We are a young pharmaceutical company focused on offering high-quality, viable, and accessible alternatives.
Biotechnology in service of life
We develop and evaluate biopharmaceutical proteins, monoclonal antibodies, and hormones for reproductive medicine, immunology, and immuno-oncology, with a specialization in recombinant proteins and research for the commercialization of biosimilars.
Building a world-class specialized pharmaceutical company
Pipeline
Description: Monoclonal antibodies and antibody-drug conjugates (ADCs) for selected oncology indications.
Status: Under evaluation for inclusion in the portfolio.
Description: Monoclonal antibodies for autoimmune and inflammatory diseases.
Status: Under evaluation / asset identification.
Description: Hormonal and biologic medicines used in reproductive medicine.
Status: Under regulatory and supply evaluation.
* Disclaimer: The information presented does not constitute a commercial offer or promotion of specific products and is subject to regulatory processes and confidentiality agreements.
Biosimilars
Quality, access, and sustainability
We believe biosimilars are essential to strengthen the sustainability of the healthcare system and enable broader access to biologic therapies.
At the core of our mission is a commitment to health: helping more people access high-quality, proven-safe therapeutic options while promoting cost savings and broader access to critical treatments for chronic and complex diseases.
What are biosimilar medicines?
Biosimilars are approved biologic medicines that are similar to already recognized biologic medicines (reference medicines) available on the market.
Benefits of biosimilars
Same therapeutic benefits:Designed to be administered at the same concentration, dose, and route as the reference medicine.
Safety supported by regulatory review: Studies must demonstrate that no new or worse side effects are expected compared to the original biologic.
Lower costs and greater savings:Increased competition may translate into more competitive pricing.
Greater access to treatments: More options available for patients.
Greater access to treatments: More options available for patients.
Therapeutic versatility:Use across various conditions, including chronic and complex diseases.
Monoclonal Antibody Therapies
Biotechnological platforms for precision medicine
At Starseed Pharma, we work with biologic therapeutic platforms designed to act on specific molecular targets (proteins or receptors). This approach supports more targeted interventions that are better aligned with each case’s biological profile.
These therapies are used when there is an identifiable target and a clinical indication that supports their use.
Monoclonal Antibody Therapies
Monoclonal antibodies (mAbs) represent one of the most significant advances in modern medicine. They are highly precise biologic drugs designed to mimic the immune system’s ability to fight pathogens and diseased cells.
mAbs play a central role in personalized medicine (also known as precision medicine) because they enable a shift from a “one-size-fits-all” approach to interventions tailored to each patient’s unique genetic and molecular characteristics. Thanks to their ability to bind to specific targets with high precision, they serve as tools that direct treatment toward diseased cells.
Unlike conventional treatments, mAbs are engineered to interact with specific molecular targets, such as genes or proteins that are essential for the growth and survival of certain diseases.
What are biosimilar medicines?
Biosimilars are approved biologic medicines that are similar to already recognized biologic medicines (reference medicines) available on the market.
Benefits of biosimilars
Same therapeutic benefits: Designed to be administered at the same concentration, dose, and route as the reference medicine.
Safety supported by regulatory review: Studies must demonstrate that no new or worse side effects are expected compared to the original biologic.
Lower costs and greater savings: Increased competition may translate into more competitive pricing.
Greater access to treatments: More options available for patients.
Therapeutic versatility: Use across various conditions, including chronic and complex diseases.
Monoclonal Antibody Therapies
Biotechnological platforms for precision medicine
At Starseed Pharma, we work with biologic therapeutic platforms designed to act on specific molecular targets (proteins or receptors). This approach supports more targeted interventions that are better aligned with each case’s biological profile.
These therapies are used when there is an identifiable target and a clinical indication that supports their use.
Monoclonal Antibody Therapies
Monoclonal antibodies (mAbs) represent one of the most significant advances in modern medicine. They are highly precise biologic drugs designed to mimic the immune system’s ability to fight pathogens and diseased cells.
mAbs play a central role in personalized medicine (also known as precision medicine) because they enable a shift from a “one-size-fits-all” approach to interventions tailored to each patient’s unique genetic and molecular characteristics. Thanks to their ability to bind to specific targets with high precision, they serve as tools that direct treatment toward diseased cells.
