Feliza Mirasol

Industry leaders at Meeting on the Mesa discussed big biopharma’s role in next-step CGT scale, focusing on manufacturing quality and patient access.

To increase CAR-T patient access, healthcare professionals must standardize high-quality delivery, shift to outpatient settings, and overcome current logistical barriers, industry leaders said at a session during the Cell and Gene Meeting on the Mesa.

In a session at the Cell and Gene Meeting on the Mesa, Prime Medicine CEO Allan Reine discussed how prime editing offers versatile, safe gene correction, but that delivery to target cells remains a major hurdle.

A panel at the Cell and Gene Meeting on the Mesa discussed how advanced therapy production demands modular platforms, automation, and data governance to drastically improve patient access and affordability.

In this week’s news, industry shifts are marked by new FDA draft guidances, Pfizer’s agreement to MFN pricing, Novartis’ launch of DTP distribution, and AI-driven protein design.

Naobios and Olon France create custom HCP ELISA to advance vaccine trials and strengthen global biopharmaceutical manufacturing capacity.

The regulatory progress for AAVantgarde’s AAVB-039 underscores advances in dual-vector gene therapy, as well as scalable manufacturing and efficient rare-disease clinical development.

The study by Integra Therapeutics and partners reveals how AI-engineered proteins could expand gene-editing tools and streamline development of advanced therapies.

This new draft guidance mandates efficient, long-term CGT postapproval monitoring using real-world evidence, registries, and decentralized models, all critical for biopharma.

This innovative trial guidance accelerates cell and gene therapy development for rare diseases, boosting biopharma efficiency and data maximization.

Novartis expands its immunology pipeline with the Tourmaline acquisition and tests direct-to-patient model to reshape drug manufacturing strategies.

This week’s roundup highlights US manufacturing localization via tariffs, Pfizer’s $4.9 billion deal, and new tech in CRISPR, RNA, and continuous processing.

The new protein-based HDR enhancer aims to improve CRISPR precision for advancing cell and gene therapy development workflows.

BIO-Europe 2025 in Vienna will gather global biopharma leaders to explore investment, manufacturing, and rare disease innovation.

RION partners with Lonza for CGMP manufacturing of PEP, advancing exosome drug development and scalable biopharma production.

Pfizer will expand its obesity drug pipeline with Metsera’s clinical incretin and amylin programs, highlighting advances in biopharma development and manufacturing.

New GS knockout CHO-K1 systems accelerate biologics manufacturing by improving yields, scalability, and flexibility for biopharma development programs.

Regulatory crackdowns on risk disclosure rise, policy instability affects public health, and drug innovation focuses on advanced therapies and AI-driven discovery.

ACIP votes to separate MMR and varicella vaccines (MMRV) for children to cut febrile seizure rates.

CPHI Pharma Awards 2025 highlight breakthroughs in bio/pharma technology, sustainable manufacturing, and industry leadership.

The Phase IIa trial will further explore the EP4 antagonist HTL0039732 in combination with immunotherapy to improve outcomes in resistant solid tumors and expand treatment options.

SynaptixBio CEO Dan Williams discusses how small biotechs drive rare disease innovation with genetic research, partnerships, and patient advocacy in a third interview installment.

CSL will fund Phase III clinical development of VMX-C001 with an option to acquire VarmX.

A collaboration between Limula and Institut Paoli-Calmettes aims to advance automated stem cell transplant processing to improve cryoprotectant removal, enhance patient outcomes, and streamline manufacturing.

Novartis and Monte Rosa expand collaboration using AI-driven molecular glue degraders to advance drug development for immune-mediated diseases.

FDA transparency, AI in manufacturing, automation for quality, and cell/gene therapy advancements are driving the biopharma industry forward.

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

Automated facility upgrades for cell therapy enhance quality assurance, ensure regulatory compliance, and boost operational efficiency by minimizing manual risks.

Strategic AI integration in bio/pharma manufacturing enhances GxP compliance, quality, and operational efficiency through robust governance and risk management.

Data integrity and quality are paramount for drug discovery, manufacturing efficiency, regulatory compliance, and patient safety.