Lab services
Linneo is widening its services portfolio to provide state-of-the-art Laboratory Services in one single contract, one-stop-shop to reduce administrative costs and time.
Company overview
Linneo Health is a pioneering pharmaceutical company in the medicinal cannabis market. We have become a global leader in the research, production and distribution of cannabis for medical use.
Our facilities and production processes comply with European manufacturing standards EU – GMP and GACP. Our laboratory, one of the most advanced in Europe, allows us to comply with the most rigorous quality control standards globally.
We have one of the most sophisticated and well-equipped EU-GMP certified analytical parks in the industry. We also have a highly qualified and committed technical team with extensive experience in the sector.
Our facilities and production processes comply with European manufacturing standards EU – GMP and GACP. Our laboratory, one of the most advanced in Europe, allows us to comply with the most rigorous quality control standards globally.
We have one of the most sophisticated and well-equipped EU-GMP certified analytical parks in the industry. We also have a highly qualified and committed technical team with extensive experience in the sector.
Our Laboratory Services
Stability studies
Storage and Stability testing for Climatic Zones II and Iva (ICH Q1A (R2)
• Long Term (25ºC ± 2ºC/60% RH ± 5% RH
or 30ºC ± 2ºC/65% RH ± 5% RH)
• Intermediate (30ºC ± 2ºC/65% RH ± 5% RH)
• Accelerated (40ºC ± 2ºC/75% RH ± 5% RH)
• Intermediate (30ºC ± 2ºC/65% RH ± 5% RH)
• Accelerated (40ºC ± 2ºC/75% RH ± 5% RH)
Quality control in purified water
• Physico-Chemical analyses
• Microbiologic analyses
• Microbiologic analyses
Quality control Cannabis-based products (according to DAB and Ph. Eur.)
PHYSICO CHEMICAL ANALYSES
• Macroscopic and microscopic identification/foreign matters / cannabinoid content
analyses by HPLC-DAD and HPLC
• Cannabinoid profile identification by HPLC-DAD: delta-9-tetrahydrocannabinol (THC), delta-9-tetrahydrocannabinolic acid (THC-A), cannabidiol (CBD), cannabidiolic acid (CBD-A), delta-8-tetrahycrocannabinol (THC). cannabinol (CBN), cannabichromene (CBC), cannabichromene acid (CBCA), canaigre (CBG), cannabigerol acid (CBGA), delta-9- tetrahydrocannabivarin (THVC), cannabidivarin (CBDV)
• Determination of Moisture by Loss on Drying in Vacuum Oven and Karl Fisher
• Mycotoxin Analyses: Aflatoxins and Ochratoxin A
• Heavy Metals: Cadmium, Mercury, Lead, Arsenic, Niquel and Zinc • Total Ash and Sulfuric Ash • Analyses of pesticides: multiresidue pesticides • Terpene profile. MICROBIOLOGICAL ANALYSES • Mold and Yeast (TYMC) • Total Aerobes (TAMC) • Enterobacteria, Pseudomonas aeruginosa, Staphyloccoccus aureus, Escherichia coli, Salmonella spp, Shigella spp, Listeria Monocytogene
• Cannabinoid profile identification by HPLC-DAD: delta-9-tetrahydrocannabinol (THC), delta-9-tetrahydrocannabinolic acid (THC-A), cannabidiol (CBD), cannabidiolic acid (CBD-A), delta-8-tetrahycrocannabinol (THC). cannabinol (CBN), cannabichromene (CBC), cannabichromene acid (CBCA), canaigre (CBG), cannabigerol acid (CBGA), delta-9- tetrahydrocannabivarin (THVC), cannabidivarin (CBDV)
• Determination of Moisture by Loss on Drying in Vacuum Oven and Karl Fisher
• Mycotoxin Analyses: Aflatoxins and Ochratoxin A
• Heavy Metals: Cadmium, Mercury, Lead, Arsenic, Niquel and Zinc • Total Ash and Sulfuric Ash • Analyses of pesticides: multiresidue pesticides • Terpene profile. MICROBIOLOGICAL ANALYSES • Mold and Yeast (TYMC) • Total Aerobes (TAMC) • Enterobacteria, Pseudomonas aeruginosa, Staphyloccoccus aureus, Escherichia coli, Salmonella spp, Shigella spp, Listeria Monocytogene
Validation of the irradiation process
Joint service provided in partnership with
Ionisos Ibérica*, where Ionisos performs
the irradiation of the samples and Linneo
performs the analyses, offering a unique
combined service
* Ionisos Ibérica is a company specialized is the irradiation of Cannabis flowers. Ionisos and Linneo have a partnership to provide combined solutions for irradiation and analytical services. Linneo and Ionisos are fully independent companies.
* Ionisos Ibérica is a company specialized is the irradiation of Cannabis flowers. Ionisos and Linneo have a partnership to provide combined solutions for irradiation and analytical services. Linneo and Ionisos are fully independent companies.
We will provide a final
report and coordinate the logistic of the
samples between both companies
Elaboration of the AMRad* dossier
Linneo will assemble the registration dossier
with the complete documentation, following
the mandatory eCTD format.
* Regulation on medicinal products treated with ionizing radiation in Germany.
* Regulation on medicinal products treated with ionizing radiation in Germany.
We will evaluate
the documentation available and assess what
documentation is needed, guiding the client
to complete the information
Ph. Eur. methods verified according to Chapter 5.26 Ph. Eur. In-house Analytical Methods validated according to ICH Q2(R2)
What makes us different
- Experienced and multidisciplinary team: our experience enables us to offer added value to our clients, contributing knowledge, expertise and resources from the beginning of the process through to registration and marketing.
- We have a specialized Quality and Regulatory Affairs unit, comprised of professionals with extensive experience in national and multinational companies in the pharmaceutical sector.
- We offer a complete service, including the coordination of the project between Linneo and Ionisos, including the transport of the samples between both companies, thus reducing logistics costs and bureaucracy. You will have a single interlocutor and a single contract.
- We work to maximize the potential of the collaboration: we share knowledge and benefits with our business partners to create a solid and fruitful relationship.
Certificates
For further information about how we can help, please contact