Cobra Biologics, A Charles River Company

Founded in 2013, Cellin Technologies OÜ pioneered the regenerative medicine arena in Estonia by specializing in analysis, design and production of cell therapy products.

Cellin’s scientific foundation is a set of tools and methods that allow to develop a deep understanding between the stems cells and their biological function and the manufacturing process.

Cerbios is a swiss privately held company specialized in the development and manufacturing of chemical and biological APIs for its world-wide partners.

The exclusive R&D and manufacturing expertise is available to our Pharma partners needing to develop and scale-up NCE or NBE for clinical trials, registration and commercial purpose.

cGMP APIs made by Cerbios in its FDA inspected site in Switzerland are sold worldwide mainly to pharma companies including EU, USA and Japan.

Cerbios is specialized in Reduced Folates (world leader position) but also in the manufacturing of High Potency Active Ingredients (HPAPIs) with a series of Vitamin D derivatives requiring sophisticated production units with high containment levels.

Another core business is the research, development and production of Probiotics of Pharma quality.
On top of that, in the last 17 years, CERBIOS has acquired a vast experience with Recombinant Proteins from mammalian cells (CHO) based on a state-of-the-art platform.

Service for third parties in exclusive manufacturing is concentrated in the area of HPAPI and Recombinant Proteins.

Full CMC support is given to our customers in order to provide them with the supply of cGMP clinical batches, registration/validation material and commercial manufacturing. Paramount to that is the supply of all documentation required for a successful registration.

ChromaCon AG is a private Swiss Life Science tool company, developing and commercializing proprietary chromatographic process technology.

Our vision is to transform bioprocessing to continuous and our mission is to provide best-in-class tools consisting of equipment, reagents and discovery technologies to help our customers to create, develop and manufacture next-generation chemical and biological medicines.

We facilitate the conversion from batch to more efficient continuous processes by offering equipment, processes and software designed to ease the conversion from batch to continuous chromatography.

We are unique in providing laboratory-scale FPLC and HPLC equipment for the purification of proteins and small molecules. The systems have multiple process capabilities allowing our customers to choose the best purification process for any given purification challenge:

• conventional batch and two-step connected batch for efficient high throughput batch purification
• periodic countercurrent processes (PCC) for continuous capture and polish purification
• novel processes for discovery applications facilitating the isolation of minor components from complex mixtures

Continuous manufacturing offers 30-50% reduction in CAPEX and OPEX compared to conventional batch manufacturing and is emerging to replace batch manufacturing. ChromaCon is unique in having a full range of process and process control patents and offering together with its scale-up partner a one-stop solution from laboratory to GMP process scale.

Clean Cells is a GMP-licensed Contract Development and Manufacturing Organization providing R&D, production and quality control testing services to the biopharmaceutical industry.
Our two-part site located in Western France holds an innovative process development platform, BSL2 and BSL3 GMP manufacturing laboratories and analytical areas to develop bespoke assays and perform GMP testing.
Clean Cells is part of the Clean Biologics group and benefits from the additional experience of sister company Naobios, a CDMO with considerable experience in the development and manufacture of virus-based products.

GMP XRPD and SAXS Studies of Pharmaceuticals
DANNALAB is an independent contract research company that specializes in physico-chemical studies of pharmaceuticals, biopharmaceuticals and drug delivery systems. To date we have successfully completed more than 450 projects, with 60+ active pharmaceutical substances.

Our core expertise relates to X-Ray Powder Diffraction (XRPD or XRD) and Small Angle X-Ray Scattering (SAXS), combined with a range of complementary techniques.

At DANNALAB we use XRPD (XRD) to identify the polymorphic type and crystallinity of an active pharmaceutical ingredient (API) in its pure form, as well as in formulation or dosage forms. We support our customers during research, pre-formulation and formulation stages. XRPD methods for API characterisation are also applied during stability studies and used for quality control during batch release.

Small Angle X-Ray Scattering (SAXS) to Study Drug Delivery Vehicles and Biologics:
We use SAXS to study the structure of drug delivery systems - micelles, liposomes and nanoparticulates. We also use SAXS to study the higher-order structure of biologics, their aggregation pathways and their stability patterns. You can find more information on our drug delivery and biopharmaceuticals pages.

Pharmaceutical Patents
To ensure effective and safe intellectual property management, we offer a range of services related to pharmaceutical patents.

Good manufacturing Paractice (GMP) Quality System
Among our services we offer method development and validation. Our facility and procedures are compliant with the cGMP quality system. The methods we offer are developed according to USP <941>, Ph.Eur. <2.9.33> and ICH guidelines.