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AGC Biologics To Expand Their CDMO Facility. 

AGC Biologics announced that it is expanding the production capacity of its Copenhagen facility with the construction of a new building neighboring its current site with the addition of production floors containing bioreactors, labs, and office space. 

The company has invested $194 million for this new facility and expects to open it by 2023.

This expansion will more than double the company’s single-use bioreactor mammalian cell-culture capacity in Copenhagen, allowing them to meet the needs of the market.

(來源:美通社,2020)


Amicus Therapeutics Submits Biologics License Application to the US FDA for AT-GAA in Late onset Pompe disease

The rolling Biologics License Application (BLA) submission to the US Food and Drug Administration (FDA) allows Amicus Therapeutics to submit parts of the regulatory application rather than wait until every section of the BLA is complete to give the entire application for review.

AT-GAA is an investigational therapy that consists of cipaglucosidase alfa (ATB200) administered in conjunction with miglustat (AT2221), an orally administered stabilizer of cipaglucosidase alfa. 

Amicus has submitted the non-clinical component of the cipaglucosidase alfa BLA and is on-course for the submission of the chemistry, manufacturing, and controls (CMC) component, and the final clinical module in the first half of 2021. 

The cipaglucosidase alfa is to be used along miglustat, which will be a separate NDA submitted at the same time as the remainder of the cipaglucosidase alfa BLA.

(來源:《全球新聞通訊》,2020年)


Royal Biologics Launches Fibri-Cell, Live Cellular Cortical Fibers.

Royal Biologics recently announced the launch of FIBRI-CELL™ with Osteo-Spin™ technology which offers a fresh and innovative approach for the enhancement of traditional bone graft substitutes for orthopedic fusion procedures.

FIBRI-CELL™ uses Royal’s Osteo-Spin™ technology to deliver activated platelets, bone marrow aspirate, and cortical fibers in an “ultra-hydrated” blend, creating a point of care live cellular bone graft option.

The company states that this has allowed them to harness the power of each patient’s cells by combining activated autologous blood platelets and bone marrow aspirate growth factors in a next-generation scaffold. 

Osteo-Spin™ technology demonstrates the unique ability to capture a patient’s cells, optimizing all unique growth factors, for superior wicking and handling characteristics. 

Traditional hydration of allograft and autograft is now improved by accelerating the adherence of cells to each scaffold.

(Source: Ortho Spine News, 2020)