A5084692846- SARS-CoV-2 and COVID-19 Research
- Viral Infectious Diseases and Gene Expression in Insects
- Protein purification and stability
- Monoclonal and Polyclonal Antibodies Research
- Microbial Metabolic Engineering and Bioproduction
- Animal Virus Infections Studies
- SARS-CoV-2 detection and testing
- Glycosylation and Glycoproteins Research
- vaccines and immunoinformatics approaches
- COVID-19 Clinical Research Studies
- Metabolomics and Mass Spectrometry Studies
- Biofuel production and bioconversion
- Immunotherapy and Immune Responses
- Innovative Microfluidic and Catalytic Techniques Innovation
- Biosimilars and Bioanalytical Methods
- Long-Term Effects of COVID-19
- Influenza Virus Research Studies
- Medical Research and Treatments
- 3D Printing in Biomedical Research
- Nanoplatforms for cancer theranostics
- Computational Drug Discovery Methods
- Bacterial Infections and Vaccines
- Biotechnology and Related Fields
- Viral Infections and Immunology Research
- Heparin-Induced Thrombocytopenia and Thrombosis
Center of Molecular Immunology (Cuba)
1997-2025
Controlling the global COVID-19 pandemic depends, among other measures, on developing preventive vaccines at an unprecedented pace. Vaccines approved for use and those in development intend to elicit neutralizing antibodies block viral sites binding host's cellular receptors. Virus infection is mediated by spike glycoprotein trimer virion surface via its receptor domain (RBD). Antibody response this important outcome of immunization correlates well with neutralization. Here, we show that...
Abstract The high prices of biopharmaceuticals or biologics used in the treatment many diseases limit access patients to these novel therapies. One example is monoclonal antibody trastuzumab, successfully for breast cancer treatment. An economic alternative generation biosimilars expensive biopharmaceuticals. Since therapies may require large doses over a long period time, robust platforms and strategies cell line development are essential recombinant lines with higher levels expression....
Soberana01 is composed of the SARS-CoV-2 dimeric RBD and Neisseria meningitidis outer membrane vesicles (OMVs) adsorbed on alum. This vaccine induces a potent neutralizing immune response shows potential against variants concern.
The cell culture is the central piece of a biotechnological industrial process. It includes upstream (e.g. media preparation, fixed costs, etc.) and downstream steps product purification, waste disposal, etc.). In continuous mode culture, constant flow fresh replaces fluid until system reaches steady state. This state standard operation which, under very general conditions, function ratio between density dilution rate depends on supplied to culture. To optimize production process it widely...
Subunit vaccines based on the receptor-binding domain (RBD) of spike protein SARS-CoV-2 provide one most promising strategies to fight COVID-19 pandemic. The detailed characterization primary structure by mass spectrometry (MS) is mandatory, as described in ICHQ6B guidelines. In this work, several recombinant RBD proteins produced five expression systems were characterized using a non-conventional protocol known in-solution buffer-free digestion (BFD). single ESI-MS spectrum, BFD allowed...
Abstract The COVID-19 pandemic has caused a large number of diseases worldwide. There are few vaccines to constrain this disease and the value them is high. In sense, antigens vaccine platform Soberana, receptor binding domain from SARS-CoV-2 Spike protein, both monomeric (mRBD) dimeric (dRBD) forms, have been developed. This study encompassed several analyses by different techniques like circular dichroism (CD), fluorescence spectroscopy (FS) Gel Filtration- High Performance Liquid ChLC...
Abstract Background SOBERANA 02 is a COVID-19 conjugate vaccine candidate based on SARS-CoV-2 recombinant RBD conjugated to tetanus toxoid. Plus antigen dimeric-RBD. Here we report safety, reactogenicity and immunogenicity from phase I IIa clinical trials using two-doses (homologous protocol) three-doses (homologous) or heterologous (with Plus) protocols. Method We performed an open-label, monocentric, sequential adaptive for evaluating exploring of in two formulations (15 25 μg) 40...
Abstract Background We report results of immunogenicity, safety and reactogenicity SOBERANA 02 in a two-dose or three-dose heterologous scheme adults phase IIb clinical trial. Method This trial was designed as parallel, multicentre, adaptive, double blind, randomized placebo-controlled. Subjects (N=810) aged 19-80 years were to receive two doses the recombinant SARS CoV-2 receptor binding domain (RBD) conjugated tetanus toxoid (SOBERANA 02) third dose dimeric RBD Plus) 28 days apart;...
Abstract Controlling the global COVID-19 pandemic depends, among other measures, on developing preventive vaccines at an unprecedented pace. Vaccines approved for use and those in development intend to neutralizing antibodies block viral sites binding host’s cellular receptors. Virus infection is mediated by spike glycoprotein trimer virion surface via its receptor domain (RBD). Antibody response this important outcome of immunization correlates well with neutralization. Here we show that...
Abstract Subunit vaccines based on the receptor-binding domain (RBD) of spike protein SARS-CoV-2, are among most promising strategies to fight COVID-19 pandemic. The detailed characterization primary structure by mass spectrometry (MS) is mandatory, as described in ICHQ6B guidelines. In this work, several recombinant RBD proteins produced five expression systems were characterized using a non-conventional protocol known in-solution buffer-free digestion (BFD). single ESI-MS spectrum, BFD...
We have developed a single process for producing two key COVID-19 vaccine antigens: SARS-CoV-2 receptor binding domain (RBD) monomer and dimer. These antigens are featured in various formats, including SOBERANA 01 the licensed 02, Plus. Our approach involves expressing RBD (319-541)-His6 Chinese hamster ovary (CHO)-K1 cells, generating characterizing oligoclones, selecting best RBD-producing clones. Critical parameters such as copper supplementation culture medium cell viability influenced...
Human Embryonic Kidney cells (HEK293) are a popular host for recombinant protein expression and production in the biotechnological industry. This has driven within both, scientific engineering communities, search strategies to increase their productivity. The present work is inserted into this exploring impact of adding sodium acetate (NaAc) batch culture HEK293 cells. We monitored, as function time, cell density, many external metabolites, supernatant concentration heterologous...
Abstract SOBERANA ® 02 is a safe and effective conjugate vaccine against SARS-CoV-2, produced using the maleimide-thiol chemistry. In this vaccine, Cys 538 in recombinant receptor binding domain (RBD) of SARS-CoV-2 linked, through thiosuccinimide linker, to lysine residues tetanus toxoid (TT) preparation. LC-MS/MS analysis revealed that TT complex mixture proteins, similar other TTs where detoxified neurotoxin (d-TeNT) has been shown be most abundant protein (30-56%), regardless...
The data for provide evidences of the multi steady state human cell line HEK 293 was obtained from 2L bioreactor continuous culture. A transfected to produce soluble HER1 receptor used. operated at three different dilution rates in sequential manner. Daily samples culture broth were collected, a total 85 processed. Viable concentration and viability addressing by trypan blue exclusion method using hemocytometer. Heterologous Her1 supernatant quantified specific ELISA metabolites mass...
The data for provide evidences of the multi steady state human cell line HEK 293 was obtained from 2L bioreactor continuous culture. A transfected to produce soluble HER1 receptor used. operated at three different dilution rates in sequential manner. Daily samples culture broth were collected, a total 85 processed. Viable concentration and viability addressing by trypan blue exclusion method using hemocytometer. Heterologous supernatant quantified specific ELISA metabolites mass spectrometry...