Abstract: Disclosed herein are methods of preparing a composition comprising crystalline biomolecules, for example, crystalline antibodies. In exemplary embodiments, the method comprises forming a fluidized bed of crystalline biomolecules using, for example, a counter-flow centrifuge to exchange buffer and/or to concentrate the crystalline biomolecules in a solution. Also provided are methods of detecting crystalline biomolecules and/or amorphous biomolecules in a sample.

Abstract: The invention relates to the identification of fusion proteins comprising polypeptide and protein variants of fibroblast growth factor 21 (FGF21) with improved pharmaceutical properties. Also disclosed are methods for treating FGF21-associated disorders, including metabolic conditions.

Abstract: The present disclosure relates to a polypeptide exhibiting granulocyte-colony stimulating factor activity. The polypeptide comprises at least one non-native cysteine residue at a site selected from the group consisting of T1CP2 (SEQ ID NO: 25), P2CL3 (SEQ ID NO: 26), L3CG4 (SEQ ID NO: 27), G4CP5 (SEQ ID NO: 28), P5CA6 (SEQ ID NO: 29), A6CS7 (SEQ ID NO: 30), S96CP97 (SEQ ID NO: 31), P97CE98 (SEQ ID NO: 32), L99CG100 (SEQ ID NO: 33), P101CT102 (SEQ ID NO: 34), E122CE123 (SEQ ID NO: 35), L124CG125 (SEQ ID NO: 36), M126CA127 (SEQ ID NO: 37), P138CA139 (SEQ ID NO: 39), A143CF144 (SEQ ID NO: 40), R146CR147 (SEQ ID NO: 41), R169CH170 (SEQ ID NO: 42), H170CL171 (SEQ ID NO: 43), L171CA172 (SEQ ID NO: 44), A172CQ173 (SEQ ID NO: 45), and Q173CP174 (SEQ ID NO: 46) in an amino acid sequence having at least 90% sequence identity to sequence set forth in SEQ ID NO: 2.

Abstract: A prefilled syringe and a method of filling a syringe with a pegfilgrastim solution to provide a target extracted volume of pegfilgrastim solution from the syringe are described. A method includes selecting the target extracted volume of pegfilgrastim solution, determining an estimated drug transfer loss, determining an estimated syringe dead volume, filling the syringe with a volume of pegfilgrastim solution comprising at least the target extracted volume plus the estimated drug transfer loss plus the estimated syringe dead volume.

Abstract: The present invention relates to a method for removing water from a compound solution and performing conjugate acid conversion. The method uses a nanometer film to perform reverse osmosis for the compound solution to remove water, and provides a conjugate acid to replace the acidic substances in the compound solution in order to obtain compound conjugate acid salts. The method of the present invention can effectively reduce the water content of the compound solution and replace the conjugate acid of the compound to form the desired compound conjugate acid salt.

Abstract: Analogs for CLR/RAMP receptor ligands are provided that have agonist, superagonist, antagonist, super-antagonist, or multiple receptor modulating activity. The analogs can be selective for one or more CLR/RAMP receptors, or can be pan-specific for multiple G protein-coupled receptors.

Abstract: Provided herein are methods for refolding denatured protein (e.g., from inclusion bodies) that do not require the use of a denaturing agent. Exemplary methods use a high pH for solubilizing denatured protein, followed by a decrease in pH for refolding the proteins.

Abstract: The present invention provides dominant negative mutants of FGF2 for suppressing FGF-mediated cellular signaling. Related compositions, methods, and kits are disclosed.

Abstract: The invention relates to nucleic acids encoding fusion proteins comprising polypeptide and protein variants of fibroblast growth factor 21 (FGF21) with improved pharmaceutical properties. Also disclosed are vectors and host cells comprising the same and methods of producing the fusion proteins.

Abstract: The present invention relates to mutants of Fibroblast Growth Factor (FGF), particularly FGF-20 and FGF-21, which contain newly introduced N-linked or O-linked glycosylation site(s). The polynucleotide coding sequences for the mutants, expression cassettes comprising the coding sequences, cells expressing the mutants, and methods for producing the mutants are also disclosed. Further disclosed are pharmaceutical compositions comprising the mutants and method for using the mutants.

Abstract: A process for solubilization and refolding of precursor insulin or insulin analogs from inclusion body isolates for use in the production of insulin or insulin analog is described.

