Analytical Methods (Biopharmaceutical Products)

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...

• Control of pharma samples solid state : Identification and quantification of solid state, method development and validation, routine QC. • Analytical techniques available : XRPD, DSC, TGA, DVS, Laser PSD, FTIR, IDR. • All analyses are applicable to toxic samples down to : 50 n...

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...

Through advanced laser imaging techniques, we provide analytical services to support the qualification and validation of spray devices. Testing services on pharmaceutical inhaled drug delivery devices are performed with high-speed imaging to evaluate the dynamic performance of devices by looking at its...

In response to nitrosamines present in pharmaceutical products, the European Medical Agency (EMA) and the US Food and Drug Administration (US FDA) have published requirements and limits related to nitrosamine contaminants. Therefore Brightlabs has developed and validated multiple methods to determine low l...

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.

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

HPLC columns from VDS optilab have been impressed customers from all areas of analytics, ranging from universities and government agencies to small and medium-sized companies and large companies in the chemical and pharmaceutical industries. Benefit from the advantages of the VDSpher phases product fa...

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 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...

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...

Neotron Pharma is able to validate analytical methods developed internally or transmitted by the customer using top of the range equipment such as:
- HPLC-UV / DAD / MSMS
- GC-FID / ECD / MSMS (even in Headspace)
- ICP-MS / AAS / AES / OES
- Post-column derivatization
- Particle si...

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...

Collect all your pharma/biotech data, monitor Pharma OEE and machine utilization, streamline order flow and production execution and achieve operational efficiencies by reducing production costs and increasing throughput

Enable GxP AI Industrialization to anticipate your best next action, optimize CQAs, increase yield, achieve RFT and OTIF.

Embrace process intelligence with Aizon Predict. Fine-tune yields, cut deviations, and anticipate maintenance effortlessly. Maximize capacity and ensure sustainability with o...

Coordinating in-process and finished product testing with the completion of batch documentation, we can deliver your drug product within just six weeks of the date of manufacture.

Symbiosis Pharmaceutical Services can manage all of your analytical and microbiologial testing requirements by utili...

At Selvita, we understand that robust and reliable analytical methods are critical to the success of drug development. Our approach to analytical method development, optimization, qualification, and validation is rooted in our extensive expertise and commitment to excellence. Here’s how we ensure that our ...

• 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...