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Developments in biotech:
recombinant medications in fertility

As in other fields of medicine, developments in biotechnology have had a significant impact on fertility care.1,2 Genetic engineering and recombinant DNA technology paved the way for industrial-scale production of complex protein molecules.2 Prior to this breakthrough, human donors were a major source of hormonal fertility treatments.3,4 Today, recombinant technology expands therapeutic options.5

An evolution to a single manufacturing method

The purification process

In 1950, EMD Serono developed the first human menopausal gonadotropin (hMG), which was derived from donor urine.4 (This product is no longer on the market.) Over time, the company continued to refine and enhance its production methods for hMG. In devising techniques to improve the purification process, researchers discovered that the extraction steps used to filter the pooled donor urine inadvertently removed most of the LH.6 This situation was addressed by adding hCG from pregnant donors’ urine to provide LH-like activity.6,7

Production considerations

Researchers identified challenges related to product purity, consistency, chemical oxidation, and reliance on donors. In addition, concerns emerged about the theoretical risk of infection and about product traceability if an infection did occur.1,4,6,8-12

The transition 

Based on these considerations, the company’s fertility division opted to focus on recombinant products.

Characteristics of recombinant and urinary medications

When prescribed as part of a fertility treatment, outcomes are generally comparable for recombinant and urinary medications.1

Recombinant medications
  • Purity: recombinant production within sterile biotechnology facilities allows for a high degree of product purity and a low risk of infection.13,14
  • Consistency: recombinant gonadotropin dosing is based on direct measurement of the active ingredient—a method described as, “filled by mass.” 4,6
  • Chemical stability: recombinant technology has led to advances in the stability of protein-based products.15
  • Production logistics: in an effort to improve efficiency, production methodologies continue to evolve towards single-use bioreactors—rather than dedicated facilities designed exclusively for a single medication.16

Urinary medications
  • Heritage and familiarity: urine-derived gonadotropins have been prescribed for decades, with well-documented efficacy and safety.17-18
  • Donor-derived: these are natural products, extracted from the urine of post-menopausal and/or pregnant women.18 Supply is dependent on donor resources.1
  • Oxidation: degrees of oxidation of drug products may affect biopotency.19
  • Consistency: batch-to-batch variability occurs in urinary-derived products based on the standardized allowable range in product manufacturing.4

Looking to the future

EMD Serono continues to invest in research and development to advance the field of fertility care and to improve the patient experience. Stay connected to the future of fertility.

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1. Child T et al. Front Endo. 2025;16:1536844 (1-14). 2. Bifulco M et al. EMBO Rep. 2025; 26;303-306. 3. Ebrahimi SB et al. Nat Comm. 2023;14:2411. 4. Lunenfeld B et al. Fertil Steril. 2018;110:255–263. 5. Racca A et al. Drugs. 2020;80(10):973-994. 6. Lunenfeld B et al. Front Endocrinol. 2019;10:429 (1-14) 7. Capolupo A et al. Int J Mol Sci. 2024;25:9405. 8. Ezcurra D et al. Reprod Bio Endo. 2014;12:95. 9. Van de Weijer BHM et al. Reprod Biomed Online. 2003:7(5):547–557. 10. Casarini L et al. Endo Rev. 2018;39:549-592. 11. Bassett R et al. Reprod Biomed Online. 2009;19:300–313. 12. Leão B et al. Clinics. 2014;69:279–293. 13. Landgraf W et al. Eur Endo. 2015;12(1):1-6. 14. Liras A. Int Arch Med. 2008;1:4. 15. Jayakrishnan A et al. Sci. 2024;6:9 (1-24). 16. Jacquemart R et al. Comp Struct Biotech J. 2018;14:309-318. 17. Patki A et al. J Hum Repro Sci. 2018;11(2):1-6. 18. Anderson RC et al. Endo Rev. 2018;39:911-937. 19. Nevelli F et al. Int J Mol Sci. 2023;24:8040.

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