European Pharmaceutical Review
Harke Pharma is a business unit of HARKE GROUP with over 35 years of experience in distributing pharmaceutical excipients and APIs. They support the industry in drug formulation and offer innovative products from top suppliers. The company has a strong presence across Europe with local teams in multiple countries, and is part of the family-owned HARKE GROUP, which focuses on chemical distribution and contract packing. The company emphasizes the importance of sterile manufacturing processes, environmental control, and advanced packaging solutions to ensure product safety and efficacy.
Industries
Nr. of Employees
medium (51-250)
European Pharmaceutical Review
Products
Capsule dosage-form portfolio
Range of capsule dosage forms including plant-derived polymer capsules and inhalation-compatible capsules suitable for clinical supply.
Microscopy and imaging instrument portfolio
Optical, digital, confocal and super-resolution microscopy instruments and associated imaging systems for laboratory and clinical analysis.
Single-use bioprocessing consumables and systems
Single-use bags, films, single-use bioreactors, mixing and microcarrier separation systems designed for scalable biologics manufacturing and cold-chain distribution.
Endotoxin assay platforms and QC reference materials
Endotoxin testing platforms including recombinant Factor C assays and quantitative microbial control materials to support endotoxin method validation and QC.
Automated PCR-based mycoplasma testing system
Fully or near-fully automated PCR platform for mycoplasma detection enabling rapid release testing and routine QC screening.
Inline nanoparticle size analyser for PAT
Non-invasive inline particle-size analyser using SR-DLS for real-time monitoring of nanosuspensions and lipid nanoparticles during manufacturing.
Capsule dosage-form portfolio
Range of capsule dosage forms including plant-derived polymer capsules and inhalation-compatible capsules suitable for clinical supply.
Microscopy and imaging instrument portfolio
Optical, digital, confocal and super-resolution microscopy instruments and associated imaging systems for laboratory and clinical analysis.
Single-use bioprocessing consumables and systems
Single-use bags, films, single-use bioreactors, mixing and microcarrier separation systems designed for scalable biologics manufacturing and cold-chain distribution.
Endotoxin assay platforms and QC reference materials
Endotoxin testing platforms including recombinant Factor C assays and quantitative microbial control materials to support endotoxin method validation and QC.
Automated PCR-based mycoplasma testing system
Fully or near-fully automated PCR platform for mycoplasma detection enabling rapid release testing and routine QC screening.
Inline nanoparticle size analyser for PAT
Non-invasive inline particle-size analyser using SR-DLS for real-time monitoring of nanosuspensions and lipid nanoparticles during manufacturing.
Services
Excipients and API distribution
Supply and logistics of pharmaceutical excipients and active ingredients with regional technical support.
Capsule manufacturing and clinical supply
Contract manufacture of oral and inhalation capsule dosage forms and clinical-trial supply with supporting regulatory documentation.
Microscopy instruments, service and training
Provision of optical and digital microscopy instruments, application support, workflow integration and training for analytical and clinical environments.
Single-use bioprocess components and customisation
Supply, rapid customisation and technical consultancy for single-use bags, films, bioreactors, mixers and separation systems, with cold-chain guidance.
Packaging safety, usability testing and design consultancy
Child-resistance and adult ease-of-opening testing using ISO panel methods, accessibility design for elderly users (ISO 17480 guidance), and packaging design consultancy including multilaminate blister solutions.
Advanced microbiological and immunogenicity testing for biologics
Analytical and cell-based services including endotoxin assays (including rFC), TLR reporter assays, monocyte activation tests, flow-cytometry immune readouts, demasking/pre-treatment protocols and host-cell impurity analysis.
Excipients and API distribution
Supply and logistics of pharmaceutical excipients and active ingredients with regional technical support.
Capsule manufacturing and clinical supply
Contract manufacture of oral and inhalation capsule dosage forms and clinical-trial supply with supporting regulatory documentation.
Microscopy instruments, service and training
Provision of optical and digital microscopy instruments, application support, workflow integration and training for analytical and clinical environments.
Single-use bioprocess components and customisation
Supply, rapid customisation and technical consultancy for single-use bags, films, bioreactors, mixers and separation systems, with cold-chain guidance.
Packaging safety, usability testing and design consultancy
Child-resistance and adult ease-of-opening testing using ISO panel methods, accessibility design for elderly users (ISO 17480 guidance), and packaging design consultancy including multilaminate blister solutions.
Advanced microbiological and immunogenicity testing for biologics
Analytical and cell-based services including endotoxin assays (including rFC), TLR reporter assays, monocyte activation tests, flow-cytometry immune readouts, demasking/pre-treatment protocols and host-cell impurity analysis.
Expertise Areas
- Pharmaceutical excipient and API distribution
- Drug formulation support and developability assessment
- Capsule dosage-form development and contract manufacture
- Microscopy and advanced imaging workflows
Key Technologies
- Recombinant Factor C (rFC) endotoxin assays
- Rapid microbiological methods (RMM) and environmental monitoring platforms
- Automated PCR-based mycoplasma testing
- Mass spectrometry-based microorganism identification