Rechon Life Science Pharmaceutical Product Development and Commercial Manufacturing
Rechon Life Science provides services for pharmaceutical, biotech and life science companies in the development and manufacturing of pharmaceutical products such as aseptic vials, ampoules and syringes, and oral and nasal products.
Non-sterile, sterile and aseptic liquid manufacture
Rechon is a manufacturer of non-sterile, sterile and aseptic liquids, from small-scale for clinical trials up to full-scale to supply commercial markets worldwide. We can also assist with QP releases for other types of products and support your regulatory filings.
Rechon’s dedicated, creative and customer-focused team delivers projects on time with the right quality in a cost-effective way. We are proud to be a supplier of services to all global markets including the US, Japan and Europe.
Small volume parenterals, and oral and nasal liquid products
Rechon has a long experience in the development and manufacturing of pharmaceuticals, with more than 50 years’ history as Ferring. Our extensive experience, competence and technical resources allow us to offer you any service you require within the field of small volume parenterals, and oral and nasal liquid products.
Our facility allows us to produce clinical as well as commercial-scale batches for global supply. The facility operates under cGMP and is regularly inspected by the Swedish Medical Products Agency, US FDA and other health authorities.
Contract pharmaceutical services
Rechon focuses on contract pharmaceutical services and collaborates with companies of all sizes, from the smallest start-up to the leading pharmaceutical industries.
We can provide a comprehensive set of services throughout the development process. Our team will work with you to define the best solution for all project phases. We assemble project teams with experts in all areas.
Commercial-scale and small-scale batches for development and clinical trials
In our cGMP facility in Limhamn we produce not only commercial-scale batches but also small-scale batches for development and clinical trials. Our specialities are aseptic filling of ampoules, vials and pre-filled syringes, and filling of nasal/oral spray including final packaging.
Our services include:
- Non-GMP early development material in separate facilities
- Manufacturing of clinical trial material
- Manufacturing and filling of finished products
- Packaging of finished products
Our compounding and filling capabilities allow batch sizes from 1l to 1,200l, valuable in all steps in the process, from the first clinical batch to the final commercial batch size. The filling lines include rinsing machines, sterilisation tunnels, and filling and sealing of injectables and spray products.
In the packaging area Rechon uses medium/high-speed lines equipped with vision systems and bar code readers for labelling control and check weighing systems for the final control.
Our project team will assist you in all process development and scale-up activities, including validation of each manufacturing step.
Clinical trial materials and clinical service
Rechon has experience in the manufacturing of clinical trial materials for all stages of clinical development. Our services include:
- Clinical manufacturing, phase I, II, III and IV
- Import of clinical trial supplies
- Labelling, packaging, blinding and distribution to clinical sites worldwide
- QP and ‘Green card’ release
- Regulatory support documentation (CMC/Module 3)
- IND and IMPD documentation
Rechon can manage the entire clinical supply chain, from manufacture and transport to clinics, to returns and destruction.
Supplier audits, product quality reviews, QP release and other regulatory services
Rechon can assist you with audits of suppliers, product quality reviews, QP release, product complaints and other quality and regulatory services.
We can also provide a high-quality analytical service, with skilled and experienced staff and well-equipped laboratories. Our chemical and microbiology control laboratories’ services include:
- Method development
- Method validation
- Stability studies
- Testing of products and starting materials
- Testing of WFI, purified water and media supply
- Environmental monitoring
Rechon can provide a full chain of quality services or assist in specific areas based on your needs.