CatSci Ltd

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.

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.

Pharmaceutical Development Services Limited is a pharmaceutical consultancy assisting clients with regulatory, quality and manufacturing services in Europe for pharmaceutical products and medical devices. We specialise in assisting US companies perform clinical trials and market products in Europe and offer a turnkey operation if required.

PDS was formed in 2000 and has an extensive network of consultants who provide detailed and up to date specialist technical knowledge. PDS consultants also work as experienced interim managers for senior positions in Regulatory Affairs, Pharmaceutical Development and Quality Assurance.

PDS works with a range of clients from small start- up biotechnology companies to large multi-national pharmaceutical companies.

Contractor Management:
PDS consultants assist companies in the placing of work with CROs from the preclinical stage to Phase 3.

Technical Development:
PDS advises companies on the strategy for introducing a new product, from pre-clinical technical development to a multi-national commercial launch.

Regulatory Affairs:
PDS provides strategic regulatory advice and support for agency submissions, due diligence and writing regulatory dossiers. From small molecules to botechnology compounds, PDS has expertise with herbal medicines, nutraceuticals, cosmetics and medical devices.

Training:
We provide expert in-house and public training courses through our sister business PharmaTraining Services (www.pharma-training-courses.com).

Transforming proteins into pioneering drugs

ProJect Pharmaceutics, based in Martinsried/Munich, Germany, transforms proteins, peptides and delicate small molecules into pioneering drugs. ProJect Pharmaceutics adds value to client´s bio-pharmaceutical products by applying an innovative concept of development called Advaceutics. Based on the Advaceutics concept, ProJect Pharmaceutics designs optimized formulations and delivery systems for biologics that are stable, convenient and safe. Tailored to these optimized systems the company develops cost-effective manufacturing processes and transfers those from its own pilot labs to large-scale manufacturing. ProJect Pharmaceutics makes sure that investigational products, biosimilars as well as “bio-betters” are developed effectively and will run smoothly in clinical and commercial scale GMP manufacturing.

We offer:
• predictive formulation analytics
• formulation development including in-depth protein analytics
• lyophilization process development and optimization
• lyophilization in dual chamber prefilled syringe
• development of liposomal formulations, producible by simple stirring
• manufacturing of preclinical study material
• technology-transfer including scale-up to GMP-manufacturer

We deliver:
• optimized formulations for biopharmaceuticals
• tailored manufacturing processes and transfer to GMP manufacturing
• development reports ready for submission to the authorities for registration

Our injectable and solid form products are manufactured in the Madrid metropolitan area in Spain. These CMO (or Contract Manufacturing Organizations) facilities are owned by ROVI Pharma Industrial Services®, a specialized Spanish pharmaceutical company, fully dedicated to research, development, manufacture and marketing of small molecules and biologicals.

In 2012, ROVI’s injectable plants received FDA approval.

From project development to product release, as well as pilot and industrial batches, ROVI® brings all of these services into a single company, allowing our clients to save considerable time and money as a result.