Manufacturing

The collaboration will combine Cytiva’s CGT manufacturing technologies with Cellular Origins' robotic manufacturing platform.

Webinar Date/Time: Wednesday, February 12th at 11:00 AM EST

Jane True, Dr Andreas Kuhn, and Dr Andy Geall discuss mRNA risks, costs, effectiveness, manufacturing logistics, public messaging, and regulatory challenges.

Jane True, Dr Andreas Kuhn, and Dr Andy Geall discuss mRNA risks, costs, effectiveness, manufacturing logistics, public messaging, and regulatory challenges.

Jane True, Dr Andreas Kuhn, and Dr Andy Geall discuss mRNA risks, costs, effectiveness, manufacturing logistics, public messaging, and regulatory challenges.

The manufacturing agreement is expected to run through December 2030, subject to change, with production to take place at Samsung Biologics’ Songdo, South Korea, site.

Under a global alliance with the Australian non-profit GC4K and Weill Cornell Medicine, PackGene aims to deliver a custom-tailored gene therapy solution for hereditary spastic paraplegia type 56, an exceptionally rare neurological disease.

Atul Mohindra, head of Biologics R&D at Lonza, discusses the challenges and successes of bispecific antibodies as well as the field’s future direction from a CDMO perspective.

Advancements in bioprocessing and analytics are crucial to the future development of bispecific antibodies and beyond.

Emerging therapies, patient-centric medicines, and the ever-changing world of bio/pharmaceuticals complicate technology transfer.

Optimizing the harvest of viral particles is important for the yield and purity of the final product.

Nicolas Pivet, vice-president and general manager, Technology Solutions at Cytiva, discusses how automation benefits process development, particularly in the analytical space.

Contract development and manufacturing organizations (CDMOs) are more critical than ever as the demand for advanced therapies continues to grow.

Bob Schrock, PhD, senior director, global head of Process Development, at Lonza provides insight on how cell culture processes may be optimized and what kind of process studies are performed for cell culture.

Using Orexo’s powder-based drug delivery technology, the companies will develop mucosal vaccines in an inhaled formulation.

The company has formed Scinai Bioservices Inc., new US-based subsidiary operating out of Delaware that will serve biotech companies in early stage drug development.

This article looks at how the MAPPs assay works, how it integrates with other immunogenicity assays, and just how it can be flipped to help in vaccine design.

In part two of a video interview, Colin McKinlay, PhD, senior director, Chemistry and Delivery Technologies, at Nutcracker Therapeutics, talks on current trends and the direction that mRNA–LNP development may take going forward.

With the DKK 8.5 billion (US$1.2 billion) investment, Novo Nordisk will build a new modular and flexible production facility in Odense, Denmark, to produce multiple products for rare diseases.

In a discussion on mRNA and LNP development, Colin McKinlay, the senior director of Chemistry and Delivery Technologies at Nutcracker Therapeutics, points out current challenges and innovations that meet these challenges.

The company will add a new laboratory facility at its Shanbally, Co. Cork, Ireland, manufacturing site.

The European Commission’s approval of the Catalent acquisition by Novo Holdings includes the related acquisition of three manufacturing sites by Novo Nordisk, which is also acquiring the Czech Republic manufacturing site of Novavax for $200 million.

Cambrex will provide Lilly’s biotech collaborators with accelerated access to clinical development capabilities.

A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study.

EXO Biologics and its subsidiary, ExoXpert, have received GMP certification of a European exosomes manufacturing facility and have successfully loaded mRNA and DNA payloads into GMP-grade exosomes for drug delivery.

All CGMP requirements, including supporting activities, are critical in aseptic sterile manufacturing to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

As biopharma anticipates the “Facility of the Future,” a definition of what closed processing is, and quantification of its value, can be helpful information.

Jason Bock, co-founder and CEO of CTMC, discusses the industry impact and manufacture of patient-centered medicines.

Operating in an aging facility and/or utilizing outdated equipment may lead to drug shortages and high operating costs.

Modular and replication strategies are being utilized to meet growing demand for CDMO facilities.