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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: [email protected]