Tag: <span>cell therapy</span>

Maximizing Performance of pH Measurements for Inline Conditioning Buffer Preparation for Chromatography

In biopharmaceutical manufacturing, buffer preparation is traditionally performed manually by dissolving solid salts in water for injection (WFI) followed by offline mixing and specification testing. This method requires large buffer volumes, extensive infrastructure, and significant labor, often creating bottlenecks in production. To address these limitations and support process intensification, inline buffer preparation technologies have emerged…

Read MoreMaximizing Performance of pH Measurements for Inline Conditioning Buffer Preparation for Chromatography

Biologics Production

biologics cell therapy cleaning-in-place continuous buffer release downstream purification dynamic flow in-line conditioning in-line dilution inline conditioning inline dilution inline ph monitoring ion traps on-demand buffer formulation ph probes ph sensor designs process analytical technology salt memory sensor drift sodium hydroxide cip wfi

Assessment of a New Automatic, Water-Free Thawing Device Specially Designed for the Context of the Cell Therapy Industry

The number of cellular therapies in clinical trials and on the market has continued to rise significantly in recent years—and so does the need to maintain strict control over all manufacturing steps in order to reduce batch-to-batch variability. One potential source of product variability is the manual thawing of cryopreserved cells in a water bath, which can differ between operators. Additionally, water baths pose a significant contamination risk, making them less suitable for GMP environments. To overcome these challenges, several companies have developed water-free thawing devices that offer better control of the thawing process. However, these devices either accommodate only one vial at a time or lack U.S.
FDA 21 CFR 11 compliance in producing a computer-generated audit trail. Hence, we have developed a novel, water-free and dry-heat-based, fully programmable thawing device that is capable of thawing up to ten vials simultaneously and complies with 21 CFR11 requirements…

Read MoreAssessment of a New Automatic, Water-Free Thawing Device Specially Designed for the Context of the Cell Therapy Industry

Biologics Production

adipose-derived MSC adipose-derived stem ASC biologics cell thawing cell therapy cellular therapies novel thawing device water-free thawing

Development and Assessment of a Novel Device for the Controlled, Dry Thawing of Cryopreserved Cell Products

While playing an integral role in biotechnology and medicine, cryopreservation (CP) is often viewed as a “simple tool” and is overlooked as a critical and evolving component of cell and tissue bioprocessing. Despite this, cryopreservation serves as an enabling technology in numerous areas including the latest cell therapies. For example, over one third of the cells used in clinical trials are cryopreserved using the traditional methods, which in many cases yield suboptimal outcomes. Further, researchers still rely on the assessment of cell survival immediately post-thaw (within a few hours), and fail to account for the impact of cryopreservation-induced delayed-onset cell death (CIDOCD) which continues to impact survival from hours to days post-thaw.

Read MoreDevelopment and Assessment of a Novel Device for the Controlled, Dry Thawing of Cryopreserved Cell Products

Biologics Biologics Production Bioreactor Scale-Up Cell & Gene Therapy Cell Lines Fed-Batch Bioreactor Process HEK293 Mammalian Cell Culture Manufacturing Regulatory Viral Reference Materials Viral Vectors

biodefense cell recovery cell repopulation cell research cell therapy cell viability cellular preservation cellular products cp cryopreservation cryothawing dmso dry thawing gene therapy high-throughput screening research science smartthaw stem cells water bath thawing

Using a Patient-Centered Risk-Benefit Structure and Appropriate Manufacturing Practices (AMPs) for Successfully Developing and Manufacturing Effective Cell Therapy Products

The development and manufacturing of advanced breakthrough cell therapies presents a wide variety of complex challenges that include:
• delivering the medical science, from research all the way through product development and clinical testing, to the patient population;
• understanding and defining the product’s modes of activity and the cell’s attributes necessary to attain therapeutic benefit and safety;
• overcoming significant manufacturing, logistical, and cost of goods issues associated with using attachment-dependent bioreactor systems; and
• defining product release challenges associated with rapidly delivering an effective product to the patients.

Read MoreUsing a Patient-Centered Risk-Benefit Structure and Appropriate Manufacturing Practices (AMPs) for Successfully Developing and Manufacturing Effective Cell Therapy Products

Biologics Biologics Production Bioreactor Scale-Up Cell & Gene Therapy Cell Lines Fed-Batch Bioreactor Process HEK293 Mammalian Cell Culture Manufacturing Regulatory Viral Reference Materials Viral Vectors

amps appropriate manufacturing practices cell therapy cellular therapy cost of goods cqas critical quality attributes preclinical manufacturing process lifecycle paradigms risk-benefit structure