The agreement, which covers a period of five years, has been designed to offer a turnkey service to companies seeking faster time to market for ADCs and bioconjugates.
Darmstadt, Germany - November 10, 2021: A building at the headquarters of science and technology company Merck KGaA. | Image Credit: © Anne Czichos - stock.adobe.com
The sterile injectables contract development and manufacturing organization Simtra BioPharma Solutions, of Bloomington, Ind. in the United States, has announced a strategic alliance with the Life Science division of Merck KGaA, Darmstadt, Germany—which is known as MilliporeSigma in the US and Canada—to assist companies in the biopharmaceutical industry seeking solutions related to antibody-drug conjugates (ADCs) and bioconjugates, including linker and payload manufacturing, drug product formulation development, and fill/finish services (1).
As a press release from Simtra explained, the manufacture of an ADC is a complex process that involves combining a monoclonal antibody, cytotoxic payload, and linker into one stable and effective therapeutic (1). The development and contract manufacturing value chain created by this new partnership ties bulk drug substance made by MilliporeSigma together with Simtra’s drug product fill/finish capabilities. Dedicated product managers at each of the partners’ sites will be available to expedite customer needs and requests.
“By bringing together two experts in the ADC value chain, biopharmaceutical companies should benefit from shorter timelines and less complexity, allowing them to focus their efforts on drug discovery,” said Franco Negron, CEO of Simtra BioPharma Solutions, in the press release (1). “Harmonizing our processes with designated program management from start to finish will give customers greater confidence that their product will be delivered on time and to the highest quality standards—ultimately accelerating the delivery of life-changing therapies to patients who need them most.”
According to the press release, the ADC pipeline has been growing in recent years, driven by early successes against diseases such as human epidermal growth factor receptor 2 (HER2)-positive breast cancer; currently, 70% of these drugs are manufactured by CDMOs (1). A study by Roots Analysis values the ADC manufacturing market at $1.79 billion right now, but projects it to reach $7 billion by 2035 given a compound annual growth rate of 13%.
“Patients can’t wait. With over 200 new ADCs in active clinical trials, it is critical that we work to speed up the manufacturing process, reduce the risk of knowledge or time-loss during handoffs, and enable our clients to advance their programs,” said Benjamin Hein, head of Life Science Services, Life Science business of Merck KGaA, in the release (1). “Connecting the bioconjugation and fill/finish steps will be a value-add for our clients, ultimately meeting their ambitious timelines and allowing the broadest number of patients to benefit in the fastest and safest possible way.”
Just one day before the June 11 partnership announcement, Merck KGaA said that China’s Center for Drug Evaluation of its National Medical Products Association (NMPA) had accepted the company’s application for marketing authorization for pimicotinib, a novel, orally administered small-molecule inhibitor of the colony stimulating factor 1 receptor, or CSF-1R, for treatment of adult patients with tenosynovial giant cell tumors (TGCTs) requiring systemic treatment (2).
And in March 2025, Simtra head of Development Services Lidia Serina, PhD, spoke with Pharmaceutical Technology® Group at the Drug, Chemical & Associated Technologies Association (DCAT) Week 2025 about the key challenges in aseptic processing for sterile injectables. Click here to view that interview in its entirety.
1. Simtra BioPharma Solutions. Simtra BioPharma Solutions and MilliporeSigma Announce Strategic Alliance for Antibody Drug Conjugates Drug Substance and Drug Product Manufacturing Services. Press Release. June 11, 2025.
2. Merck KGaA. China’s Center for Drug Evaluation Accepts Merck KGaA, Darmstadt, Germany’s Application for Marketing Authorization of Pimicotinib for Treatment of Tenosynovial Giant Cell Tumor. Press Release. June 10, 2025.
3. Mirasol, F. DCAT Week 2025: Maintaining Aseptic Integrity and Stability in Sterile Injectable Manufacturing. BioPharmInternational.com, March 18, 2025.
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