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Product Quality in Focus

This webcast features: Tim Kelly, CEO, Oxford Biomedica Solutions. It is now fully apparent that product quality is critical to the performance of gene therapy products. In turn, regulatory expectations have risen dramatically for the quality of the viral vectors that are used to deliver such therapies. That said, yields from viral-vector production processes tend to be much lower than those for conventional protein products. The ability to address all aspects of product quality while still achieving high vector output…

The Critical Role of Predictive Bioreactor Characterization in Pharmaceutical Process-based Upscaling

In bioreactors, microorganisms or cell cultures produce complex therapeutic proteins and other biopharmaceuticals. The industrial production of those active pharmaceutical ingredients usually involves a seed train: the cells are run through many cultivation systems, which become larger with each passage (Upstream Process). An adequate number of cells for the inoculation of large-scale production bioreactors of 10,000 liters or more is generated. A prominent example from the growing mammalian cell culture processing sector is the upstream production process of monoclonal antibodies.…

Repligen: Robust bioprocess market will offset reduced COVID demand

Repligen has tweaked its guidance in the wake of diminishing COVID-related orders but remains positive going forward due to a “very strong order book” for its base business. For the first quarter 2022, Repligen Corporation reported record revenue of $206.4 million, 45% up on the same period last year. Despite this, the bioprocess vendor has reduced its full year guidance by 4% from $800-$830 million to $770-$800 million due to the fall in COVID-related demand, something expected to continue throughout…

Gamida’s off-the-shelf lymphoma cell therapy set for trials after hold lifted

The US FDA has released Gamida Cell from a clinical hold imposed last year, clearing the way for trials of GDA-201, a candidate off-the-shelf treatment for large B cell lymphomas. The Boston biotech firm announced the decision last week, also revealing that the US regulatory agency cleared its investigational new drug (IND) application for the product. CEO Julian Adams said, “FDA clearance of our IND for the cryopreserved formulation of GDA-201 represents a significant milestone for the company and reflects…

Quell and Cellistic partner to develop cell therapy platform

The aim of the collaboration is to support the expansion of Quell’s autologous T-regulatory (Treg) cell therapy pipeline using Cellistic’s knowledge of iPSC processes. Under the terms of the deal, Quell Therapeutics and human induced pluripotent stem cell (iPSC) technology development and manufacturing firm Cellistic will take part in joint research to form a process for differentiating iPSCs into functional Treg cell therapy products. According to Quell, it will contribute its Treg expertise and technologies, as well as characterizing Treg…

ATMPS gets US patent for blockchain for personalized meds

US authorities have granted ATMPS Ltd a patent for the use of blockchain technologies in the delivery of personalized medicines. ATMPS’ technology – known as Hataali – is designed to track personalized medicines from “vein to vein,” in other words from the initial harvesting of cells from a clinical trial participant to the production facility and back through a series of nodes. CEO Raja Sharif told us “Hataali is an incredibly flexible platform with a large array of potential uses…

US Gov awards $10.6m freeze-dried plasma contract to Terumo

Terumo Blood and Cell Technologies has won a $10.6 million contract from the US Government to continue freeze-dried plasma (FDP) development. Apheresis services firm Terumo Blood and Cell Technologies has entered into a contract with the Medical Technology Enterprise Consortium (MTEC), which is an Other Transaction Agreement (OTA) with the US Army Medical Research and Development Command. In 2016, Terumo was awarded initial funding of $1.9 million (potential to be increased to $16 million) from the US Government to support…

The Critical Role of Cell Culture Media Analysis in Cell and Gene Therapies Development

This webcast features: Graziella Piras, PhD, Bioprocessing Segment Director, 908 Devices. Unlike biotherapeutic proteins that benefit from decades of development and manufacturing experience, cell and gene therapies are still young. Producing these diverse therapeutics requires that various cells be used based on the specific application. Since various cells have different requirements, the medium used to culture them must be designed for optimal growth and/or productivity of each cell type. When the composition of the cell culture medium does not match…

Despite pandemic, Samsung Bio set to open ‘super plant’ early

Samsung Biologics says its fourth plant will begin operations by October — six months ahead of schedule.  Samsung Biologics announced plans for its so called ‘P4 Super Plant’ in August 2020. This week, the Korean contract development and manufacturing organization (CDMO) told stakeholders the first phase of biomanufacturing operations will begin in the coming months. “Samsung Biologics’ Plant 4 construction is expected to be partially operational by October 2022 to support 6 X 10 kL production capacity,” the firm said in…

Scorpion to build $650m biodefense-focused plant in Kansas

CDMO Scorpion Biological Services has entered a planned development partnership to construct a biodefense and biomanufacturing facility in Manhattan, Kansas. Contract development manufacturing organization (CDMO) Scorpion has announced a development collaboration with a private developer, the state of Kansas, and university affiliates to build a biodefense-focused large molecule and biologics biomanufacturing plant. According to the CDMO, the 500,000 square-foot plant will service around 144,000 L of biomanufacturing capacity across 48 bioreactors, which is being designed for large molecule biologics production.…