Feliza Mirasol

Samsung Life Science Fund’s investment in Phrontline Biopharma highlights growing industry momentum behind dual-payload ADCs.

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

Progress in vaccine development is closely tied to advancements in biopharmaceutical technologies, regulatory landscapes, and quality assurance methodologies.

News in the week shows biopharma development being redefined by programmable biology and accelerated FDA review, stressing quality compliance and market efficiency.

Regulators and manufacturers face new uncertainty as shifting CDC vaccine language raises concerns for evidence-based oversight and biopharma compliance.

Microfluidic rapid-testing advances enhance real-time QC, strengthen compliance, and speed contamination detection across modern biomanufacturing.

RxCelerate and Constructive Bio will combine programmable biology with integrated discovery tools to speed engineered biologics for hard-to-treat diseases.

The EC approves the world's first liquid IV infliximab biosimilar, which cuts preparation time by 51% and offers up to €2.6 million (US$3.0 million) in potential annual savings.

Biogen reports CHMP support for an enhanced nusinersen regimen, signaling potential shifts in SMA treatment strategies and global regulatory decisions.

Experts at AAPS PharmSci 360 discuss industry-wide transformation from AI implementation and the ripple effect on workforce development.

Eric Hill, Chief Scientific Officer, BA Sciences, discusses the how E&L testing principles can be adapted to biologic products and the unique challenges biologic drugs face regarding E&Ls.

This week’s biopharma news highlights formulation stability testing, automation in analytics, and achieving regulatory compliance.

Eric Hill, Chief Scientific Officer, BA Sciences, discusses the analytical challenges involved in conducting E&L testing for biologic drug products.

FDA’s newly introduced review route enables faster clearance of custom genetic and cell treatments, reshaping rare-disease development and manufacturing strategies.

Reliable bioanalysis and regulatory-compliant study design enhance drug development, says Alturas’s Sara Underwood at AAPS PharmSci 360.

The company demonstrates advances in glioma hydrogel, high-concentration biologics, and nanoencorafenib licensing, impacting drug delivery strategies.

At AAPS PharmSci 360, Kelly Donovan says tailored analytical strategies are necessary for reducing development delay risks.

At AAPS PharmSci 360, Ely Porter, PhD, says automated platforms enhance drug production velocity and assay excellence.

At AAPS PharmSci 360 2025, Siddhant Sojitra, Alexion, defines an agitation model to reliably test stability for early-stage biologics.

Financing strategies for new modalities and AI will be central at PharmSci 360, shaping how advanced therapeutics move toward global patient access.

Novel biologics, from ADCs to in-vivo cell therapy, drive AI-enhanced quality control and supply chain flexibility in global biopharma innovation.

A new Cue Biopharma–ImmunoScape partnership seeks to advance targeted TCR-T expansion for solid tumors, supporting broader access and improved clinical durability.

AI, gene therapy, top research breakthroughs, and more will be highlighted at this year’s AAPS PharmSci 360, according to programming chair, Mei He.

Shilpa Biologicals CEO Sridevi Khambhampaty addresses funding pressures, regional supply strategies, and expanding ADC development.

Biologics output improves via planning and automation as digitalization predicts batch outcomes, requiring strong data and worker expertise, KBI Biopharma’s Sigma Mostafa explains.

AI and innovative technology platforms are revolutionizing biopharma R&D and manufacturing, but success requires high data quality and next-gen solutions.

Codexis and Nitto Denko Avecia aim to advance next-gen siRNA production methods for improving scalability of RNA therapeutics.

Digital platforms, automation, and new tech are driving efficiency, innovation, and advanced skill building in biomanufacturing, according to Sigma Mostafa of KBI Biopharma.

Biopharma innovators were recognized at CPHI 2025 for advances in drug delivery, continuous bioprocessing, and supply chain capabilities shaping global therapies.

Silvia Scaglione of React4Life explores how organ-on-chip systems, AI, and multi-organ models are revolutionizing preclinical testing and advancing personalized therapeutics.