Analytical Methods

KBI's Cell Therapy team, located in The Woodlands, TX, has managed a fully functional manufacturing facility supporting cell therapies and developing therapies under IND since 2001. Our team has substantial expertise and knowledge in cellular therapies' manufacturing, process development, and regulato...

Analytical development services for oligonucleotides: For oligo-based drugs, our capabilities range from GLP bioanalysis to GLP/cGMP characterisation. We support product development, from quality control testing of amidite starting materials and early stage product characterization through to GMP batch r...

From our state-of-the-art analytical laboratories in the UK and US, our highly skilled analysts deliver comprehensive solutions to support drug substance (API) and drug product development programs. Analytical and microbiological testing solutions for clinical and commercial drug product supply are also pr...

Automated Technology Platforms:

 
·         E-Scan MicroCurrent HVLDmc  parenterals

·         Vacuum Decay technology for parenterals and other pharmaceutical container format...

The Gasporox sensor series GasSpect offers non-destructive Headspace Gas Analysis to be integrated into an inspection machine. The sensors with its highly sensitive laser impresses with performance and precision. The GasSpect series comes in different variations depending on which gas to be inspect...

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...

Accelerating molecules through to proof-of-concept - Simplify early development and accelerate to Proof-of Concept.Proof-of-concept (POC) is a key milestone in the development of a new drug candidate. We understand the transition to POC needs to be fast and cost-effective.With fully integrated capabil...

By the end of 2017 we will have a MHRA, GMP licenced laboratory. We will be offering a wide range of services for routine Quality Control analysis including QC release testing, method validation and stability analysis (analytical and microbiological). We work to the highest standards of GMP and GLP with r...

With a full analytical package for Biologics, Quality Assistance provides scientific and technical support to biopharmaceutical companies developing Antibody-Drug Conjugates. Thanks to our combined experience with small molecule cytotoxics and monoclonal antibodies, we can provide full ana...

Avara Pharmaceutical Services offers development support services including analytical methods development. Contact us for more information.

Also known as y-site studies, compatibility testing is performed to ensure that the mixing of two different formulations does not impact the physical or chemical properties of the drugs.

Inhalation product analysis and testing services include particle size and droplet characterization, delivered dose testing, as well as aerodynamic particle size analysis – for pressurized metered-dose inhalers (PMDI), dry powder inhalers (DPI), nebulizers, and soft mist inhalers. Our Good Manufacturin...

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...

Analytical methods development and validation: Our method development scientists work with a broad range of products, methods, and analytical technologies (chromatography, mass spectrometry, spectroscopy, biophysical analysis, bioanalytical techniques, etc.) to ensure that the method will meet its int...

Characterization and testing of biopharmaceuticals: Using our expert's insight into a biologic's structure, physicochemical properties, potency, and impurity profile, we help you meet your development milestones.

A range of expertise is available, including assessment of structure...

Characterization and release testing of gene therapies: supporting CMC requirements for IND applications and commercial release through expert analysis and stability testing. We provide method development and validation to meet your milestone and regulatory requirement and help you to confirm identity a...

To meet your analytical needs, Quality Assistance provides you with scientific and technical support for the development of your New Chemical Entities. Our added-value brings together a sound expertise in small molecules analytical development with state-of-the-art facilities and equipment, all o...

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 ...

Quality Assistance covers all the analytical technologies needed to support your drug development process: CMC (Quality) studies to be perfomed, including Ab characterisation, development and validation of analytical methods, stability studies and batch testing. For Bioanalysis to be performed in Non-clini...

Thanks to 35 years’ experience in analytical sciences and all our laboratories on one site (Mass Spectrometry, Physico-chemistry, Cell Biology, MolecularBiology and Microbiology), Quality Assistance covers all the analytical technologies needed to support your drug development process i...