Dannalab B.V.

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

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.

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.

Idifarma is a Contract Development and Manufacturing Organization (CDMO) for small molecule oral drug development and manufacturing, with high potency and spray drying capabilities.

Idifarma is part of Ardena, your one-source partner to help you navigate the drug development process from molecule to clinic.

Ardena is a pharmaceutical CDMO that guides companies through the drug discovery and development process to help create effective and compliant drug substance and products for clinical trials.

Ardena provides you with an integrated service offering including solid state chemistry, API & nanomedicines development and manufacturing, analytical & formulation development, drug product manufacturing, bioanalytical, drug discovery and dossier development services.

Headquartered in Ghent, we have facilities in the Netherlands, Belgium, Sweden Latvia and Spain, serving a global customer base, ranging from emerging biotech to tier-one pharmaceutical companies.

We understand the complex challenges involved in taking a promising molecule from lab to patient.
Each project we undertake is preceded by a detailed planning phase to ensure that the right work is carried out at the right time. This staged approach allows you to stagger your investments and mitigate risks during each phase of the project.

Our integrated offering is the engine that drives all of our projects. Our multidisciplinary team is keen to streamline your development process.

We also make sure that all the work we do for you is compliant with the appropriate regulatory standards as you move along the clinical development path. Our dossier-centric approach is key to help you compile your regulatory dossier in a timely and cost-efficient manner. By preparing your regulatory dossier in parallel with drug development, we ultimately get your drug to patients faster.

Nova Laboratories is an independent contract manufacturer, that has established a worldwide reputation, for the aseptic processing of pharmaceutical, biotechnology and medical device products. This has been achieved as a result of it having a demonstrable track record of successfully applying its processes and technology to a significant number of challenging and novel applications.

Nova is one of the UK's leading independent providers of services to both the Pharmaceutical and Biotechnology sectors, and currently has

Aseptic Processing Capability for:

Emulsion manufacturing
Fill / Finish of Antibodies, Peptides, Plasmids & Proteins
Live Biologics
Lyophilisation
Medical Device assembly
Powder blending and filling
Spray Drying
Syringe Filling
Vial & Ampoule Filling

As well as it's aseptic manufacturing, Nova also has the facilities and expertise to offer the following non sterile manufacturing:

Specials
Clinical Trial materials
Contract Manufacturing

More recently, through its affiliate Nova Bio-Pharma Technologies Limited, Nova has gained access to two patented technologies that are aimed at making a variety of materials, but particularly Pharmaceutical and biotechnology ones, thermally stable at tropical temperatures i.e. remove the need for cold chain storage and distribution.

We also offer QP release, clinical trial labelling, process & formulation development, analytical services and expert technicla assistance, in support of our manufacturing operations.