IND Enabling Studies – Nonclinical GLP Safety Assessments
GLP/GMP-certified preclinical safety studies for your IND submission
Performing GLP Studies with InnoSer’s Support
Good Laboratory Practice (GLP) defines the quality standards required to ensure that your nonclinical safety studies are reliable, traceable and suitable for regulatory submission. However, GLP guidelines do not determine which studies should be performed. The appropriate study design depends on the therapeutic modality, mechanism of action, intended clinical use and regulatory requirements.
As a specialist preclinical CRO, InnoSer supports sponsors in designing and executing GLP toxicology programmes tailored to their specific development needs. By combining expertise in exploratory pharmacology, translational models, immunotoxicology and GLP toxicology, we help you identify the most relevant test systems and endpoints to generate meaningful safety data.
Our GLP capabilities support a wide range of therapeutic modalities, including small molecules, biologics, RNA therapeutics, cell and gene therapies. Study designs may include repeated-dose toxicity, safety pharmacology, immunotoxicity assessment, immunogenicity testing, biodistribution studies and other modality-specific non-clinical safety evaluations.
✓ GLP-certified since 2004: GLP toxicology studies and immunotoxicology/immunogenicity assessments
✓ GMP certified since 2007: in vivo adventitious virus testing & potency testing of recombinant vaccines
✓ 25 years of preclinical safety expertise: founded 2001 · EU-based · Gronau, Germany
✓ OECD · ICH S6 · ICH S8 · ISO 10993 · EMA/FDA aligned
✓ 2 GxP archives · full audit trail · client audit rights
Guesswork slows down IND submissions. GLP-compliant nonclinical safety data, tailored to your program, keeps things moving.
COLLABORATIVE SCIENTIFIC GUIDANCE
Work directly with experienced toxicologists and study directors throughout planning, execution, and reporting.
TAILORED STUDY DESIGN
No one-size-fits-all approach. Study strategies are adapted to your molecule, mechanism of action, and development stage.
AGILE SUPPORT FROM EXPLORATORY TO GLP
Integrate existing pharmacology data and translational insights to build efficient safety packages and avoid unnecessary studies.
What studies does InnoSer offer under GLP/GMP?
Chemical testing in accordance with OECD guidelines
- OECD 417 – Toxicokinetic
- OECD 402 – Acute Dermal Toxicity
- OECD 420 – Acute Oral Toxicity – Fixed Dose Procedure
- OECD 423 – Acute Oral toxicity – Acute Toxic Class Method
- OECD 425– Acute Oral toxicity – Up and Down Procedure
- OECD 407 – Repeated Dose 28-day Oral Toxicity Study in Rodents
- OECD 408 – Repeated Dose 90-Day Oral Toxicity Study in Rodents
- OECD 410 – Repeated Dose Dermal Toxicity: 21/28-day Study
- OECD 411 – Subchronic Dermal Toxicity: 90-day Study
- OECD 452 – Chronic Toxicity Studies
- OECD 453 – Combined Chronic Toxicity/Carcinogenicity Studies
- OECD 451 – Carcinogenicity Studies
- OECD 414 – Prenatal Development Toxicity Study
- OECD 416 – Two-Generation Reproduction Toxicity
- OECD 421 – Reproduction/Developmental Toxicity Screening Test
- OECD 422 – Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test
- OECD 443- Extended One-Generation Reproductive Toxicity Study
- OECD 442 B – Skin Sensitization
- OECD 474: Mammalian Erythrocyte Micronucleus Test
Medical Device testing in accordance with ISO10993 guidelines
- ISO10993-1 Requirements and general principles for the evaluation of biological safety within a risk management process
- ISO10993-2: Animal welfare requirements
- ISO10993-12: Sample preparation and reference materials.
- Under consideration of ISO10993-17: Toxicological risk assessment of medical device constituents
- ISO10993-18: Chemical characterization of medical device materials within a risk management process
- ISO/TR10993-19: Nano-technologies – Considerations for performing toxicokinetic studies with nanomaterials, etc.
Food testing in accordance with EFSA guidelines for novel foods and ingredients, food additives and flavourings, food contact materials
- Toxicology testing in accordance with EFSA and OECD guidance documents
- Repeated dose administrations via oral gavage or feed
(Bio)Pharmaceuticals (EMA) - Testings in accordance with ICH M3 (R2) and ICH S6 (Biotechnological Products)
- Local tolerance
- Carcinogenicity (S1)
- Toxicokinetics & Pharmacokinetics (S3)
- Toxicity testing (S4), Repeated Dose Toxicity
- Reprotoxicity (S5)
- Immunotoxicology Studies (S8)
- Non-clinical Biodistribution considerations for Gene therapy products (S12)
- Immunology assays: in vivo, TDAR assay (KLH), Delayed type hypersensitivity, Sensitization (mLLNA)
- Autoimmunity studies
- Tumorigenicity/ oncogenicity
- Vaccine studies
- Potency assays/ efficacy studies
- Histopathology of Immune organs
- Differential blood counts
- ex-vivo/ in vitro Immunophenotyping (FC) of leucocytes and lymphocytes, Cytokine release (FC, CBA), NK-activity ex vivo and following in vitro stimulation
- Antigen dependent T-cell proliferation (ELISPOT)
- Mitogen dependent proliferation (BrdU)
- Phagocytosis of macrophages from peritoneal exudates
- Complement activation (MAC, CARPA, ELISA)
- Serological quantification of antibody concentrations/ isotype distribution
- Pharmacological in vitro studies
- Pharmacokinetics of biologicals (direct / biomarkers)
- Anti-drug antibody assays (screening / confirmatory ADA)
- Immunohistological analytics
- Detection of specific antigens in selected tissues
- Enzyme-linked detection systems
- Semi-quantitative analysis and analytics of IHC
- in vivo analysis for adventitious viruses in accordance with European Pharmacopoeia 2.6.16 (Ph.Eur.), ICH guideline Q5A (CPMP/ICH/295/95) Points to Consider PTC (1993)
Every molecule is different. Your GLP strategy should be too.
Work with our team to evaluate your drug and target for therapeutic effects with precision and expertise
The People Behind Your Research
Dr. Marion Hecht, PhD
Director of Operations, InnoSer Deutschland
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AAALAC Accreditation
InnoSer has earned the AAALAC accreditation, demonstrating our commitment to responsible animal care and use. AAALAC International is a nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. InnoSer’s facilities in the Netherlands and Belgium have been AAALAC-accredited since 2016 and 2020, respectively. Read more about the AAALAC accreditation programme here.
Animal Welfare
The 3Rs impact everything from policy and regulatory change to the development and uptake of new technologies and approaches. This is why InnoSer has ongoing commitment and monitoring of these processes. The steps we practice maximize our ability to replace, reduce and refine animal involvement and facilitate our commitment to these principles when it comes to research and drug development.
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