Unlike conventional treatments, mAbs are engineered to interact with specific molecular targets, such as genes or proteins that are essential for the growth and survival of certain diseases.
What are monoclonal antibodies?
They are laboratory-created proteins with a “Y-shaped” structure that allows them to bind to specific targets (antigens) with extremely high affinity. Unlike naturally occurring antibodies, monoclonal antibodies are identical copies produced to target a single molecular target, making them highly specific therapeutic and diagnostic tools.
History and origin: The birth of a revolution
The development of these drugs has followed a trajectory of key scientific milestones:
Background (1890–1897): Emil von Behring and Kitasato demonstrated the effectiveness of serum therapy, and Paul Ehrlich coined the term “antibody,” laying the foundations of immunology.
The major milestone (1975): Georges Köhler and César Milstein developed hybridoma technology by fusing B lymphocytes with myeloma cells to achieve continuous production of identical antibodies, work for which they received the Nobel Prize.
Technical evolution: Since their creation, mAbs have gone through four stages of engineering, from early murine (mouse-derived) antibodies to today’s fully human antibodies, reducing immunogenicity and improving effectiveness.
Clinical use (1986): The first monoclonal antibody (muromonab-CD3) was approved by the FDA in 1986, paving the way for more than 100 therapies approved to date.
Who are they indicated for?
These treatments are a pillar of personalized medicine. They are not administered broadly, but rather to patients whose biological profile presents the specific target that the antibody can recognize.
- They are used in patients with specific biomarkers (such as the HER2 protein in breast cancer or CD20 in certain lymphomas).
- They are indicated for individuals with chronic or infectious diseases where conventional therapies do not offer the level of precision needed to avoid damage to healthy tissues.
Main indications
Their versatility allows them to be used across several critical areas of health:
01
Oncology: They work by blocking tumor growth signals, tagging cancer cells so the immune system can destroy them, or delivering drugs directly to the tumor.
02
Autoimmune diseases: They are used to regulate excessive immune responses by binding to autoantigens or receptors on B cells, playing a key role in treatments within rheumatology and neurology.
03
Infectious diseases: They are vital for neutralizing viruses and bacteria, with recent use highlighted against COVID-19, respiratory syncytial virus (RSV), Ebola, and influenza.
04
Diagnostics: They are essential in laboratory tests such as ELISA for detecting hormones, viruses, and other biomarkers in the body.
Main diagnostic technologies
The use of these antibodies in medical settings is primarily implemented through two technologies:
- ELISA (Enzyme-Linked Immunosorbent Assay): Invented in 1971, this technique revolutionized diagnostics by enabling the identification and precise measurement of hormones and viruses through the specific binding between the antibody and its target.
- Immunofluorescence: Uses mAbs to label and visualize specific biomolecules under specialized equipment, enabling analysis of complex biological processes at the cellular level.
Advantages of using monoclonals in diagnostics
Specificity and uniformity: Thanks to hybridoma technology, it is possible to produce large quantities of antibodies that are chemically and structurally identical, ensuring diagnostic tests are consistent and accurate.
Precision tools: They function as “sensors” that can analyze individual biomolecules, significantly improving understanding of each patient’s biological processes.
How does prior diagnostic testing enable targeted and personalized therapies?
Prior diagnostic testing is the fundamental step in personalized and precision medicine, as it makes it possible to identify the unique genetic and molecular characteristics of a patient’s disease. Without this analysis, it would not be possible to select the appropriate drug that targets only the harmful cells.
Here’s how diagnostic testing supports these therapies:
- Identification of specific “targets”: Using diagnostic tools (which often rely on the same monoclonal antibodies in tests such as ELISA), physicians can detect biomarkers or proteins on the surface of diseased cells. These proteins act like an “address” that indicates where the medicine should act.
- Selection of the appropriate treatment: Once diagnostic testing confirms the presence of a specific target (antigen), a targeted therapy can be initiated.
• In oncology: if tests detect the HER2 protein in breast cancer, therapies specifically directed at that receptor may be used.
• In hematology: if the CD20 protein is identified, the use of drugs such as rituximab may be indicated.
- Personalized care: This allows a shift from a “one-size-fits-all” approach to an individualized one. By understanding the patient’s biological profile:
• The goal is to improve effectiveness by acting directly on the mechanism driving the disease.
