Accepta Ltd

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.

FDAS is an experienced, accredited, Independent Contract Services performing chemical and microbiological services for the pharmaceutical industry, globally.
Our strength is the combination of technical experience with cost effective prices & outstanding customer service to fit in to any QMS.

Our experienced analytical team provide all the expertise needed to guarantee timely, accurate results that meet the requirements and rigours of any regulatory body.
The capabilities are listed but not exhaustive:

Raw Material analysis
API & Finished Product testing
Method Development & Validation
Technology Transfer
Stability studies (ICH/VICH)
Microbiological analysis
Technical advice / Consultancy/ Pre-formulation
USP/EP/BP/JP Tests

Customer listing from small companies to Blue Chip Pharmaceutical Global companies. Generic pharmaceutical testing is our speciality. Call us for more information or a confidential discussion.

DRUG DELIVERY SOLUTIONS - DRUG PRODUCT DEVELOPMENT - LICENSING-OUT OPPORTUNITIES

Galenix provides a range of full R&D pharmaceutical services and Drug Delivery Solutions to health companies for fast access of their products on the market.

●●● From the sourcing of the API through the Drug Product development process, including preformulation, formulation, to clinical supplies, quality control, ICH stabilities and regulatory dossier submission for Europe and US FDA registration.

Galenix provides its customers drug products “ready to launch” holding a Marketing Authorization.

●●● Galenix Innovations includes 6 different innovative technology platforms focusing on drug delivery solutions for life cycle management, new chemical entities and Biologicals using conventional medicinal presentations or its own patented technologies.

« Patients are central to our approaches »

Galenix team is focusing to preserve and/or to increase market shares on products through differentiation in accordance with regulations.

IBI Istituto Biochimico Italiano G. Lorenzini S.p.A. is a biopharmaceutical company with global reach. We stand out for our aseptic filling processes for injectable drug products and we have a consolidated leadership in penicillin market.

We are present in retail and hospital segment, export and for third parties completion.

Formulation, process development and manufacturing of chemical entities, proteins, biological and innovative delivery systems, from early stage to industrial scale up, are areas of intervention as CDMO in partnership with research institutes or private companies.

• GMP production for biological medicinal products (active substance from CHO cell culture, peptides, monoclonal antibodies)
• GMP production of sterile drug products
• GMP production of sterile API and finished products
• CDMO and GMP production for orals, topicals, injectables
• Aseptic filling of injectable medicinal products
• Micro and nanoparticles formulations aimed to delivery of different classes of active molecules
• Pharmaceutical development
• Analytical validations, stability testing
• MA and IMP registration and Batch Release services
• Investigational Medicinal Product production

IBI produces its products in conformity with the regulations of the European Pharmacopoeia and the cGMP norms and is certified by the most demanding Health Authorities: FDA, AIFA, EDQM, TGA.

CIR (Crédit d'Impôt Recherche) accreditation from the French Ministry of Research (Ministère de l'Enseignement Supérieur et de la Recherche) for 2016, 2017, 2018.

More information: www.ibi-lorenzini.com
Licencing in and licencing: bd@ibi-lorenzini.com
Pharmaceutical Development Services: pds@ibi-lorenzini.com

LEUKOCARE is a leading provider of technologies for biological functionalization of medical devices, as well as the stabilization and protection of proteins and biological molecules in biopharmaceutical formulations in order to ensure safety, to extend shelf-life and to enable terminal sterilization.
As a product-focused biotechnology company, LEUKOCARE uses its proprietary Stabilizing and Protecting Solutions (SPS) to leverage its comprehensive expertise in industrial co-development partnerships. The company offers its know-how in formulation of biologics, biofunctional coatings of combination devices and product development.
LEUKOCARE was founded in 2003 and is headquartered in Martinsried near Munich, Germany.