Manufacturing
Finding an API manufacturer that wants to grow with you from Pre-Clinical, through Phase I, II and II studies and to scale up to commercial manufacturing is not easy. You need to feel confidence and support throughout the way. We can supply both cGMP and non-GMP material to support your needs and pride ourselves in on time delivery and consistency.
Pre-clinical
API for early use is produced at state-of-the-art manufacturing facilities. We can supply both cGMP and non-GMP material to support your needs. A team of experts will surround your project with a full range of technologies. The supply of materials is fully supported by analytical services and we pride ourselves for on time delivery.
Clinical materials
API for early and late-stage trials will be manufactured at our cGMP commercial production facility that supports a wide range of scales that are available to meet your needs and keep your costs in line. Our team of experts will work continuously to optimize processes, increase outputs and reduce timelines.
Manufacturing capabilities
- 4 multipurpose units operating in 2 shift
- Reactor volumes from 200 to 10 000 L, glass lined and stainless steel
- Production of batch sizes from 1 to 500 kg
- Separate dryers in classified areas
- Lab scale production of batch sizes from mg to kg scale
- Contained production capabilities for highly potent material
- USP purified water system
- Temperature Range -100 ˚C to +175 ˚C
- Pressure up to 30 bars
Scale up
Scale up will include risk assessment and proven acceptable range studies, as well as validation of analytical methods and the manufacturing process. Our QA/ regulatory and validation compliance team will provide data and support for the CMC portion of your submission. All our facilities comply with cGMP regulations and are regularly inspected by national regulatory agencies.
Validation and supply
As part of the establishment of your commercial supply of API, Magle Chemoswed provides a complete validation package according to regulatory and cGMP guidelines. We have a highly successful and established program to ensure you’ll have everything you need to secure reliability of your supply with consistently high quality.
Talk to one of our specialists
Hans Uvelius
Hans has been with the Magle Chemoswed organization since 1978 and has held numerous positions in both production and research and development. He is currently our Development Manufacturing Manager.
