer, diabetes and others in which large volume is required, will keep on being produced in stainless steel. Stainless steel bioreactors can support manufacturers across a variety of higher volumes, including those between 10.000 and 20.000 L. Though stainless steel has a higher upfront costs, if you have a blockbuster drug, it could provide more long terms savings because of its durability.

Is there a best choice then? Choice is totally dependent on each biomanufacturer’s unique scenario. Factors to consider can include molecule type, cell density, demand stage (pre-clinical, early phase, late-phase, clinical, commercial etc), patient population, quantity of product,, single-product versus multi-product facility and new versus existing facility. All these together (and more) will help make a best choice from both an economical and environmental perspective.

In conclusion, a comprehensive evaluation always has to be made at design onset.

Put a French, a Dutch, an American and an Indian in the same room. Ask them to work together. What do you get? No, this is not the beginning of a funny joke! Tt is a typical example of a work reality in the pharmaceutical world and of the importance of navigating cultural differences.

Globalization has transformed the way we work: our companies are becoming more and more international. Cooperation with third parties a normality. As a consequence, cross cultural communication is something we deal with on daily basis. A new and softer side of negotiation is therefore needed. Sometimes cultures do not translate and we frequently split into separate camps that have an ‘us versus them’ reality.

After performing so many different tech transfers and having witnessed so many audits, I came to the conclusion that getting culture right should never be an afterthought. Even if English is the common language, it is easy to fall into cultural traps that endanger a project or a a cooperation.

Diversity: the art of thinking independently together

Malcolm Forbes

If you really have a French, a Dutch, an American and an Indian, how will they be able to work harmoniously together?

The Indian manager learns never to criticize a colleague openly in front of others, while Dutch managers learn always to be honest and to give the message straight! Americans are trained to wrap positive messages around negative ones, while the French are trained to criticize passionately and provide positive feedback sparingly. Having a clear understanding of these differences and strategies for navigating them is crucial for leaders of cross-cultural teams. How to reach that understanding? There are many courses you can follow, but also books you can read.

People in different countries reach to inputs differently, communicate differently and take decisions differently. When you look at your team’s culture map, consider not just the difficulties that might arise from the gaps but also the strengths that those differences may provide. Managed with care, the cultural and individual diversity can become your team’s greatest asset!!

Don’t forget to think carefully about your objectives before mixing cultures up. If your goal is innovation and creativity, the more cultural diversity the better, as long as the process is managed carefully. But if your goal is simple speed and efficiency, then monocultural is probably better than multicultural. Sometimes, it is simply better to leave Rome to the Romans.

I hear many people (including myself) talk about how they want to make a difference at work or in general in the world. I believe most of us are genuine when we make this statement. However, wanting to make a difference and making a difference  are completely “different” things.

We now have scientific proof that, the more we care about the happiness and wellbeing of our fellow humans, the happier we get. One pleasant side effect of making that kind of a difference is that, by changing the world around us, we change ourselves. And vice-versa. It is a “virtuous cycle.” 

People who really want to make a difference in the world usually do it, in one way or another. And I’ve noticed something about people who make a difference in the world: they hold the unshakable conviction that individuals are extremely important, that every life matters. They get excited over one smile. They are willing to feed one stomach, educate one mind, and treat one wound. They aren’t determined to revolutionize the world all at once; they’re satisfied with small changes. Over time, though, the small changes add up. Sometimes they even transform cities and nations, and yes, the world.

Beth Clark from ‘Kisses from Katie’

This year I had the privilege of meeting someone who really wants to make a difference and is actually making it! Despite being an extremely busy professional, from February on, she regularly cleared a bit of her schedule to coach on a volunteering basis a boy based in a remote fishermen village in Malawi. From what I hear, the time she dedicated to him, the advices and guidance she provided are something which did not go unnoticed and will not be forgotten. To use Ramos’s (the boy) words ‘Marcelle is an exceptional coach who has made a profound impact on my life and business. She offered me guidance, support and expertise. Her dedication, wisdom, compassionate mentorship and enthusiasm have been invaluable and I feel really lucky to have her in my corner’.

Looking forward to meeting more committed professionals like Marcelle in the future!

Whether you are given advance notice as part of an international inspection or have the FDA knocking on the door unannounced, it pays to prepare. Inspection readiness is essential! This preparation is a combination of awareness of what the inspector is looking for, understanding the history of your product and where potential issues lie, and evidence to demonstrate that you are working towards correcting those potential issues.

The “FDA Compliance Program Manual for Pre-Approval Inspections” provides a framework for the FDA Pre-Approval Inspection Program, the overall process, and instructions on how the FDA executes the Program. However, despite the amount of information available for a correct preparation, getting inspection ready always requires an extensive effort. Moreover, some companies are still struggling to become fully compliant to the requirement of the updated Annex 1.

Recently I was asked by Nanomi to help them prepare for an FDA PAI at their CMO. The company had submitted a long-lasting injectable and was therefore notified by the FDA about the incoming inspection. It was time to get inspection ready.

Begin with the end in mind

Steven Covey

Controlling the flow of information and people are key to a successful inspection and should be a major part of your ‘game plan’. The first tip is on setting up the inspection space and establishing roles and responsibilities for the host team. This involves having a front room and back room with team members assigned to each room who understand exactly what they are responsible for.

The above is something most companies have under control. The importance of mock audits and training of personnel is also normally well understood.

When preparing for an audit however I often see firms struggling with documentation. Reports are not stored properly, protocols history is not well documented, development report doesn’t tell a story. Sometimes you don’t even have reports or documents on technology transfer. All this documentation is part of the information that creates the foundation to support the product through its lifecycle. Understanding the process can at times really be more (or equally) important than the end product!

Some time ago I came across the below CMC maturity model. Copying it here since I believe it summarizes in the best way what a company should aim for: level 4 or 5.

With Nanomi the outcome of the FDA PAI was a successful one. It was a great pleasure to cooperate with people from literally all over the world to make that happen.

Until next one….