Manufacturing

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 growing demand for liquid medicines is driven by patient groups' unique needs, improving compliance through flexible and palatable dosing options.

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.

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

On July 31, President Donald Trump said the federal government would “deploy every tool in our arsenal to protect American families from continued abusive drug pricing practices” should companies fail to comply.

Webinar Date/Time: Wed, Oct 22, 2025 11:00 AM EDT

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

The 100% tariff on imported drugs will pressure biopharma companies to build manufacturing sites in the US or face significant costs.

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

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

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

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

Engineered biosynthetic pathways provide new avenues for accessing complex molecules.

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.

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.

Allogeneic CAR-T therapies deliver scalable, off-the-shelf cancer therapy, while autologous CAR-T therapies provide patient-specific but time-intensive treatment.

This collaboration between Andelyn Biosciences and Tern Therapeutics moves the gene therapy TTX-381 closer to approval for treating vision loss linked to CLN2 Batten disease.

The partnership expands patient access in MENA by localizing biosimilar manufacturing and distribution for gastro, neuro, and dermatology treatments.

Webinar Date/Time: Wed, Sep 24, 2025 11:00 AM EDT

The authors examine common FDA 483 findings and outline strategies to address and prevent regulatory non-compliance.

The acquisition expands tubular glass vial and ampoule capacity, expanding ready-to-use glass packaging capabilities in Europe.

Moderna’s updated Spikevax and mNEXSPIKE COVID-19 vaccines target the LP.8.1 variant of SARS-CoV-2 for high-risk groups and older adults.