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Technical Transfer

Tech transfer and programme management are our specialty. We can help with your most challenging projects.

Scientific Writing

Offer support for the preparation of CMC-related documentation required for submission (US and Europe).

GMP Compliance

Ensure compliance with CMC regulation and GMP standards.

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Our latest blog posts


Single Use or Stainless Steel?

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.


Can you Manage 4 Nationalities in a Room?

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.