Fertility Preclinical CRO Services

Worldwide, fertility rates have declined by nearly 50% over the last 50 years. In the United States of America, nearly 19% of heterosexual women younger than the age of 50 were diagnosed as infertile after a year of trying to conceive. To combat the decline in fertility rates and the increased desire to conceive, the infertility drug market may see profits of nearly $3.50 Billion USD in 2022.

The most prescribed fertility drugs were developed by companies such as Bayer, Berlex Laboratories Inc., Janssen Pharmaceuticals, Merck & Co. Inc., Pfizer Inc., F. Hoffmann-La Roche AG, Ferring Pharmaceuticals, and more. While smaller companies may lead the charge in research & development for novel fertility drugs and devices. With nearly $350 million invested into fertility startups in the last year. Where does your company stand in its current phase of product development?

At AniLocus, we are a full-service multispecialty preclinical CRO that utilizes state-of the art technologies to validate fertility drugs and devices. We conduct IDE and IND-enabling studies for drug-target interactions, molecular mechanistic pathways, efficacy, safety, toxicology, and tumorigenicity. Customizing our preclinical approach to fit your company trajectory towards FDA approval.

Preclinical Contract Services for Fertility Drug & Device Development:

Assisted Reproductive Technology Development
Conception Device Development
Congenital Reproductive Disorders
Contraceptive Device Development
Developmental & Reproductive Toxicology (DART)
Dietary Supplement Testing for Fertility Treatment
Epigenetic Transgenerational Inheritance
Erectile Dysfunction
Extended One-Generation Reproductive Toxicity Studies
Female Infertility Animal Modeling
Female Sexual Arousal Disorders
Fertility Preservation Studies
Immunohistochemistry
Male Infertility Animal Modeling
Multiplex Hormonal Panels
Oocyte Retrieval
Ovarian Culture
Ovulation Induction Studies
Posthumous Sperm Retrieval Studies
Rare Reproductive Disease Modeling
Reproductive Endocrinology/Neuroendocrinology
Sexual Function & Behavioral Analysis
Spatial transcriptomics
Sperm & Semen Storage Banking
Sperm Analysis
Transcriptomic Target Research
Transgenic Animal Development
Learn more: Our Services

How Can AniLocus Help You?

We are experienced in the design and execution of NDA-enabling and IND-enabling preclinical studies for efficacy, safety, in vivo pharmacology, pharmacokinetics (PK), pharmacodynamics (PD), ADME (absorption, distribution, metabolism, and excretion), toxicology, local tolerance–Learn more!

Preclinical Models

Multiple animal models are used in fertility preclinical research including:

Gene knockout/knockin/trapped
Transgenic rodents
Chemically-Induced Point Mutation rodents
Stress-induced models
Drug-Induced models
Metabolically-induced models (Diet-induced, Metabolic disorder, micronutrient deficient)
And more…

We conduct translational animal studies (in vivo and in vitro) collecting detailed, comprehensive results with rapid turnaround.

Drug Modalities

Drug modalities are different types of therapeutic agents. Each drug is a customizable tool designed for therapeutic intervention. The question is…does your product work and is it safe?

At AniLocus, we conduct relevant preclinical studies to assess any drug modality:

Antibodies (nanobodies, monoclonal)
Gene therapy (CRISPR, TALEN)
Viral therapy (adenovirus-AAV, lentivirus)
Oligo- and polypeptides (e.g., stapled and modified peptides)
Oligo- and polynucleotides (e.g., siRNAs, mRNAs, aptamers)
Polyglycosides
Macrocyclic molecules
Drug conjugates (e.g., antibody–drug conjugates, drug–drug conjugates, fluorescence-labeled drugs)
Targeted protein degraders (e.g., proteolysis-targeting chimeras (PROTACs) and molecular glues) that induce a chemical knockdown of proteins
Cellular therapies (stem cells, allogenic, autologous)

Interrogative Instruments & Assay Platforms

Using animal and human cells and tissue we can perform multiple interrogative assays depending on therapeutic area and sample type:

DNA: Extraction, PCR, ddPCR, qPCR, sequencing, genotyping
RNA: Gene expression profiling, RT-PCR, miRNA, Next-generation sequencing (Nanostring, Illumina), spatial transcriptomics, In situ hybridization (ISH), Multiplex ISH
Protein: Immunoassays (ELISA, EIA, Luminex), proteomics, ligand binding assays, protein expression, immunohistochemistry (IHC), immunocytochemistry (ICC), and immunofluorescence (IF)
And more!

Fertility Preclinical Literature Review

Sinha S, Knapp M, Pywtorak J, McCain G, Wingerden K, VanDervoort C, Gondek JM, Madrid P, Parman T, Gerrard S, Long JE, Blithe DL, Moss S, Lee MS. Contraceptive and Infertility Target DataBase: a contraceptive drug development tool for targeting and analysis of human reproductive specific tissues. Biol Reprod. 2021 Dec 20;105(6):1366-1374. doi: 10.1093/biolre/ioab172. PMID: 34514504; PMCID: PMC8831241.
Chen, S. R., Batool, A., Wang, Y. Q., Hao, X. X., Chang, C. S., Cheng, C. Y., & Liu, Y. X. (2016). The control of male fertility by spermatid-specific factors: searching for contraceptive targets from spermatozoon’s head to tail. Cell death & disease, 7(11), e2472. https://doi.org/10.1038/cddis.2016.344
Balbach M, Fushimi M, Huggins DJ, Steegborn C, Meinke PT, Levin LR, Buck J. Optimization of lead compounds into on-demand, nonhormonal contraceptives: leveraging a public-private drug discovery institute collaboration. Biol Reprod. 2020 Aug 4;103(2):176-182. doi: 10.1093/biolre/ioaa052. PMID: 32307523; PMCID: PMC7401349.
Landi, H. (2022). Fertility support startups banked $345M in 2021. Here’s why the business of family planning is booming. Fierce Healthcare.

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