Bio Analytical Services

Bioanalysis Services: We offer GLP/GCP-compliant method development, validation, method transfer, sample analysis, and pharmacokinetic/toxicokinetic support - all delivered from our state-of-the-art facilities and supported by automated data collection and reporting systems. For over 30 years, we have supp...

Lambda provides regulated bioanalytical support for large molecules, biologics and biosimilars across clinical development. Capabilities include large-molecule PK analysis, anti-drug antibody assessment, neutralizing antibody testing, pharmacodynamic biomarkers, functional bioassays, immunogenicity assessm...

We provide analytical services from pre-clinical studies through Phase III, including full statistical evaluation. Our experienced team has successfully completed more than 780 biostudies for pharmaceutical companies across Europe, the United States, Asia, and Australia.

The Bioanalytical de...

State-of-the-art phase I/ll unit supporting complex clinical trials First in Human ( FIH) to Proof of Concept ( PoC) Clinical pharmacology studies through all phases In-house safety lab and bioanalytical services Special patient populations (with a focus on respiratory) Data management, regulatory sup...

Kymos Pharma Services, S.L. offers wide range of bionalysis services in medicinal chemistry which includes bioequivalence studies. Kymos are experts in bioanalysis for bioequivalence studies in collaboration with the sponsor and/or the selected clinical phase center. It has a long list of validated bioanal...

Coriolis Pharma’s team of experts specializes in lyophilization, bringing extensive experience in developing, optimizing, scaling up, and transferring lyophilization cycles for biopharmaceutical drug products. Our advanced approaches are designed to create robust, economical freeze-drying cycles by impleme...

We are a GLP lab specialist in vitro permeation testing, including the bioequivalence tests under the EMA draft guideline. We support pharmaceutical companies through bioequivalence studies. Visit our booth and find out more about our R&D dedicated to this topic.

SERVICES Kemwell provides integrated development and manufacturing services for companies that require one-stop solution for mammalian cell-culture based protein therapeutics The team is experienced to undertake end-to-end activities right from cell line development till cGMP clinical and commercial manufa...

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...

Generic manufacturers registering into CARICOM run their bioequivalence studies outside the region or through a small number of bridging facilities elsewhere in the Caribbean. Either route adds cost and schedule to every submission, with in vivo studies running to six figures per product.

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Seplife® EMC resins are robust enzyme carriers designed for research and industrial applications. The variability in functional groups, porosities, matrices, and particle sizes offers the widest toolbox for enzyme immobilization.

Mabion offers a extensive suite of Analytical Services to ensure safety, efficacy and quality of your biologic product. Our portfolio includes development, optimization and validation of analytical methods, as well as stability studies, GMP release testing and in-depth drug characterization. In addition to...

At Selvita, we offer comprehensive bioanalytical services for a wide range of biological drugs, including innovative proteins, biosimilars, therapeutic peptides and enzymes, biomarkers, monoclonal antibodies, hormones, nucleic acids, and other large molecules. As a GLP-certified and GCP-compliant multinati...

Experienced cell-based neutralizing antibody assay capabilities. Our experts, at our GLP/GCP compliant laboratory, evaluate each therapeutic, conduct tailored assay development and ensure that each assay is optimized to suitably determine the presence of NAb with maximum possible level of drug toleran...

We design bespoke analytical programmes that ensure that the relevant quality attributes for your drug substance or product are evaluated to support your manufacturing process changes. We select analytics referenced by the ICH Q6B to examine the product's structural features (primary, secondary and&nb...

QC testing of pharmaceutical raw materials to international pharmacopoeia specifications has become a specialty of Intertek. With our knowledge of analytical chemistry and our vast range of instrumental techniques, we can undertake the vast majority of the chemical tests listed within the international pha...

Lambda provides integrated laboratory services spanning regulated bioanalysis, biosimilar development and central clinical laboratory testing. Capabilities support clinical development through bioanalytical testing, immunogenicity assessment, biomarker analysis and clinical laboratory testing. The central...

Our analytical portfolio comprises 200+ 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...

Kymos Pharma Services, S.L. offers wide range of bionalysis services in medicinal chemistry which includes bioanalysis of small molecules. Kymos offer bioanalytical method development and validation of innovative small molecules by mass spectrometry. It has the experience of being the selected partner for ...

Kymos Pharma Services, S.L. offers wide range of bionalysis services in medicinal chemistry which includes immunogenicity. Kymos have develops new bioanalytical methods for immunogenicity studies of proteins and peptides following ema and fda guidelines on immunogenicity of therapeutic proteins. Depending ...