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Got particles?

We know the pain. We can help.

Every step of the way.

We solve technical challenges and regulatory hurdles related to:

Visual Inspection/ Visible Particles
Sub-visible Particles
Extractables & leachables
Surfactant degradation
 

Integrated Analytical Services

 
 
CLEAR SOLUTIONS LABORATORIES -
one-stop shop for analytical consulting and testing services:
  • Industry leading analytical consulting services
  • State of the art in house analytical testing capabilities
 
Clear Solutions provides specialty consultation and analyses for the Biotech sector.
We combine pharmaceutical experience with high end in-house analytical skills and capabilities to address the currently unmet demand for end-to-end investigational support in Pharma & Biotech
Clear Solutions is a one-stop shop for root cause investigations, pharma issue resolution, and solutions to a range of challenging development problems
 
We provide a unique offering of integrated analytical services, combining regulatory consultancy with specialized analytical testing
We have deep expertise, industry experience, and extensive drug development/ commercialization knowledge
 
 

Services

 
Visual inspection (VI)/ Visible Particles
  • Visual Inspection setup, including: - Setup of compliant Visual Inspection
    - VI test set design, manufacturing and qualification
    - Inspector training and on-site issue remediation
    - Health Authority questions support
  • Particle identification and characterization
  • Control strategy and specifications
Subvisible particles
  • Particle characterization
  • Control strategy and specifications
  • Issue remediation
  • Health Authority (HA) questions support
Surfactant Degradation
  • Polysorbate quantification and characterization method development
  • Polysorbate degradation characterization, including degradation mechanism diagnosis, Lipase activity assay
  • Root cause analyses
  • Control strategy setup and issue remediation (incl. process improvement support)
Extractables & Leachables
Stay tuned!
 

Our Team

 
Heidi Zhang
Chairperson of the Board
Roman Mathäs
CEO
Atanas Koulov
CSO
Andreas Zerr
 
Filip Fedorowicz
 
 

Scientific Advisory Board

 
 
Prof. John Carpenter
Scientific Advisory Board
 
 

Strategic partnerships

 
 
We are proud to announce that CLEAR SOLUTIONS LABORATORIES has entered into a strategic partnership with Material Analytischer Service (M.A.S.) GmbH.

M.A.S. GmbH has been a trusted supplier to Pharma and Biotech customers offering manufacturing of visual inspection kits for over 20 years.

Our strategic partnership with M.A.S. GmbH will enable CLEAR SOLUTIONS LABORATORIES to offer our clients seamless one-stop-shop Visible Particle offerings.
 

 
We are excited to announce that ClearSolutionsLaboratories has partnered with Lumetics, a cutting-edge provider of advanced particle characterization and machine learning software solutions. 

This partnership enables a joint offering to our clients providing advanced particle characterization and Machine Learning application support in conjunction with comprehensive automated data management analysis and reporting using the Lumetics LINK platform! 

Together, we also offer development of product-specific AI models for flow imaging microscopy particle classification, including experimental and computational support.
 

Got particles?

Issues with visible or sub-visible particles? Surfactant degradation?
We know the pain. We can help. Every step of the way.



CLEAR SOLUTIONS LABORATORIES AG

Address: Mattenstrasse 22, 4058 Basel, Switzerland
email: info@clearsolutions-labs.com

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