Drug development and upscaling

The development of a new medicinal product and the transfer from development laboratory scale to industrial production scale is a complex challenge - and a great opportunity to define processes from the outset that meet GMP requirements as well as lean principles for efficient and cost-optimized production. We support you in the planning of your own production facilities for your new products as well as in the transfer to your existing industrial production facility or to a contract manufacturer, if required also in the patent-free area.

Ideally, the transfer to industrial production and thus upscaling is already considered in drug development projects - for example by us. We work with your development team to develop the finished product characteristics and manufacturing processes that form the technical basis for industrial production.

We are also happy to plan options for further scalability of production capacities in the sense of proactive lifecycle management in order to be able to flexibly increase or decrease production volumes.

Launch volume production

The first market launch places extreme demands on the pharmaceutical manufacturer. This applies in particular to patent-protected medicinal products that are launched on day 1 after patent expiry, but also to medicinal products that have special features in the type of packaging, as these should be taken into account at an early stage during the selection and establishment of the manufacturing site.

If the first delivery has to be made to many pharmacies and wholesalers at the same time, extraordinary production quantities are necessary, which also require a full release analysis and certification by a Qualified Person in accordance with Annex 16 of the EU GMP guidelines for production in off-patent countries outside the EU. This requires careful planning and, above all, reliable supply chains in the pre-launch phase. Thanks to our many years of expertise, we are familiar with the challenges of launch volume production and ensure that your product reaches the market reliably, safely and on time with carefully coordinated planning, technical production knowledge and the willingness to be on site at the manufacturing plant.

We assist with drug development:

Technical production facility design

Our customized, practice-oriented production concepts support the development of lean and GMP-compliant production processes.
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Troubleshooting

As pharmaceutical technologists with extensive production experience, we solve technical production challenges professionally and efficiently.
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Production transfer

We provide support in the strategic planning and technical implementation of product transfers and calculate the expected financial effects.
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Do you have any questions about the products and services of Bensmann GmbH?

Please feel free to contact us:

Phone     +49 151 2398 1568
e-mail       info@bensmanngmbh.de
or via  Contact form