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

A specialized service laboratory - with 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 focus is on  large molecules with ligand binding assays and cell based assays and we have experience with antibody and peptide based drugs, new modalities, gene and vector based therapies.

Our strategic location in the midst of the busy Scandinavian life science cluster, means we are surrounded by an abundance of potential collaboration partners and can provide you with a complete  CRO offering. 

Get to know us

Our Bioanalytical Service Solutions

Bioanalysis as a critical tool during the process of drug discovery. Development and assays are continuously being developed  to support the various stages and requirements. We offer assay development, validation  and samples analysis within the following Bioanalytical Service Solutions. 

Bioanalytical Services Solutions

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

Our Bioanalytical Focus Areas

We put great emphasize on keeping up with the industry shifts and trends as a part of upholding premium scientific solutions. This involves constantly engaging in our Bioanalytical Focus areas.

We have experience in various disease and treatment areas including Oncology, Autoimmunity, Endocrine disorders and Neurology with various type of treatments such as; Antibody therapeutic and Immuno-Oncology, Cell and Gene Therapy and drugs based on small and large peptides. We have worked with drugs used in large treatment indications, pediatric indications, Biosimilars and with Orphan drugs.

Our mission is understanding how new assay and technology innovations, within each of these areas, can optimize and accelerate our sponsors work and deliver that expertise knowledge into the project we take on. 

GENE THERAPY
We help you navigate this complex area

The complexity and scope of  gene therapy may give you multiple considerations for your assay strategies. These may include questions regarding the selection of the right the analytical technology and methods associated with this technology.

We have the experience and knowledge to help you navigate this complex area.

ONCOLOGY & IMMUNO-ONCOLOGY
We help determine assay strategies and establish technologies 

The diversity and inherent power of the immune system has paved the way for new types of cancer therapies.

We can help to understand which assay strategies to use and  assist you in getting  non-invasive analytical tools for determining the efficacy of these cancer treatments. We can also help to establish which technologies should be used to be able to fast track studies for unmet cancer therapy needs.

BIOSIMILARS 
We design biosimilar assay strategies and develop customized methods

It is paramount for a biosimilar to show  comparability to its originator product - not only to ensure safety and efficacy, but also to allow for exchangeability.

We can help with design of bioanalytical biosimilar assay strategies as wells as developing customized methods not available off-the-shelf. 

SMALL PEPTIDES 
We assist with risk assessment and assay strategies

Peptides exert a wide range of specific functions as chemical messengers, hormones, intracellular/intercellular mediators and as specific stimulators and inhibitors. Drugs can be produced either by purifying the peptide from a host or by modifying and producing it as a more stable and clean form.

We have a deep understanding for the requirements of assay strategies for peptides , with a focus on immunogenicity, and can assist with immunogenicity risk assessment and assay strategies.

ORPHAN DRUGS & RARE DISEASES
We assist with risk assessment and assay strategies

An orphan drug is a pharmaceutical agent  to treat medical conditions which, since they are so rare, would not be profitable to produce without government assistance.

Orphan designation qualifies for various development incentives and we can assist with risk assessment and assay strategies within relevant service fields. 

CONSULTANCY ADVICE
We help improve the basis for decision making 

With our long track record and extensive knowledge within the bioanalytical field we can help improve the basis for decision making and strengthening the position towards regulatory authorities for our sponsors. 

Quality & Regulatory

GLP compliant laboratory

Wieslab Bioanalytical Services meets the GLP (Good Laboratory Practice) requirements set by the OECD.

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

Wieslab is listed in the OECD Good Laboratory Practice (GLP) Compliance Monitoring Programme with inspections performed by Swedish Board for Accreditation and Conformity Assessment (Swedac) as the only inspecting GLP authority in Sweden.

The Principles of GLP is also used for documentation and accountability of method validation and sample analysis under Good Clinical Practice (GCP).

 

Benefits of GLP:

  • Full traceability of 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

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your drug development project!

 

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