Analytical Development

With top expertise in protein analytics, KBI has successfully completed over 3300 analytical projects for more than 300 clients and more than 130 distinct molecules. Our experience includes antibodies (IgG1, IgG4, IgM, FAb, ADC, Fc fusion), enzymes, cytokines, growth factors, highly glycosylated proteins,...

We Make it Work - For Every Molecule. Successful development relies on a deep understanding of a molecule’s unique characteristics. At Samsung Biologics, we have the knowledge and expertise to realize the true potential of your molecule, regardless of its complexity. By taking the right steps through ...

Testing for extractables and leachables: Our scientists perform extractables and leachables testing based on regionally specific guidelines (EU, US, China), nationally and internationally recognized standards (USP, ISO), GMP, PQRI recommendations, USP requirements (chapters <665>, <1663>, &l...

Solvias provides cGMP-compliant contract analytical services to help you ultimately provide safer products to consumers. We provide a comprehensive range of analytical services to the pharmaceutical, biotech, medical devices and cosmetics industry with similar regulatory requirements for raw materia...

Genovior Biotechnology Corporation facility capabilities & current ongoing production lines

We have extensive experience and know-how in the development of oral dosage forms containing spray dried powders. Tablets and capsules are the most common dry powder dosage form. However, other dosage forms such as sachets (bulk powders), vials (for reconstitution) have also be developed by the Upperton team.

ADAPTEK® TECHNOLOGY is the general name for our 4 international patents and expertise in nanotechnology and controlled release systems.This is a transversal technology that allows to develop customized biopolymeric nanohydrogels, allowing the load with different API (drugs, vitamins, growth factors, etc.)....

Our state-of-the-art laboratories offer a wide range of analytical services to support your exact needs under strict quality procedures which meet GMP requirements and following ICH guidelines.

The analytical department provides support during the development of drug formulations combini...

Pharmaffiliates is providing all the Analytical Services (i.e. Method Development, Method Validation & Transfer, Stability Studies, Contract Analysis, etc)

All Pharmaceutical Reference Standards are supplied with Certified COA along with supporting analytical data like HPLC, Mass, NMR, CMR, UV, IR, TGA, ROI, CHNS.

BioDuro-Sundia’s Analytical Testing team offers high quality analytical services including method development and validation, qualification of reference standards, testing and release studies, stability studies, and CMC dossier preparation services. ...

TECNALIA, experts in Pharmaceutical Development, Scale-up & Pilot Batches Manufacturing, Clinical Trials and Contract

Manufacturing ANALYTICAL DEVELOPMENT
• Monitoring of the first industrial manufacturing batches.
• Characterization of raw materials according to Pharmacopoeia. q...

Determination of physical, chemical and technical properties of substances and chemical products

Our analytical experienced team support the pharmaceutical development during every phase of the development process. Analytical development transfer and validation, characterization capabilities, stability analysis, ICH Q3D (residuals solvent risk assesment), ICHQ3C (elemental impurities risk assesment...

GVK BIO offers a range of Formulation R&D solutions that include pre-formulation studies, formulation development, analytical R&D, reformulation and stability studies. We can also support clinical supplies and manufacturing of exhibit batches in collaboration with our partners and offer standalone ...

Take no risk with your analytics when developing new therapeutic monoclonal antibodies. Our analytical teams take advantage of their extensive experience in the analysis of mAbs. Throughout non-clinical and clinical development, our experts provide you with the customised solutions in terms of analytical ...

Method Development and validation
Stability Studies
European testing & batch certification

Samples, bulk products or drugs: Our experts analyze your product and evaluate whether it meets all individual and regulatory requirements. 

Among others our modern laboratory is equipped with:

• HPLC-systems • Dissolution testing • UV/Vis- and atomic absorption spec...

Services for the development of inhalation drugs: Our team have over 30 years of experience supporting our clients' product development for orally inhaled or nasal drug products (OINDP). This includes formulation, stability, testing, product performance testing, in vitro bioequivalence studies, CMC...

Testing of pharmaceutical stability and ICH storage outsourcing: Our extensive capabilities cover all ICH conditions (or custom conditions), including climate control walk-in chambers, cabinets, refrigerated and freezer storage that are fully monitored and controlled, with backup units at every locatio...