PharmaLegacy Laboratories was founded in 2008 as a preclinical Contract Research Organization (CRO) providing specialty pharmacology services in Inflammation/Auto-Immune Diseases, Liver/Metabolic Diseases, Bone/Orthopaedics, and Oncology. The core competency of PharmaLegacy stems from our pioneering work and expertise in developing and running specialized animal disease models to test drug candidates and medical devices for their pharmacological effects and biocompatible repairs. Our animal disease models cover a wide range of species from rodents to Non Human Primates (NHP). Our unique NHP disease models form one of the key strengths of our services. We also conduct adjacency studies in PK/PD, molecular pharmacology and preliminary toxicology. Overall we provide one-stop shopping of preclinical pharmacology services from early proof of concept of therapeutics to fulfillment of regulatory requirements.
PharmaLegacy provides quality services with faster turnaround and higher productivity of R&D to IND/IDE endeavors for pharmaceutical, biotech, and orthopaedic device companies around the world.
Backed by a US private equity investment firm, PharmaLegacy is strategically located in the heart of the Biotech and Pharmaceutical base of Zhangjiang High Tech Industrial Park, Shanghai. We have a 45,000 ft2 facility with 17,000 ft2 of SPF and conventional vivarium which are accredited by AAALAC to house 10,000 rodents and 360 large animals.
TDAR to an antigen is a comprehensive immune function assay evaluating various aspects of immune responses, including antigen processing and presentation, B and T lymphocyte interactions, antibody production and cytokine-dependent isotype class switch (i.e., IgM to IgG specific antibody response).
The use of a TDAR assay is endorsed by regulatory agencies as a "default" immune function test for evaluation of the immuno-toxicity potential of new drug candidates.
TDAR is also employed to evaluate investigational drug efficacy in preclinical pharmacology studies, provide evidence of biological impact in clinical trials, and evaluate primary or secondary immunodeficiency diseases.
TDAR model in NHP provides a chance to overcome species specificity issue that biologics drug may have. NHP is also used in TDAR if it is deemed to be a more appropriate species for a particular small molecule (e.g., similarity of metabolism, better exposure, or immunity-related finding in standard toxicity studies only present in NHP).
The level of humanization (level of huCD45+ cells in peripheral blood) ranges between 40%-60% consistently. T cell immune-oncology checkpoint inhibitors PD-1 and PD-L1 antibodies (lead molecules from local R&D collaborators) demonstrated obvious inhibitory effects on the growth of HCC-827 human NSCLC cell line. PD-1 and PD-L1 antibodies stimulated the proliferation and differentiation of the human T cells in peripheral blood and accelerated the infiltration of human T cells into tumors.
GLP 10993 and CFDA 16886 Orthopedic Device Biocompatibility testing
We are able to assist with your IDE and 510(k) and SOP driven GLP quality assurance operations for your regulatory submission in the US, Europe and China.
For the 10993 and CFDA 16886 biocompatability testing prices are approximatly:
In-life study in rabbits (estimated at about @120 – 150 K USD)
The rest are at about $22,500 USD
Fulminant Hepatitis
Hepatitis B
Immune Response Related Hepatitis
Liver Steatosis
MCD:
Induced after 8 weeks of MCD diet, the animals developed inflammation with presence of steatosis, hepatocellular ballooning and minute amount of fibrosis.
CDA-HSD model, which is a modified version of MCD. It is based on a diet not completely methacholine deficient plus some high fat component. This model seems to be able to resolve the body lose problem of MCD model. The induction of this model last for 6-8 weeks.
AMLIN model, which is totally based on high fat diet. It takes 36 weeks to develop.
Obesity model in Monkeys
UUO Induced Kidney Fibrosis in Rats
Non-human primate (NHP) models have closer phylogenetic relationship to human and the disease targets in NHP models share high cross-reactivity to the human target specific biological molecules which do not react with rodent counterpart. PharmaLegacy has developed and validated serials of NHP disease models, covering Inflammation/Autoimmune Diseases, Bone/Orthopedics, and Respiratory disease areas, to test pharmacological effects and mechanisms of candidate drugs esp. therapeutic monoclonal antibodies.
NHP Animal Disease Models
Non-human primate (NHP) models have closer phylogenetic relationship to human and the disease targets in NHP models share high cross-reactivity to the human target specific biological molecules which do not react with rodent counterpart. PharmaLegacy has developed and validated serials of NHP disease models, covering Inflammation/Autoimmune Diseases, Bone/Orthopedics, and Respiratory disease areas, to test pharmacological effects and mechanisms of candidate drugs esp. therapeutic monoclonal antibodies.