• The goal is to reduce unnecessary side effects by avoiding intervention in healthy tissues that do not present the therapeutic target.
- Data integration: The use of detailed genetic and medical information allows researchers and clinicians to design combined strategies (such as immunotherapy or gene therapy) that better align with the individual’s needs.
*Disclaimer: The information presented is for informational and scientific purposes only. It does not constitute a commercial offer or promotion of specific products and is subject to regulatory processes, availability, and confidentiality agreements.
Bibliography
- 1. Kothari, M., Wanjari, A., Acharya, S., et al. (2024). A Comprehensive Review of Monoclonal Antibodies in Modern Medicine: Tracing the Evolution of a Revolutionary Therapeutic Approach. Cureus, 16(6), e61983. https://doi.org/10.7759/cureus.61983.
- 2. Carrasco-Yalán, A. (2021). Anticuerpos monoclonales en la práctica médica. Diagnóstico, 60(4), 187-188. https://doi.org/10.33734/ diagnostico.v60i4.320.
- 3. National Cancer Institute (2019). Monoclonal Antibodies. National Institutes of Health. https://www.cancer.gov/ aboutcancer/treatment/ types/immunotherapy/ monoclonal-antibodies.
- 4. Buss, N. A. P. S., Henderson, S. J., McFarlane, M., et al. (2012). Monoclonal antibody therapeutics: history and future. Current Opinion in Pharmacology, 12(5), 615-622. https://doi.org/10.1016/ j.coph.2012.08.001.
- 5. Cao, Q. (2024). The Application and Mechanism of Monoclonal Antibodies in Diseases. Highlights in Science, Engineering and Technology, 109, 6-12. https://doi.org/10.54097/ g4hf2552
Fertility Therapies
High-quality medicines to support your fertility
Infertility, according to the World Health Organization, is defined as not achieving a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse. It is estimated to affect approximately 10–15% of reproductive-age couples worldwide.
In assisted reproduction, pharmacological treatment is key to supporting stages such as ovulation induction, controlled ovarian stimulation, and In Vitro Fertilization (IVF) protocols.
At Starseed, our goal is to develop and evaluate infertility medicines with a clear focus: pharmaceutical quality, safety, and batch-to-batch consistency. We know that in hormonal therapies, manufacturing precision matters as much as the molecule itself.
Our approach to pharmaceutical quality
Manufacturing partner selection
Starseed is in the process of establishing partnerships with certified manufacturers, prioritizing:
- Production under internationally recognized Good Manufacturing Practices (GMP).
- Rigorous quality control for every batch.
- Traceability and regulatory compliance to support health authority approval.
- Stable formulations and consistent bioavailability.
Taken together, this approach aims to ensure that medicines brought to market are supported by reliable pharmaceutical standards.
What do we look for in infertility medicines?
The compounds Starseed develops or evaluates focus on supporting four clinical goals within assisted reproduction:
- Controlled ovarian stimulation
- Ovulation induction in cases of anovulation
- Regulation of the gonadotropic axis
- Luteal phase support
For each group, we prioritize:
- Raw materials with certified origin and pharmaceutical-grade purity.
- Manufacturing processes that reduce batch-to-batch variation.
- Proven stability throughout the product’s shelf life.
- Compliance with national and international regulations for marketing authorization.
Safety and confidence for prescribers and patients
Fertility treatments carry significant clinical and emotional responsibility. That is why portfolio development is guided by medicines that:
- Fit into evidence-based therapeutic protocols.
- Can be prescribed by specialists in human reproduction.
- Include pharmaceutical oversight and post-marketing monitoring.
Main medication groups in fertility care
1) Gonadotropins (FSH and LH)
Recombinant or urinary gonadotropins (FSH, hMG) stimulate follicular growth in the ovary. They are mainly used for:
• Controlled ovarian stimulation in IVF
• Ovulation induction in anovulation
• Poor ovarian response
These therapies support multifollicular development to optimize oocyte retrieval in assisted reproduction cycles.
2) GnRH analogs and antagonists
They regulate endogenous gonadotropin secretion and help prevent premature ovulation during IVF cycles.
