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...

SUPPORT SERVICES FOR OUR CONTRACTED CUSTOMERS • Analytical Development • Validation Support • Regulatory Support • Clinical Supply Services

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...

Due to their complex structure and size, as well as a constantly evolving regulatory landscape, the physico-chemical and biological characterisation of viral vector-based products is challenging.

With extensive experience in the analysis of innovative products and thanks to a ...

Automated Technology Platforms:

 
·         E-Scan MicroCurrent HVLDmc  parenterals

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

Phosfinity Quant

- accurate detection of polyphosphates (PolyP)
- applicable to virtually any sample matrix
- rapid workflow using an enzymatic assay

We offer the world first kit to precisely quantify polyphosphate of every chain length even down to PolyP2. Ev...

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...

The complete integration of analytical sciences into the process of API development is fundamentally understood at CARBOGEN AMCIS. Our scientists, technique ranges, systems (including a fully validated LIMS) and procedures facilitate a full understanding of the unique characteristics of the complex molecul...

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...

Potentiometric titrator is used to determine the purity of a substance as per standard method. Suitable for Aqueous, Non-Aqueous and Red-Ox titrations, TAN /TBN titrations, Assay determination, Chloride and Bromide analysis,  Di-Azotization titrations,  Iodine number and Saponificatio...

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...

Our analytical portfolio comprises 100+ different techniques – all performed by Coriolis’ experts in-house. Our offering includes:
• Aggregate analytics • Particle characterization • Particle identification • Surfactant characterization • Higher order structure analysis • Funcional assays • Chemi...

• Setup and development of analytical methods • Analytical support to formulation and process studies • QC testing of batches involved in in-vivo studies and supervision of bioanalysis • QC Testing of GMP batches • Microbiology (monitoring of GMP Pilot Plant) • Non-G...

Oasis Test House caters to the microbiological requirements for its clients serving them with the below analysis. • Preservative Efficacy Analysis • Sterility Test • Sterility Validation • Microbial Limit Test Validation • Microbial count and pathogens • Bioburden testing • Antibiotics assay • Vitam...

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

Actylis performs routine and non-routine analytical testing for various industries, in support of manufacturing processes, QA/QC functions, R&D projects, and environmental applications. Leveraging state-of-the-art instrumentation, extensive knowledge base, as well as internal, cross-functional comp...

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...