Biopharmaceutical Analysis

We answer readers’ top questions on limit of blank, limit of detection, limit of quantitation, acceptance criteria, and equivalence testing in analytical method validation.

CMC teams can align with Q5A(R2)’s updated guidance to shorten testing timelines and strengthen assurance of participant safety.

GSK will invest £400 million (US$532 million) in a new Cambridge, UK, R&D center, relocating from Stevenage amid second quarter earnings and a cost-savings plan.

Webinar Date/Time: Fri, Aug 21, 2026 11:00 AM EDT

Liquid chromatography and single-use chromatography platforms are reshaping biologics purification as the Asia-Pacific region challenges the dominance of North America and Europe.

Webinar Date/Time: Thu, Aug 6, 2026 11:00 AM EDT

Webinar Date/Time: Tue, Jun 30, 2026 11:00 AM EDT

AI adoption is no longer an abstract innovation exercise, but has become a critical lever for survival across the pharmaceutical landscape, characterized by compressed competitive windows and soaring development costs.

AI-driven protein design, continuous-learning R&D platforms, mechanistic PK/PD modeling, and automated analytical workflows are now foundational tools reshaping how biopharmaceuticals are discovered, characterized, and delivered.

Agilent’s Dr. Ganesh Bala explains how MAM-based LC–MS peptide mapping has become a foundational analytical tool for ADC and bioconjugate CQA monitoring in this Q&A piece.

Webinar Date/Time: Tue, Jun 23, 2026 11:00 AM EDT

Biopharma in 2026 advances decentralized manufacturing, AAV automation, QC modernization, and APAC clinical trial strategy.

Webinar Date/Time: Wed, Jun 24, 2026 11:00 AM EDT

Webinar Date/Time: June 18th, 2026, 11:00am ET

Webinar Date/Time: Tue, Jun 16, 2026 11:00 AM EDT

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.

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.

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.

For ATMP developers, the greatest barrier to commercialization is often not scientific discovery or funding, but the challenge of translating research-stage processes into reproducible, GMP-compliant manufacturing without compromising the therapy itself.

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.