Author Archives: Millie Nelson

eBook: mRNA — Negotiating New Manufacturing Hurdles

The emergency authorization, regulatory approval, and successful commercialization of Pfizer–BioNTech’s and Moderna’s respective mRNA vaccines for SARS-CoV-2 have ignited considerable interest in the modality across the biopharmaceutical industry — and for good reasons. Establishing a platform process for mRNA production could facilitate and accelerate several aspects of vaccine development and manufacturing. Drug makers also intend to leverage benefits associated with cell-free bioprocessing. But as the contributors to this eBook show, mRNA remains a nascent modality, and companies must surmount new…

Innovative payment models needed for CGT market access, says experts

Current payment models must change to make gene therapies more accessible, say experts. The cost of gene therapies continues to be a hot topic in the industry. Last month, CSL Behring’s one-time gene therapy Hemgenix (etranacogene dezaparvovec) for hemophilia B received approval from the US Food and Drug Administration (FDA) with a list price of $3.5 million, making it the most expensive single-dose drug on the market. With such hefty costs, various firms are looking at solutions that could potentially drive…

AGC and Gore enter Protein A-based partnership

AGC Biologics and Gore have teamed up to improve downstream purification processes by using increased productivity of the Protein A step. The collaboration between contract development manufacturing organization (CDMO) AGC and W.L Gore & Associates (Gore) includes the entirety of GORE Protein Capture Devices with protein A, which the firm says advances productivity in Protein A purification. “The goal of this collaboration is to combine the expertise of two industry leaders, enabling them to work together to optimize a long-standing…

Digitization: Biopharma must keep up with rest of the world, says Cytiva

“You can watch your pizza’s progress on an app, but our customers cannot watch their batches of cells being cultured or have simple access batch data,” says Cytiva CEO Emmanuel Ligner. Welcome to the second section of BioProcess Insider’s two-part interview with Emmanuel Ligner, who has served as CEO of Cytiva since 2017. If you have not yet read the first part where Ligner discusses how messenger RNA (mRNA) will play a major role in healthcare in 2023 and beyond,…

Andelyn to make first infantile neuroaxonal dystrophy gene therapy

Andelyn Biosciences has partnered with the INADcure Foundation to bring the first-ever gene therapy for Infantile Neuroaxonal Dystrophy (INAD) to clinical trials. Contract development manufacturing organization (CDMO) Andelyn will deliver adeno associated-associated virus vectors (AAV) in a ready-to-use format to the INADcure Foundation. The foundation was formed in 2017 to accelerate development for the treatment of INAD and other types of PLA2G6-related neurodegeneration (PLAN). “Andelyn will manufacture the gene therapy under GMP and sterile conditions in specially qualified cleanrooms,” a…

Catalent to inject $40m to expand biologics services in NC

Catalent says it will invest up to $40 million to fit its 80,000 square-foot Durham, North Caroline facility with automation and digitization capabilities. Contract development manufacturing organization (CDMO) Catalent will establish a biologics analytical center in North Carolina’s Research Triangle (RTP) to provide its clients with standalone testing for biologic drug modalities, cell and gene therapies, and analytical development. “The new Durham facility, which was already purpose-built as laboratory space, will first need to be fitted out to meet the…

Inceptor Bio becomes third company to join Ori’s LEAP program

Inceptor has joined Ori Biotech’s LEAP program to advance solid tumor cell therapy access and bolster its manufacturing capabilities ahead of clinical trials. Inceptor has been granted pre-commercial access to Ori’s automated cell and gene therapy manufacturing platform and digital capabilities through joining the company’s LightSpeed Early Access Program (LEAP). Financial details of the deal have not been disclosed but it is confirmed that Inceptor will use Ori’s manufacturing platform technology to produce its chimeric antigen receptor (CAR) M, T,…

Seed financing round to develop Green Bioactives plant platform

Green Bioactives (GBL) has completed a £2.6 million ($3.1 million) seed financing round, which it says will accelerate its production, management, capabilities, and research team. According to GBL – a firm that focuses on the sustainable manufacture of natural products from plant cell cultures – it will use the funding round led by Eos Advisory LLP and others to follow sector-specific partnerships, increase product sales, up its marketing activity, and establish intellectual property (IP) across the company’s core biomanufacturing process…

Odimma to develop cancer therapy using Touchlight doggybone DNA tech

Odimma Therapeutics has entered into a clinical material supply agreement to develop personalized cancer therapies using Touchlight’s doggybone DNA platform. Under the terms of the deal, French biotech firm Odimma, will have access to Touchlight’s doggybone DNA (dbDNA) vector technology, which will provide the company with a clinical supply of material to be used in its oncological neoantigen program. “With a rapid timeline to GMP and high-fidelity process, dbDNA is helping to overcome existing industry bottlenecks and the challenges associated…

mRNA will be part of a solid landscape in 2023, says Cytiva

Emmanuel Ligner, CEO of Cytiva, predicts mRNA will become a well-proven modality with continued investment in clinical pipelines going beyond COVID. Messenger RNA (mRNA) made its mark on the biopharma landscape through the success of the COVID-19 vaccines, specifically the approval and rapid commercialization of products from companies including BioNTech and Moderna. While demand for these vaccines dwindle, the future of mRNA remains is bright, according to Emmanuel Ligner. Ligner, who has served as CEO of Cytiva since 2017, speaks…