DO YOU KNOW WHICH BRIDGE TO CROSS?

We help bridge the gap between your ongoing large molecule projects and your goals!

WIESLAB BIOANALYTICAL SERVICES

Answering to the complexities of large molecules

Scientific expertise & advanced technologies

During drug development there are many challenges to overcome. We help bridge the gap between your large molecule ongoing projects and your goals!

Our role, as bioanalytical service partner, is to facilitate your work and speed up your drug development process. Our GCP and GLP compliant laboratory delivers bioanalytical collaborative excellence in every project!

Our strategic location in the midst of the busy life science cluster of the Øresund Region, means that we are never far away and that we are surrounded by an abundance of potential partners that we can collaborate with to provide you with a full service CRO offering. 

Get to know Wieslab

GLP compliant laboratory

Wieslab Bioanalytical Services meets the GLP (Good Laboratory Practice) requirements set by the OECD. Swedac is a Swedish GLP authority, that is, the authority that tests and determines that laboratories meet GLP requirements and supervises these GLP laboratories.

GLP is a quality assurance system that covers the organisational process and the relations that prevail when non-clinical safety studies on humans and the environment are planned, carried out, supervised, and reported.

Benefits of GLP:

  • Full traceability of GLP study data
  • Compliant archiving of study data and records
  • Full compliance with regulatory requirements (OECD, EMA, US-FDA, US-EPA)
  • Acceptance of non-clinical safety study data by regulatory authorities in EU, US and worldwide

View GLP certificate

Bioanalytical Focus Areas

Immunogenicity Testing

Detection and confirmation of ADAs and NAbs

Pharmacokinetics (PK) & Pharmacodynamics (PD)

Expertise in bioanalysis of large molecules

Toxicokinetics (TK) testing

Assessment and characterization of biologic safety of large molecules

Biomarker testing

Over 250 immunology markers at your service

Potency Testing

Determinate the functional activity of your drug molecule

Consultancy Services

Optimize your study's assay strategy and improve submission success

WHO WE ARE

We are a bioanalytical CRO centered on large molecules (biologics and biosimilars) with a special focus on immune-mediated diseases. We provide services for non-clinical as well as Phase I - III and post-marketing clinical studies for pharma, CRO and biotech clients.

The experience in assay development / transfer and validation of immunoassays within our team of bioanalytical experts is extensive and they are always ready to discuss how to speed up your projects. 

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Scientific team

Our team of scientists averages 15+ years of post-schooling bench experience, with more than 65% comprised of PhD and Masters-level scientists that have been working with leading pharmaceutical and contract research organizations.

skills

Experience

Our experience runs deep, leveraging knowledge from +25 years of clinical diagnostic testing and immunoassay development, novel technologies and scientific expertise in immunological interactions, with more than 10 years experience as a bioanalytical CRO.

gdpr

Regulatory Compliance

High quality standards and processes are essential when working in bioanalytical projects. We offer ISO 15189, GCP and GLP compliant services ensuring that regulatory requirements are met for development, validation and sample analysis.

project

Project Management

Our ideal project management model provides a unique continuity, with a single point of contact and full visibility into project progress and costs at every stage. Our scientists have many years of experience in delivering high quality data, working according to applicable guidelines and regulations.

manufacture

Unique in-house
developed products

We offer proprietary off-the-shelf products, customized method development of our cell-based assays and immunoassays or utilization of our extensive portfolio of non-proprietary assays.

sharing

Industry & regulatory knowledge

Our scientists are actively involved in industry associations (EBF, EIP, AAPS & BEPBA) and contribute perspectives at scientific events. Hereby, we are always up-to-date with the latest bioanalytical approaches and guidelines in order to help our customers effectively navigate the ever-evolving scientific and regulatory complexities of biologics development.

success

Flawless Track Record

Through the many assays we have developed, we gained unprecedented knowledge and experience in how to shorten development timelines, optimize assay performance and determine the best analytical method for your biologic.

technical-support

Analytical technologies

We have access the best analytical technologies for drug development and clinical research applications, such as cell-based assays - iLite® technology, SIMOA, ELISA (Enzyme-linked Immunosorbent Assay) and Meso Scale Discovery (MSD). Read more...

Let us make a difference in
your drug development project!

 

Discuss Your Project
with Our Scientists Today!

Contact us