Analytical Methods (Biopharmaceutical Services)

The loVol®  is a specialized system engineered for low-volume solubility and dissolution testing. Designed for early-stage drug development and formulation screening, loVolr evaluates APIs, powder mixtures, granules, coated pellets, and finished oral dosage forms under both constant pH and dynamic pH ...

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...

Access the world’s scientific knowledge and advance your research. Use a combination of powerful search tools in CAS SciFinder and chat conversationally with our agentic AI tool CAS Newton to uncover trusted information found in journals and patents across multiple disciplines quickly and easily, and ident...

QACS Lab provides Extractables & Leachables (E&L) studies to support pharmaceutical, biotechnology and medical device industries in evaluating potential chemical substances that may migrate into final products. Our studies help ensure patient safety, product quality and regulatory compliance by ide...

We offer the development and validation of test methods for identity testing, assay, purity testing and in vitro dissolution for active ingredients, excipients, intermediates, finished products and substance-based medical devices. Our method development and method validation are in accordance wit...

From early development, including mammalian cell line development, cell culture development, and process development, through to pre-clinical production and commercial supply, Patheon by Thermo Fisher Scientific provides CDMO services for protein-based biologic therapeutics. Patheon offers biotech and ...

Alcami offers fully-integrated analytical method development, method validation and testing solutions for raw materials, API/BDS and Drug Product.Built on a foundation of comprehensive analytical services for pharmaceuticals including biologics, our advanced laboratories and experienced scientist...

Coriolis Pharma offers release testing services to ensure that drug products meet their intended target product profile, safety, efficacy, and regulatory standards. Our analytical offerings include both compendial and custom methods for purity, identity, potency, particle and aggregate analysis, polysorbat...

From a drug product’s first raw materials to its release-ready batches, our experts rigorously evaluate and verify a product’s quality at key steps throughout the manufacturing process. Analytical services include material testing to verify product quality from the early stages of development, cGMP-com...

PTI’s non-destructive inspection technologies verify container closure system integrity. Deterministic quantitative leak test methods for vials, ampoules, syringes, cartridges and auto-injectors. Applications include stability studies, clinical trials, quality assurance testing and statistical process cont...

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

ICON’s Accelerated Pharmaceutical Solutions provide a seamless, end-to-end approach to formulation development and optimisation for small molecules and biologics. Our comprehensive services cover everything from formulation screening and optimisation to analytical method development, validation, and custom...

Our PhysioCell: 

 - simulates crucial conditions of the upper GIT and is based on three-compartmental flow-through construction,


- features simulation of: gastric motility, constant or variable kinetics of the gastric emptying of non-caloric liquids, temperature gradients of the...

The pHysio-grad® device: 
- Can precisely monitor and adjust the pH value of commonly used hydrogen carbonate buffers the pH adjustment in the range of pH 5.5 to 8.3 with a maximum deviation of ± 0.02 pH units.

- Utilizes pure CO2 and inert gases for simulation of intestinal condi...

Comprehensive GI Transit Simulation using AMP™

Using our versatile AMP™ dissolution platform, we accurately replicate both fasted and fed states by simulating the full complexity of gastrointestinal transit:

• Biorelevant Media: Customized media including hydrogen carbonate buffers, ...

Key Capabilities

- Simulation of proximal GI tract: Replicates dynamic pressure events, pH shifts, flow rates, and thermal gradients.


- Intestinal Realism: Simulates rapid duodenal neutralization and dynamic carbonate buffer interactions


- Integrated PK Insights: Driven by prop...

We offer: 

- Chemical Stability Screening that includes the check on the API robustness across gastric and intestinal pH ranges, including nutrient-rich fed-state media such as milk, lipid emulsions, and simulated chyme.

- Check on Enzymatic Degradation that determines API bre...

We provide support in developing analytical methods using UV-VIS spectroscopy, High-Performance Liquid Chromatography, and Ultra-Performance Liquid Chromatography for the quantification of small molecules and biomolecules. Our particular strength lies in creating robust methods for samples in complex disso...

The disintegration test holds a special place at Physiolution. This simple, yet powerful experiment provides answers to big questions: does the formulation disintegrate well if the temperature gradient of the dissolution medium is applied? Or when the medium has a composition and a consistency of a digeste...