Expected clinical benefits within the protocol:
• More precise cycle control
• Better synchronization for oocyte retrieval
• Reduced risk of ovarian hyperstimulation syndrome (OHSS)
3) Oral ovulation induction agents
Clomiphene citrate and letrozole are used in ovulatory dysfunction, especially in polycystic ovary syndrome (PCOS). Clinical evidence has positioned letrozole as a first-line option in PCOS due to higher pregnancy rates and a lower risk of multiple gestation.
4) Luteal phase support
Progesterone (micronized or in vaginal/intramuscular formulations) is a key component to:
• Maintain endometrial receptivity
• Support embryo implantation
• Reduce the risk of early pregnancy loss
Luteal support is considered standard in IVF cycles according to international guidelines.
Our commitment to your reproductive health
Starseed strengthens its commitment to reproductive health through the development and structuring of an infertility medicine portfolio focused on certified manufacturing, pharmaceutical quality, and regulatory compliance. Our vision is to ensure products with therapeutic consistency, traceability, and scientific support, aligned with international best practices and recommendations from organizations such as ASRM and ESHRE.
*Disclaimer: The information presented is for informational and scientific purposes only. It does not constitute a commercial offer or promotion of specific products and is subject to regulatory processes, availability, and confidentiality agreements.
Bibliography
- World Health Organization. Infertility fact sheet.
- American Society for Reproductive Medicine Practice Committee Guidelines on Controlled Ovarian Stimulation.
- European Society of Human Reproduction and Embryology Ovarian Stimulation Guidelines (2020–2023 updates).
- Legro RS et al. Letrozole vs Clomiphene for infertility in PCOS. New England Journal of Medicine. 2014.
- Practice Committee of ASRM. Luteal phase support in assisted reproduction. Fertility and Sterility.
Who Are We?
We are a pharmaceutical company created with the purpose of developing and consolidating our own portfolio of biopharmaceutical medicines, focused on highly specialized therapeutic areas.
Our model is based on direct collaboration with developers, manufacturers, CDMOs, and technology holders to incorporate products into our portfolio and responsibly move them through regulatory and commercial stages.
We operate under a compliance framework aligned with current health regulations and international standards of quality, safety, and pharmacovigilance.
Focus areas
01
Oncology: We evaluate monoclonal antibodies and ADCs targeting selected indications, primarily in solid tumors and highly complex targeted therapies.
02
Immunology: We explore biologic assets for autoimmune and inflammatory diseases, with a focus on differentiated therapies and complex biosimilars.
03
Reproductive Medicine: We evaluate hormonal and biologic medicines used in fertility and assisted reproduction treatments, aimed at improving clinical outcomes and the patient experience.
Capabilities
We have internal capabilities and strategic partnerships that allow us to advance our own pharmaceutical projects across different development stages.
- Scientific and technical evaluation of biologic assets for portfolio inclusion.
- Regulatory feasibility assessment and registration strategy.
- Coordination with manufacturers, CDMOs, and technology partners.
- Quality management, documentation, and traceability.
- Implementation of pharmacovigilance systems.
- Preparation for institutional and specialized commercialization.
Quality and compliance
Quality and regulatory compliance are fundamental pillars of our operations. Our processes include:
- Good Manufacturing Practices (GMP).
- Quality management and document control.
- Supplier evaluation and qualification.
- Risk and deviation management.
- Regulatory and contractual compliance.
Strategic partnerships
We build long-term relationships with technology partners and manufacturers to incorporate medicines into our pharmaceutical portfolio.
We build partnerships to support development and access to specialized therapies. We believe the availability of biotechnological medicines requires strategic collaboration, technical rigor, and regulatory alignment.
We collaborate with:
- Developers of monoclonal antibodies and ADCs.
- Biotech companies with clinical-stage assets.
- Manufacturers and CDMOs specialized in biologics.
- Marketing authorization holders or technology owners.
Collaboration models
- Licensing for our own portfolio.
- Technology transfer.
- Supply of bulk drug substance or finished product.
- Development and registration agreements.
Pharmacovigilance
We have a pharmacovigilance system in accordance with NOM-220-SSA1-2016, focused on the detection, assessment, and reporting of adverse events associated with medicines under evaluation or commercialization.
Patient safety is a central pillar of our pharmaceutical strategy.
Contact
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