R5 Pharmaceuticals

Overview

R5 is the formulation development unit of Aesica Pharmaceuticals.

Aesica is a European-based contract API, pharmaceutical development, clinical trial to commercial formulated product and analytical company established by experienced ex-Industry scientists in 2004. We offer an innovative and essential service to biotechnology and pharmaceutical clients providing API, formulation and process development expertise and clinical trial manufacture, final product commercial manufacture and packaging.

The Company prides itself on developing the best formulation and approach to administering a clients' therapy, which will depend on the drugs physical and chemical characteristics and the patient group being treated. Dosage forms developed include: Oral (e.g. tablet, capsule, liquid) , Topical (e.g. cream, ointment, nasal), Inhaled(DPI, MDI, nebuliser, nasal) & Injectables.

We also have in-depth experience of product extension approaches, re-formulating marketed products into alternative dosage forms. Key to all projects is analysis and we have a highly experienced analytical team, with full analytical capabilities to support any project. R5 compliments its development resource with a GMP clinical trials supply manufacturing service at our UK MHRA-approved facility for both sterile and non-sterile preparations. We are very proud to have our own Qualified Personnel to release the therapies into the clinic. Our team is also very used to establishing relevant manufacturing processes and conducting technical transfers to other sites for later stage clinical trial and commercial manufacture. We embrace & have available newer technologies such as nanomilling, spraying-drying and Pneumatic Dry Granulation techniques.

Standards & Methodologies

Reverse Engineering, HPLC, Sterile & non-Sterile manufacture, Stability testing, QP-release

Qualifications, Certifications, Accreditations & Licenses

Pharmaceuticals - GMP, MHRA-accredited for the manufacture & testing of IMPs & commercial manufacture (inc cytotoxics). FDA-approved sites for API and Final Product manufacture. JMHLW approved site. Other geographical authorities approved as well. Food - UKAS