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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!

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 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)

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!
  1. 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.
  2. 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.
  3. 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.
  4. 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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