Manufacturing

FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.

The Module Type Package standard is now supported in Emerson’s DCS and PLCs.

Currently, PNI offers a Genetic Medicine Toolkit, including its GenVoy LNP delivery platform and NanoAssemblr microfluidic-based nanoparticle manufacturing platform, for the development of genetic medicines.

The emergence of new biotherapeutics is both the driver and result of innovative drug development technologies.

Controlling certain atmospheric conditions in a closed NGI processing chamber can reduce bioburden without disinfectants.

Cell-free expression is promising in preclinical applications, but still presents challenges to scale up for commercial production.

Recent innovations in chromatography resins offer promising advantage in downstream bioprocessing.

Digitalization of bioprocessing operations, equipment, and facilities can improve workflow and output, but maintaining data integrity is a concern.

Container and equipment innovations expand applications.

The increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.

Expanded interest in advanced drug manufacturing and continuous production methods calls for more flexible production systems and regulatory policies.

The Discovery Labs has signed a foundational lease with the University of Pennsylvania Gene Therapy Program to build a new life sciences cluster in King of Prussia, Pa.

Moderna and Aldevron have expanded their existing collaboration to support Moderna’s COVID-19 vaccine program as well as additional clinical programs in Moderna’s pipeline.

Biogen and Ginkgo Bioworks have partnered to develop a next-generation AAV production platform to accelerate Biogen’s gene therapy drug development efforts.

Codagenix and Univercells have partnered on a research collaboration to pursue an undisclosed, high-priority human vaccine target.

Samsung Biologics plans to support the production of hundreds of millions of doses of Moderna’s vaccine to supply to markets outside of the United States beginning in the third quarter of 2021.

Under the terms of the agreement, Thermo Fisher will construct and operate a 44,000-ft2 cell therapy development, manufacturing, and collaboration center on UCSF's Mission Bay campus.

BD’s new high-tech manufacturing facility in Zaragoza, Spain, will create up to 600 jobs by 2030.

Sanofi and GlaxoSmithKline reported that their adjuvanted recombinant COVID-19 vaccine candidate demonstrated strong immune responses across all adult age groups in a Phase II trial.

Charles River plans to enhance its gene therapy capabilities through the acquisition of Vigene Biosciences.

WuXi Biologics and WuXi STA have established a joint venture company named WuXi XDC to provide contract development and manufacturing of bioconjugates, including antibody-drug conjugates.

The expected growth of the global bio/pharmaceutical market is pushing for the continued evolution of the CDMO arena.

As the RNA therapeutic market grows, contract manufacturing services for GMP-grade RNA are in demand and expected to continue on an upward trajectory.

Best practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.

Recent CDMO partnerships include COVID-19 collaborations, manufacturing partnerships, service agreements, and a strategic alliance expansion.