Contract development and manufacturing
Helping you to meet your challenges
Specialists in manufacturing semi-solids and liquids
The Bioglan facility allows us to produce clinical trial batches (phase I, II and III) as well as commercial scale batches for world-wide sales. The facility operates under GMP and is regularly inspected by the Swedish Medical Products Agency, a process that assures acceptance by all European authorities. The quality system fulfills the EU GMP (Good Manufacturing Practices) requirements as well as the ISO 13485 standard for Medical Devices.
Our manufacturing authorization allows us to produce non-sterile semi-solid and liquid products, including clinical trial material. Manufacturing in batches from small scale (< 1 kg) to 1250 kg can be offered, and products can be filled into tubes, bottles and jars.
Also, non-GMP research and development materials can be manufactured in the laboratory part of the facility for use in early stability or validation studies and for pre-clinical trial studies.
We will optimize your formulation, while always keeping your development program in mind. Seamless scale-up, continuous method and process development, and validation performed by the same team who designed the formulation will assure the quality of your product and reduce costs and shorten the development time.
Manufacturing for safety and efficacy studies
Bioglan has experience in the production of clinical trial materials for all stages of your clinical development. Our special pilot plant allows us to produce small scale clinical trial batches for the initial trials, while our main facility allows us to produce commercial scale batches often needed in the later pivotal trials. We can also assist you in labelling, packaging, QP release and distribution of the clinical trial material.
Clinical trial manufacturing and packaging services include:
- Adherence to EU and other market standards
- Manufacturing of phase I, II, III & registration batches
- Full CTM formulation, manufacturing, labelling, packaging and release testing
- CMC (clinical manufacturing) support documentation
- IND (Investigational New Drug Application)
- IMPD (Investigational Medicinal Product Dossier)
- Full quality support for all clinical materials
It is time to reach the market
The team that supports you in product development has extensive understanding of the commercial manufacturing processes. Seamless scale-up, continuous method and process development and validation will assure the quality of your product and reduce cost and shorten the development time.
The development team will assist you in:
- Process development for pilot and commercial scale manufacturing
- Manufacturing process optimization and validation
- Cleaning validation
- Clinical material manufacturing
- Scale-up manufacturing
- Process transfer and adaptation – site transfers – if required