Purna Drug Delivery Systems and Clinical Development Services
Purna is an independent Belgian contract development and manufacturing organisation (CDMO) specialised in customised drug development services and manufacturing of semi-solid and liquid dosage forms.
Purna offers expertise in all aspects of the development and manufacture and can take your products from early development to commercial manufacturing. It successfully serves small start-ups and large pharmaceutical companies.
Purna offers a variety of development services, including active pharmaceutical ingredient (API) characterisation, analytical development, drug method optimisation, re-formulation, equivalence studies, packing and labelling.
Analytical and formulation development for drug medication
Purna has a comprehensive range of services to help scale pharmaceutical, medical device and cosmetic products, from early concept design to commercial manufacturing.
The company’s project managers ensure that clients’ timelines are met and final forms adhere to regulatory requirements such as the Food and Drug Administration (FDA) and good manufacturing practice (GMP). This optimises time-to-market and avoids transfer expenditure, as all processes are performed from one site.
Purna’s analytical laboratory is compliant with good laboratory practice (GLP) guidelines. It offers degradation and stability studies, microbiological evaluation and dissolution testing, as well as API characterisation to identify particle size distribution, polymorphism, residential solvents and densitometry. Gas chromatography (GC), high-performance liquid chromatography (HPLC) and ultra-HPLC (UHPLC) methods are also available to test assay stability.
The company is a flexible partner for formulation development, offering three decades of experience in processing solutions, emulsions, suspensions, lotions, gels, pastes and creams. It performs re-formulation and reverse engineering, optimisation of API characteristics and locating reference drug products following a design of experiments (DoE) and quality by design (QbD) approach.
Purna is licensed to produce small-scale batches for both pre-clinical studies and Phase I-III clinical trials.
Commercial contract manufacturing of pharmaceutical products
Purna uses original equipment effectiveness (OEE) techniques to manufacture a wide array of medicines in various batch sizes. Its state-of-the-art facilities ensure highly efficient production to deliver products according to client deadlines. Its high-quality equipment helps reduce manufacturing costs.
The company delivers its service in line with clients’ processing procedures, handling both web-integrated and electronic data interchange (EDI) orders. In addition, quality management and shipping procedures can be adjusted.
Purna offers liquid product manufacturing in sizes ranging from 150l to 10,000l. Solutions, suspensions and emulsions are filled into plastic or glass bottles, cans, intermediate bulk containers (IBC), aerosols and sachets.
Semi-solids such as creams, ointments, pastes and gels are produced in 20l-2,000l batches. Upscaling is achieved using temperature-controlled production in homogenisers. The semi-solids are packaged into tubes, jars, buckets or sachets.
Out-licensing platform for novel medical technologies
Purna is a preferred partner for many top-ten pharmaceutical multinationals. Its established out-licensing platform helps drug developers with innovative technologies optimise value.
The company also exports over-the-counter (OTC) own-label products to non-governmental organisations (NGO) and international authorities. It offers a wide range of high-quality and cost-effective products to people in need.
Products and Services