Reliable partner for contract manufacturing
JEmedis as CDMO
JEmedis supports you with all its expertise. Also and above all as a reliable partner in the CDMO sector. As a contract manufacturer, we are the right partner for you: from process development to the finished product in the R&D area and pilot scale.
CDMO
A Contract Development and Manufacturing Organization (CDMO) is a company that provides other companies with comprehensive services ranging from drug development to drug manufacturing. Pharmaceutical and biotechnology companies use CDMOs to reduce fixed costs, simplify supply chains and shorten R&D lead times.
JEmedis is the ideal partner
This is where we come in as a new player. JEmedis is able to collaborate on process development in the early stages and produce pilot-scale batches. In doing so, we bring We apply our expertise in innovative product development to our customers’ projects and offer them customized processes. This enables us to support you in optimizing and accelerating production steps and reducing risks.
We look forward to the challenges of the future and are always available to our customers with help and advice.
Biologics:
Process development, contract manufacturing and analytics
Would you like to have your product manufactured on an R&D laboratory scale or reorganize and optimize your manufacturing process?
Then you’ve come to the right place. We support our customers in the development, implementation and optimization of their manufacturing process with the aim of producing a safe product with consistent quality. We have specialized in single-use systems.
Your manufacturing process has already been determined and you would like to have your drug produced on a pilot scale for testing purposes or for preclinical or clinical studies?
Then we are the right partner for you. In our modern GMP cleanroom facility, we offer our customers aseptic fill & finish service for their product in small batches on request, including approval by our qualified person.
Our services at a glance:
In our modern cleanroom facility (RK D to B(A)), we offer support in the development and optimization of manufacturing processes for biologics based on an existing manufacturing design as well as contract manufacturing of pilot batches (cGMP and non-GMP), among other things:
Upstream & Downstream
- Microbiological cultivation and fermentation of bacteria including risk group 2
- Production in state of the art cleanrooms
- Development of transfer lines for aseptic transfer
- Filtration & formulation
- Scale up from laboratory scale to pilot scale
Aseptic Fill & Finish
- Semi-automatic aseptic filling from 0.5 to 50 ml filling volume using various vial sizes
- Integrated freeze-drying in the A area with 1.05 square meters of floor space and a capacity of 4000 2 R vials or 1000 20 R vials per batch
- Semi-automatic crimping of 13 mm and 20 mm closures
- Labeling of vials (for investigational medicinal products)
Analytics
We work together with our reliable and GMP-certified partner laboratory for quality control and analytical testing of the products/medicinal products. Tests can be carried out in the areas of microbiology, analytics and molecular biology, which are approved by our Head of Quality Control.
Support & advice
Thanks to our experience in this area and close cooperation with our suppliers and service providers, we can support you in the selection of suitable SU equipment, primary packaging and the like.