An ambitious ten‐year collaborative program is described to invent, design, demonstrate and support commercialization of integrated biopharmaceutical manufacturing technology intended to transform the industry. Our goal is to enable improved control, robustness and security of supply, and dramatically reduced capital and operating cost, flexibility to supply an extremely diverse and changing portfolio

Retroviral gene delivery is widely used in T cell therapies for hematological cancers. However, viral vectors are expensive to manufacture, integrate genes in semi‐random patterns, and their transduction efficiency varies between patients. In this study, several non‐viral gene delivery vehicles, promoters, and additional variables were compared to optimize non‐viral transgene delivery and expression

Continuous capture with affinity chromatography is one of the most important units for continuous manufacturing of monoclonal antibody (mAb). Due to the complexity of three‐column periodic counter‐current chromatography (3C‐PCC), three approaches (experimental, model‐based and simplified approaches) were studied for process development and optimization. The effects of residence time for interconnected

UV‐visible spectroscopy (UV‐Vis) is routinely used in microbiology as a tool to check the optical density (OD) pertaining to the growth stages of microbial cultures at the single wavelength of 600 nm, better known as the OD600. Typically, modern UV‐Vis spectrophotometers can scan in the region of approximately 200–1000 nm in the electromagnetic spectrum, where users do not extend the use of the instrument's

The United States produces more than 10 million tons of waste oils and fats each year. This paper aims to establish a new biomanufacturing platform that convert waste oils or fats into a series of value‐added products. Our research employs the oleaginous yeast Yarrowia lipolytica as a case study for citric acid (CA) production from waste oils. First, we conducted the CFD simulation of the bioreactor

HIV‐1 Gag virus‐like particles (VLPs) are promising candidates for the development of future vaccines. Recent viral outbreaks have manifested the need of robust vaccine production platforms able to adapt to new challenges while achieving mass production capacity. For the rapid production of VLPs, the method of transient gene expression (TGE) have proved highly efficient. Based on a previous characterization

Magnetoelastic (ME) sensors, which can be remotely activated via magnetic fields, are an excellent choice for wireless monitoring of biological parameters due to their ability to be scaled into different sizes and have their surface functionalized for chemical or biological sensing. In this study, we present the application of a commercially available ME material (Metglas 2826 MB) to develop a sensor

Integrated continuous downstream processes with process analytical technology offer a promising opportunity to reduce production costs and increase process flexibility and adaptability. In this case study, an integrated continuous process was used to purify a recombinant protein on laboratory scale in a two‐system setup that can be used as a general downstream setup offering multi‐product and multi‐purpose

The commensal gut bacterium Akkermansia muciniphila is well known as a promising probiotic candidate that improves host health and prevents diseases. However, the biological interaction of A. muciniphila with human gut epithelial cells has rarely been explored for use in biotherapeutics. Here, we developed an in vitro device that simulates the gut epithelium to elucidate the biological effects of living

Bionanotechnology has increasingly gained attention in biomedical fields as antifungal and antibiofilm agents. This study biosynthesized silver nanoparticles (bio‐AgNPs) using aqueous Eucalyptus camaldulensis leaf extract were successfully performed by a one‐step green approach. Spherical‐shaped nanoparticles, approximate size of 8.65 nm exhibited non‐cytotoxicity to erythrocytes, HeLa, and HaCaT cells

There has been increasing momentum recently in the biopharmaceutical industry to transition from traditional batch processes to next‐generation integrated and continuous biomanufacturing. This transition from batch to continuous is expected to offer several advantages which, taken together, could significantly improve access to biologics drugs for patients. Despite this recent momentum, there has not

SARS‐CoV‐2 has spread rapidly throughout the whole world and caused significant difficulties in the prevention and control of the epidemic. In this case, several detection methods have been established based on nucleic acid diagnostic techniques and immunoassays to achieve sensitive and specific detection of SARS‐CoV‐2. However, most methods are still largely dependent on professional instruments,

Microalgae have expanded their roles as renewable and sustainable feedstocks for biofuel, smart nutrition, biopharmaceutical, cosmeceutical, biosensing, and space technologies. They accumulate valuable biochemical compounds from protein, carbohydrate, and lipid groups, including pigments and carotenoids. Microalgal biomass, which can be adopted for multivalorization under biorefinery settings, allows

Maturation of human‐induced pluripotent stem cells (hiPSCs)‐derived hepatocytes‐like cells (HLCs) toward a complete hepatocyte phenotype remains a challenge as primitiveness patterns are still commonly observed. In this work, we propose a modified differentiation protocol for those cells which includes a pre‐maturation in Petri dishes and a maturation in microfluidic biochip. For the first time, a

This paper reports the first implementation of a new type of mass spectral library for the analysis of Chinese hamster ovary (CHO) cell metabolites that allows users to quickly identify most compounds in any complex metabolite sample. We also describe an annotation methodology developed to filter out artifacts and low‐quality spectra from recurrent unidentified spectra of metabolites. CHO cells are

A versatile peptide‐toolbox for surface functionalization was established by a combination of a universal material binding peptide (LCI‐anchor peptide) and sortase‐mediated bioconjugation (sortagging). This toolbox facilitates surface functionalization either as a one‐ or a two‐step strategy. In case of the one‐step strategy, the desired functionality was directly introduced to LCI. For the two‐step

Epidermal Growth Factor Receptor (EGFR) is a clinically validated target for a multitude of human cancers. The receptor is activated upon ligand binding through a critical dimerization step. Dimerization can be replicated in vitro by locally concentrating the receptor kinase domains on the surface of lipid‐based vesicles. In this work we investigated the use of coiled coils to induce spontaneous receptor

A high degree of charge heterogeneity is an unfavorable phenomenon commonly observed for therapeutic monoclonal antibodies (mAbs). Removal of these impurities during manufacturing often comes at the cost of impaired step yields. A wide spectrum of posttranslational and chemical modifications is known to modify mAb charge. However, a deeper understanding of underlying mechanisms triggering charged species

Biochemical engineering at MIT emerged in the 1950's with a focus on the use of fermentation technology for traditional food and beverage processing and the increasing demands of antibiotics production.