Celltrion’s Dr. Juby Jacob-Nara discussed how subcutaneous infliximab may improve convenience, adherence, and sustained remission for patients with inflammatory bowel disease, while reducing reliance on infusion centers and supporting broader patient-centered treatment goals.
Subcutaneous infliximab may help improve treatment convenience, dosing consistency, and long-term adherence for patients with inflammatory bowel disease, according to discussions at DDW 2026. Clinicians highlighted the potential for self-administered infliximab to support sustained remission while reducing infusion-center burden and improving patient-centered care.
Circio CEO Erik Wiklund discussed how circular RNA technology may improve the safety, durability, and cost-efficiency of AAV gene therapies for cardiovascular diseases at ASGCT 2026. Early animal data suggest the platform reduces cellular stress responses while increasing gene expression, potentially expanding access to safer and more scalable gene therapy treatments.
Dr. Edwin Stone, CEO of Cellular Origins, emphasizes that scalable manufacturing must support, not limit, development of safe and effective biological therapies like cell therapies while speaking at the 2026 ASGCT Annual Meeting.
Erik Wiklund discusses how circular RNA-based AAV expression systems may improve gene therapy durability, reduce toxicity, and lower dosing requirements for next-generation therapies.
Vibha Jawa, PhD, discussed evolving approaches to preclinical development, animal use reduction, and immunogenicity assessment during an interview with BioPharm International at AAPS NBC 2026.
Cell therapy developers are prioritizing scalable manufacturing strategies alongside efficacy to support broader commercial deployment, notes Cellular Origins CEO Dr. Edwin Stone at the 2026 ASGCT Annual Meeting.
Preclinical ASGCT 2026 data suggest JCR Pharmaceuticals’ JUST-AAV platform may improve central nervous system delivery while reducing liver exposure in AAV-based gene therapies for rare neurodegenerative diseases.
Integra Therapeutics is advancing its FICAT gene writing platform to enable more sophisticated CAR T-cell engineering, combining CRISPR precision with high-capacity DNA integration for next-generation cancer therapies.
A new European Union regulatory framework known as MIDBA may streamline auto-injector approvals for biologics by reducing the need for repetitive pharmacokinetic (PK) bridging studies. Charles Theuer discussed how the model-based approach could accelerate drug-device combination development and potentially influence future FDA policy.
At AAPS NPC 2026, Charles Theuer discussed how converting biologics from intravenous (IV) infusion to subcutaneous (sub-q) administration is reshaping patient experience, safety profiles, and regulatory development strategies. The shift toward pharmacokinetic (PK)-based approvals and label extrapolation is enabling faster development of subcutaneous oncology and biologic therapies.
Emerging sequential treatment study designs may simplify and accelerate IV-to-subcutaneous biologic conversions by reducing variability and shrinking clinical trial sizes. Charles Theuer discussed how streamlined pharmacokinetic (PK)-driven regulatory pathways and evolving EU initiatives are reshaping subcutaneous biologic development.
Certara UK’s Dr. Armin Sepp, who spoke at the 2026 AAPS National Biotechnology Conference, explains how quantitative systems pharmacology may improve CAR T-cell safety and efficacy by modeling immune activation, tumor response, and cell persistence.
Yelena Ionova, Pharm.D., Redica Systems, discusses how benchmarking inspection data, strengthening sterile manufacturing controls, and adopting continuous regulatory intelligence strategies can help cell and gene therapy manufacturers improve inspection readiness and quality system performance.
Yelena Ionova, Pharm.D., Redica Systems, described how FDA and EMA standards for cell and gene therapy chemistry, manufacturing, and controls are increasingly aligned, yet manufacturers continue to struggle with basic GMP elements such as quality oversight, sterile processing, and staff training. She emphasized that newer CGT facilities have a critical opportunity to design quality systems and data integrity controls correctly from the outset to avoid costly remediation later.
Multi-attribute LC–MS methods improve characterization of complex bioconjugates, supporting scalable and regulatory-ready biotherapeutic development, says Agilent Technologies’ Dr. Ganesh Bala, who spoke at the 2026 AAPS National Biotechnology Conference.
The opening plenary session at this year’s AAPS National Biotechnology Conference will spotlight AI and NAMs as tools that advance predictive toxicology and human-relevant models to improve drug safety and translational research.
Ensorcell has entered the cell and gene therapy manufacturing market with its VersaWeld sterile tube welding platform, unveiled at INTERPHEX 2026 where it also won Best New Product/Service.
Highlights at INTERPHEX 2026 include digital integration and supply chain innovation to improve scalability, resilience, and efficiency in biomanufacturing.
As the biopharmaceutical industry moves increasingly toward applied AI in GMP manufacturing, emphasizing real-world use, PDA Week 2026 is expected to evolve as it further dives into risk management and data-driven quality decisions.
In the second half of an interview at the close of INTERPHEX 2026, Avantor’s Jerry Keybl explains that digital integration and AI-driven analytics enable predictive bioprocess control and can thus improve consistency, scalability, and data-driven manufacturing decisions.
Consistent fluid management across scales supports efficient bioproduction and reduces risk during scale-up of complex therapeutic modalities, says Avantor’s Jerry Keybl at INTERPHEX 2026.
AI and automation may streamline cell and gene therapy manufacturing by reducing labor demands while improving efficiency and supporting scalable production, says Dr. Alan Smith of Charles River Laboratories.
Dr. Alan Smith of Charles River Laboratories explains why early manufacturing planning and scalable processes are critical to ensure successful commercialization of complex cell and gene therapies as part of his panel discussion at INTERPHEX 2026.
ADC cleaning validation requires risk-based strategies to manage degradation and ensure safe limits for highly potent, dual-modality therapeutics, says Paul Lopolito, STERIS’ director of Technical Services, at INTERPHEX 2026.
At PDA Week this year, industry leaders highlighted the shift to applied AI in bio/pharma manufacturing and quality and compliance, while focusing on real-world implementation, say Kate Malachowski, PhD, and Malav Parikh, the co-chairs of PDA Week 2026, as they share their insights from the event.
Recapping this year’s PDA Week, Kate Malachowski, PhD, and Malav Parikh, the co-chairs of PDA Week 2026, share their insights on how AI and knowledge management are shaping the future of bio/pharma quality.
In the final part of the interview, Franco Negron, CEO, Simtra BioPharma Solutions notes the question frequently heard from sponsors and predicts where the CDMO market is heading.
In the second part of the interview, Franco Negron, CEO, Simtra BioPharma Solutions discusses the decision between insourcing manufacturing or partnering with a CDMO.
Franco Negron, CEO, Simtra BioPharma Solutions touches on rising demand for biologics and high-potency therapies and how driving early, large-scale investment in injectable manufacturing capacity keeps pace with market growth.
