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Zylidac Bio与Prolific Machines合作将光控细胞系平台放大至GMP生产

Zylidac Bio to Scale Prolific's Optogenetic Cell Line Platform to GMP

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Zylidac Bio与Prolific Machines于2026年10月21日宣布合作,将Prolific的光控细胞系开发平台从早期开发放大至GMP生产。该平台在15天CHO补料分批小规模运行中报告21 g/L单抗滴度,放大路径为先50 L技术转移、再250 L、后至GMP规模,目标多特异性抗体、融合蛋白和细胞因子。双方未披露财务条款及完成时间表,21 g/L结果尚未在生产规模重现。

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Zylidac will test whether optogenetic cell lines that hit 21 g/L in small-scale CHO runs can deliver higher-yield complex biologics at GMP scale.

Zylidac Bio, a biologics contract development and manufacturing organization (CDMO) within the Zydus Lifesciences group, and Prolific Machines announced a partnership on October 21, 2026, to scale Prolific's light-controlled cell line development platform from early development to good manufacturing practice (GMP) production.1 Both companies are headquartered in Emeryville, California.1

Key facts

  • Companies: Zylidac Bio (Zydus Lifesciences) and Prolific Machines
  • Agreement: Partnership to scale Prolific's platform to GMP production
  • Technology: Optogenetics-enabled, light-controlled protein expression in engineered cell lines
  • Reported productivity: 21 g/L mAb titer in a 15-day CHO fed-batch run (small scale)
  • Scale-up path: 50-L tech transfer, then 250 L, then GMP scale
  • Target modalities: Multispecific antibodies, fusion proteins, cytokines
  • Location: Emeryville, California (both companies)
  • Zylidac facility: 83,000 square feet; former Agenus site
  • Financial terms: Not disclosed

"After demonstrating success at development scale with industry-leading yields across mAbs and difficult-to-express proteins, the next step is scaling the technology to GMP production for clinical and commercial supply," said Deniz Kent, PhD, CEO and cofounder of Prolific, in a company press release.1 "We are very pleased to partner with Zylidac, with a proven team and a great new facility in immediate proximity to our labs in Emeryville. Our science and production teams can work on the same program in the same week, and our clients get a manufacturing partner that already knows the technology."

How does Prolific's platform work?

Prolific's technology uses light to control protein expression in engineered cell lines. The platform combines optogenetics-enabled cell lines, illumination systems compatible with standard bioreactors, artificial intelligence–driven process optimization, and analytics.1 The companies said the approach is particularly suited to difficult-to-express proteins, including multispecific antibodies, fusion proteins, and cytokines.1

Prolific has reported a productivity of 21 g/L in a 15-day intensified fed-batch Chinese hamster ovary (CHO) cell run for a monoclonal antibody at small scale, along with up to 3-fold titer increases for other complex formats.1

What will the scale-up involve?

Under the agreement, Zylidac will first complete a technology transfer of Prolific's process at 50-L scale to reproduce Prolific's results at the Zylidac site. The companies then plan to scale client programs to 250 L and into GMP manufacturing scale.1 According to the companies, Prolific's illumination hardware is designed to work with Zylidac's existing bioreactors, so customers would not need to build new manufacturing infrastructure.1

The partnership is intended to give Prolific's clients a single pathway. Cell line development begins at Prolific, and programs then move to Zylidac for scale-up, drug substance and drug product manufacturing, fill-finish, and packaging.1

"Prolific focuses on early-stage cell line development work, while we offer the process development, scale-up and GMP capacity required for later stages, including programs based on new expression technology like Prolific's," said Steve Lavezoli, chief commercial officer of Zylidac. "We built our Emeryville site to take a molecule from cell line to finished product."1

How did Zylidac enter the CDMO market?

Zydus completed its acquisition of Agenus' biologics manufacturing facilities in Emeryville and Berkeley, California, on January 15, 2026. It placed the assets in a newly formed US subsidiary, Zylidac Bio LLC, to offer CDMO services globally.2 Under the $141 million collaboration, Zydus paid Agenus $75 million upfront for the facilities, purchased $16 million of Agenus stock, and agreed to up to $50 million in contingent milestones. Those milestones are tied to production orders for Agenus' botensilimab and balstilimab combination.3 Zylidac's Emeryville facility spans 83,000 square feet, and the company reports that its team has conducted more than 40 cell bank programs and advanced more than 30 molecules into the clinic.1

What are the limitations?

The companies did not disclose financial terms of the partnership or a timeline for completing the 50-L technology transfer or reaching GMP scale. The 21 g/L titer was achieved at small scale and has not yet been reproduced at manufacturing scale; the tech transfer is designed to test whether those results hold at Zylidac's site. The release did not name any client programs that will use the pathway.

References

  1. Zylidac Bio. Zylidac Bio and Prolific Machines partner to scale Prolific's next-generation biologics manufacturing platform to GMP production. Press release. Published October 21, 2026. Accessed October 22, 2026. https://zylidacbio.com/insights/zylidac-bio-prolific-machines-partnership-gmp-production/
  2. Zydus Lifesciences. Zydus Lifesciences Limited completes the acquisition of Agenus Inc.'s biologics manufacturing facilities, launches Zylidac Bio LLC in the US Stock exchange filing. Published January 15, 2026. Accessed October 22, 2026. https://bsmedia.business-standard.com/_media/bs/data/announcements/bse/15012026/e1a9748f-cf01-476b-aad5-d9a773a09fb6.pdf
  3. Agenus. Agenus announces closing of $141M strategic collaboration with Zydus Lifesciences to advance BOT+BAL and strengthen US manufacturing readiness. Press release. Published January 15, 2026. Accessed October 22, 2026. https://www.agenusbio.com/press/Agenus-Announces-Closing-of-141M-Strategic-Collaboration-with-Zydus-Lifesciences-to-Advance-BOTBAL-and-Strengthen-U-S--Manufacturing-Readiness-8b0ce

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来源:BioPharm International · biopharminternational.com