Manufacturing

Finding a GMP and ISO manufacturer that supports your project with the supply of materials from pre-clinical through clinical trial phases to scale up, validation and commercial manufacturing is not easy. We provide a reliable, flexible and consistent contract services partner. Whilst sourcing high-quality supplies within trial timelines, you will need clinical trial supply manufacturing that is both fully GMP compliant and responsive, we provide all of these.

A complete solution

Full integration

Our manufacturing operations are fully integrated with our sourcing, formulation development, process development, analytical testing, quality control, quality assurance teams. As part of our service we provide full cleaning method development, GMP batch manufacturing and GMP release testing with QP release, we offer a one-source solution for supplies for use from small to large scale.

GMP release

Our Quality Control team are experienced in batch or lot release testing using a wide range of analytical technologies to provide responsive release analytics to ensure that your product is manufactured to the correct specification within the Marketing Authorisation (MA) or Clinical Trial Dossier (CTD).

Qualified facilities

We have been successfully inspected by FDA, our facility is routinely inspected by the Swedish Medicines Agency, the regulatory body within Sweden, which carries out inspections to ensure that manufacturing sites comply with GMP.

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

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.

Contact

Magle Chemoswed AB

Agneslundsvägen 27
212 15 Malmö, Sweden
info@maglechemoswed.com
+46 (0)40 38 33 00

Magle Chemoswed and Logos are registered trademarks of Magle Chemoswed.