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Exothera, LogicBioTherapeutics, and Polyplus-transfection, are collaborating on the development of a scalable AAV manufacturing platform.

Exothera, LogicBioTherapeutics, and Polyplus Collaborate on Industrial-Scale AAV Manufacturing 

The new draft guidance describes a standards recognition program for regenerative medicine therapies.

FDA Publishes Guidance on Regenerative Medicine Therapies

The draft ICH Q9(R1) document details the importance of quality risk management principles.

FDA Publishes Draft Quality Risk Management Guidance

Yourway intends to construct a new manufacturing facility in the Dublin Airport Logistics Park.

Yourway Announces New European Depot in Dublin

The deal will see Spectrum market and distribute ANGUS’ biologics grade buffers in the United States and Canada.

Spectrum Chemical Strikes Buffers Distribution Deal with ANGUS Chemical Company

Precision BioSciences has released clinical trial data on CAR T therapy candidates PBCAR0191, PBCAR19B, and PBCAR269A.

Precision BioSciences Releases Data on CAR T Therapy Candidates

Moderna’s mRNA-1273.214 booster candidate exhibited an eight-fold boost in neutralizing geometric mean titers against Omicron.

Moderna Bivalent Booster Candidate Demonstrates Superior Antibody Response Against Omicron

REGENXBIO has opened a new in-house facility at its headquarters in Rockville, Md., that will be used to manufacture AAV gene therapies at commercial scale.

REGENXBIO Launches New Gene Therapy Manufacturing Facility in US

In the report, the agency presents the activities it accomplished in 2021 to protect and promote public health.

EMA Publishes 2021 Annual Report

Astellas Pharma has opened its new gene therapy manufacturing facility in Sanford, NC, which will support clinical- and commercial-scale manufacturing of AAV vectors for gene therapies.

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