NHP Animal Disease Models
NHP Inflammation Models:
NHP Asthma HDM Model
NHP Liver Fibrosis, BDL
NHP Colitis Model
DSS
Chemotherapy induced
NHP Rheumatoid Arthritis Models
Monkey CIA induced RA
Anemia
LPS induced Lung Injury
NHP DTH Models
TTx induced DTH
NHP Bone/Orthopedics Models:
OVX induced Osteoporosis
ACLT induced Osteoarthritis
Bone Healing
Bone Safety
Other NHP Models:
FeCl3 induced Thrombosis
Obesity
Oncology osteosarcoma
Bleomycin Induced Skin Fibrosis in Mice
◇Psoriasis-like inflammation
- IL-23-induced psoriasis-like inflammation in mice
- Imiquimod induced psoriasis-like inflammation in rats
◇Delayed Type Hypersensitivity (DTH)
- Oxazolone-induced DTH in mice
- DNFB-induced DTH in rats and mice
- Tetanus toxoid-induced DTH in monkeys
PharmaLegacy provides in vivo oncology models using more than 90 cell lines and tumor types in Humanized mice, syngeneic, Immuno-oncology, subcutaneous, orthotopic, and metastatic xenograft models. In addition, leukemia, lymphoma and myeloma models, and mouse syngeneic models are also available. We offer integrated and custom-tailored preclinical services, including but not limited to candidate screening, lead optimization, in vivo efficacy and biomarker validation in both small and large molecules’ drug discovery.
- >95 human tumor cell lines, >25 tumor types
- Subcutaneous, orthotopic and metastatic xenograft models
- Leukemia and lymphoma models
- Mouse syngeneic models and special tumor models
- Human primary tumor derived models
- Nude rate models, Combination chemotherapy & Radiation + treatment models
- Special focus: hepatocellular carcinoma (HCC), gastric cancer (GC), colon cancer, etc.
◇Colitis
- DSS-induced colitis in mice
- DSS-induced in monkeys
- DNBS-induced colitis in rats
- Chemotherapeutics induced colitis in rats and monkeys
PharmaLegacy offers the clients a broad spectrum of high quality services in the areas of in vitro ADME, in vivo pharmacokinetics and bioanalysis services, with cost-efficiency and fast turnaround. The test articles range from small molecules to large molecules, such as protein and antibody. The animal species involved are non-human primate, canine, mice, rat, rabbit, guinea pig and mini pig.
Bioanalysis
◇ Method Transfer, Development and Validation
- LC-MS/MS (small molecules, peptides and protein)
- ELISA (antibody)
- HPLC (small molecules and oligonucleotides)
◇ Biological Matrix
- Plasma, serum and blood
- Urine, feces and bile
- Tissues and tumor specimens
- Cerebrospinal fluid
◇ In Vivo Dosing
- Intravenous (bolus/infusion)
- Intra-duodenal, intra-portal
- Oral, subcutaneous, intraperitoneal, intramuscular, dermal plus other routes
◇ Outputs
- Sample concentrations
- PK parameters (WinNonLin)
◇ Services
- Bioavailability
- Single and multiple dose PK
- Crossover studies
- Cassette PK for compound screening
- Dose ranging and proportionality
- BBB penetration
- Drug distribution in tissues
- Excretion studies
- PK study for formulation/form development
- Exploratory non-GLP TK studies
- PK/PD study in animal disease models
- DMPK study for IND filing
◇Cartilage Tissue Repair
•Intervertebral disc repair
•Intra-articular particulate injection
•Meniscectomy and ACL transection
•Osteochondral defect
•Pond Nuki model
◇Passive Cutaneous Anaphylaxis (PCA)
- PCA in rats and mice
FeCl3 Induced Arterial Thrombosis on Monkey
◇Osteomyelitis
•Pyogen-induced and wear debris induced in rats, rabbits and dogs
◇Experimental Autoimmune Neuritis (EAN)
- SP-26-induced EAN in rats
Gouty Arthritis
◇Radioprotective activity in rats and mice
Integrated Drug Evaluation
- Cell-based Assays
- Clinical scoring
- Clinical Biochemical Analyzer
- Cytokine panel analysis
- Complete blood count (CBC)
- PK/PD Studies
- Immunohistochemistry/Histopathology
◇Graft-Versus-Host Disease (GVHD)
- Allobone marrow transplantation induced acute GVHD in mice
System Lupus Erythematosus (SLE)
PharmaLegacy offes non-GLP preclinical toxicological studies in various animal species.
Single and repeated dose toxicity study (rodent and non-rodent)
LD50 study
MTD study
Dose escalation study
7-day and 14-day DRF study
1-month to 9-month sub-chronic and chronic toxicity study
Immunogenicity study
Toxicokinetics study (rodent and non-rodent)
Topical toxicity study
◇Cough
• Citric acid-induced cough in guinea pigs
◇Ligament/Tendon
•Achilles', ACL, patella and rotator cuff segmental defect repair in dogs and sheep/goats
◇Bone Repair
•Bone void filler testing in rats, rabbits, mini-pigs, dogs and primates
•Calvarial, periodontal and long bone
•Spine fusion in rats, rabbits and primates
Bone Loss/Osteoporosis
•Rats, mice, dogs, monkeys and rabbits
- Estrogen-deficiency
- Steroid-induced
- Disuse
•Local injection to calvaria and long bone
◇Liver Injury Regeneration
◇Comedones
- Oleic acid-induced comedones in rabbits
◇Experimental Autoimmune Uveoretinitis (EAU)
- Bovine IRBP R16-induced EAU in rats
Drug Discovery & Development Services
Biology Services
Pharmacology Services
In vivo ADME/DMPK Studies Services
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