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Technical Transfer

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

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

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Ensure compliance with CMC regulation and GMP standards.

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Our latest blog posts


The Meeting Load Paradox

Lately I hear more and more people complaining about the burden of meetings and actually stating that meetings are the no.1 barrier to productivity.

Even worse a lot of people claim to leave a meeting without a clear idea on what to do next. The result? More follow up meetings… Adding to the frustration, many meetings are simply used to disseminate information (couldn’t it have been an email?). As a consequence, we are ending up hating them so much that they are ineffective even for social aims, like collaborating with colleagues, brain storming or decision making.

How to solve this? There are serious studies on the topic as well as more humorous ones. The reality of organizational life in contemporary organizations involves many contradictions and the meeting load paradox is one of them. People need meetings. Teams need meetings. However, there are costs associated with having more or fewer meetings. It is these costs that organizations, their leaders, and their employees need to consider. At what point does the meeting load become a burden to employees and managers rather than lift them to better heights?


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.