Manufacturing, Biologics

Kenai Therapeutics has completed enrollment in the Phase 1b/2a REPLACE trial of RNDP-001, an allogeneic iPSC-derived dopaminergic neuron replacement therapy for idiopathic Parkinson's disease, with safety and preliminary efficacy data expected in 2027 — representing a significant step toward a potential disease-modifying cell therapy for a condition affecting more than 10 million people worldwide.

92Bio, Inc. has dosed the first patient in a Phase 1 trial of NTB-928, a fully human bispecific T-cell engager targeting FOLR1 and CD3, designed to selectively kill FOLR1-overexpressing ovarian cancer cells while sparing normal tissue — addressing a key limitation of prior FOLR1-directed therapies in platinum-resistant ovarian cancer.

The European Investment Bank-backed investment establishes a new single-use GMP facility with which Icosagen can support complex protein therapeutics from early discovery through phase 1/2 clinical manufacturing.

During an interview with BioPharm International, Cencora experts Andrea Zobel, senior manager of dangerous goods, and Marco Hogenboom, senior director of specialty logistics, highlighted the unique regulatory, logistical, and educational challenges associated with delivering radiopharmaceutical therapies to patients worldwide.

Andrea Zobel and Marco Hogenboom of Cencora World Courier discuss how advances in radiopharmaceutical manufacturing, cancer biology, and specialty logistics are enabling the expansion of targeted radiopharmaceutical therapies into larger patient populations and broader oncology indications.

According to Eli Lilly and Company, the extended dosing interval reduces maintenance injections to as few as 6 per year without required topical corticosteroids.

Point-of-care manufacturing could expand personalized medicine by enabling faster, decentralized drug production, though quality and regulatory hurdles remain.

Risk-based ADC cleaning validation must integrate degradation profiling, HBEL-aligned analytical methods, and dual large/small molecule strategies for facility safety, according to STERIS technical services director, Paul Lopolito.

AI and PAT have been shown to reduce manufacturing variability in advanced therapies, which leads to improved process control and accelerated patient access to lifesaving treatments.

With the closing of an acquisition, ROIS adds high-potent fill/finish and lyophilization capabilities to support biologics and ADC pipelines, addressing global supply and scalability challenges.

While allowing for high throughput and efficiency, the bulk fill/finish process exerts extreme stress on glass containers, resulting in cosmetic defects and breakage.

Trust-based CDMO partnerships are becoming essential to accelerate injectable drug development, manage risk, and ensure resilient biopharma supply.

Carrie Mason with Lonza Integrated Biologics discusses how PAT and AI are transforming biomanufacturing with predictive, integrated bioprocessing that speeds complex biologics through to clinic.

The company’s major long-term capital commitment highlights how global drugmakers are anchoring future innovation, advanced modalities, and supply resilience within China’s life sciences ecosystem.

Johnson & Johnson reinforces its long-term domestic investment strategy with a new $2 billion biologics facility in Wilson, North Carolina, further elevating the state’s role as a global life sciences hub.

Biomanufacturing is shifting toward more resilient and digitized networks for enhanced supply security amid global and supply-chain volatility.

Samsung Biologics’ Maryland acquisition signals a major push into US biologics manufacturing, reshaping the company’s capacity strategy and supply chain resilience.

This past year in biologics was marked by clinical trends, manufacturing scalability, and regulatory acceleration for antibody therapeutics.

The new collaboration will aim to streamline formulation-to-manufacturing workflows and de-risk development.

AstraZeneca’s $2 billion investment in its Maryland facilities will expand domestic biologics and rare disease manufacturing and strengthen US drug supply chains.

Abzena’s antibody platform enables Orion to streamline biologics development, showcasing trends in scalable, risk-reduced manufacturing for the industry.

Cellevate’s nanofiber technology enables higher viral vaccine titers in adherent cell cultures, advancing efficiency in large-scale biomanufacturing.

Optimizing FDA 483 responses with strategic CAPA creates resilient quality compliance in biopharma manufacturing.

Avantor's Jerry Keybl, senior vice-president, Biopharma Products and Strategy, highlights innovations in biomanufacturing and recalls his impressions of INTERPHEX 2025, held this past April.

Advanced technology platforms optimize the efficiencies and sustainability of single-use bioreactors, setting the scene for the next evolutionary step in biomanufacturing.