Manufacturing

Agnes Shanley is senior editor of Pharmaceutical Technology.

Articles

In January 2020, the agency finalized six clinical development and manufacturing guidance documents and drafted new guidance on what would qualify new gene therapies as orphan drugs.

Inside FDA’s New Gene and Cell Therapy Guidances

Tackling process development early on can better optimize manufacturing processes for emerging therapies.

Optimizing Process Development for Emerging Therapies

The growing interest in developing cell and gene therapies has prompted industry investment to grow manufacturing capacity.

Investments Inject Growth in Cell and Gene Therapies

The last year has seen intense investment activity into raising cell and gene therapy manufacturing capacity.

Industry pushes forward with cell and gene therapies

The 135,000 square foot facility will be constructed over 18 months and is expected to be operational in 2021.

Audentes to Invest $109 Million into Gene Therapy Manufacturing Facility

New funding brings competitors, and a leading healthcare products distributor, into the standardization effort.


Novartis, Kite, and Cardinal Health Invest in Cell and Gene Therapy Infrastructure

The new facility includes six classified environment rooms with space to expand.

Hitachi Chemical Opens New Cell and Gene Therapy Manufacturing Facility

Alberto Santagostino is senior vice-president and head of cell and gene technologies at Lonza Pharma and Biotech. 

Contract partners must help innovators, especially smaller and virtual companies, consider manufacturability as early as possible in development. This requires focusing on technical and operational performance, as well as cost. 

Using the ‘Cubic Effect’ to Drive Cell and Gene Therapy Commercialization

Vein-to-vein programs are focusing on data access and traceability. 

Managing Risk for Cell and Gene Therapy Logistics

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

As cell and gene therapies become more prominent, industry is seeking the expertise and capabilities of outsourcing partners to ensure success.

Manufacturing, Gene Therapies