Abstract: Disclosed is a chromatographic method for isolating and purifying high-purity recombined human serum albumin, comprising: conducting cation-exchange chromatography on recombined human serum albumin, and adding alcohol to a buffer solution to remove endotoxin, so as to obtain a primary product I; under binding conditions, conducting anion/hydrophobic composite resin exchange chromatography on the primary product I to obtain an intermediate product II; conducting hydrophobic chromatography on the intermediate product II to obtain the target product, the purified high-purity recombined human serum albumin. The purity of the recombined human serum albumin obtained by isolating and purifying with the chromatographic method of the present invention is greater than 99.9999%, and the content of the endotoxin meets the criteria stipulated by Chinese pharmacopoeia.

Abstract: Herein is reported a method for obtaining a polypeptide in monomeric form comprising the steps of a) providing a solution comprising the polypeptide in monomeric form and in aggregated form, wherein the ratio of monomeric to aggregated form is 4:1 or less as determined by size exclusion chromatography, b) performing a mixed-mode chromatography in bind-and-elute mode, or a hydrophobic interaction chromatography in flow-through mode, or a size-exclusion chromatography, and c) performing a weak cation exchange chromatography in bind-and-elute mode or flow-through mode, and thereby obtaining the polypeptide in monomeric form.

Abstract: Disclosed herein are methods that have been developed to control the formation of disulfide bonds between polypeptides of a multimeric protein produced by a bioprocess. Also disclosed are protein solution parameters that allow for controlling the formation of disulfide bonds. In one example, the methods disclosed herein can be used to control the proportion of half antibody molecules in an antibody solution.

Abstract: The present invention relates to a pharmaceutical preparation for treating an inflammatory condition, preferably a condition associated with ischemia comprising: a) a physiological solution comprising peripheral blood mononuclear cells (PBM-Cs) or a subset thereof, or b) a supernatant of the solution a), wherein the solution a) is obtainable by cultivating PBMCs or a subset thereof in a physiological solution free of PBMC-proliferating and PBMC-activating substances for at least 1 h.

Abstract: An osteogenic composition suitable for use in bone and soft tissue reparative procedures is provided for herein. Methods for preparing osteogenic composition from blood and bone marrow are also provided for. The osteogenic compositions contain therapeutically effective concentrations of one or more osteogenic agents such as BMP-2, TGF-?, PDGF and VEGF.

Abstract: The present invention pertains to methods of preventing and eliminating trisulfide bonds in proteins such as antibodies. In one embodiment, trisulfide bonds in proteins are converted to disulfide bonds as part of chromatographic purification procedures. In another embodiment, the formation of trisulfide bonds in proteins is inhibited by implementation of methods described herein during the cell culture production of such proteins. In another embodiment, monoclonal antibodies are produced by the methods described herein.

Abstract: Modified bovine G-CSF polypeptides and uses thereof are provided.

Abstract: Provided is a method for adjusting the balance of TNF-R1 and TNF-R2 in cells present at a target organ, tissue or site. In the adjustment method provided, when increasing the relative presence of TNF-R2 compared to the presence of TNF-R1 in the cells, a synthetic peptide is supplied to the cells, with the peptide being essentially made of at a TNF-R1 signal peptide motif or a modified amino acid sequence thereof; and when decreasing the relative presence of TNF-R2 compared to the presence of TNF-R1 in the cells, a synthetic peptide is supplied to the cells, with the peptide being essentially made of a TNF-R2 signal peptide motif or a modified amino acid sequence thereof.

Abstract: In certain aspects, the present disclosure relates to the insight that a polypeptide comprising a ligand-binding portion of the extracellular domain of activin-like kinase I (ALK1) polypeptide may be used to inhibit angiogenesis in vivo, particularly in mammals suffering angiogenesis-related disorders. Additionally, the disclosure demonstrates that inhibitors of ALK1 may be used to increase pericyte coverage in vascularized tissues, including tumors and the retina. The disclosure also identifies ligands for ALK1 and demonstrates that such ligands have pro-angiogenic activity, and describes antibodies that inhibit receptor-ligand interaction.

Abstract: The present invention provides an anti-human proBDNF monoclonal antibody, and uses thereof in pains. Specifically, the present invention provides uses of antibody polypeptide of tenth to 128th amino acid in a specific recognition pro-BDNF precursor protein structural domain, a nucleic acid sequence for coding the antibody polypeptide, a carrier comprising the nucleic acid sequence, a host comprising the carrier, a pharmaceutical composition comprising the antibody, and the antibody in the preparation of drugs used for alleviating and/or suppressing chronic pains.

Abstract: In vitro and in vivo application of sub-atmospheric, negative pressure on growth factor starting material, such as whole blood, extracts growth factors from the platelet granules of the growth factor starting material in a non-destructive medium without activating the clotting process. The extracted growth factors are released into a growth factor composition containing blood plasma, extracellular fluid or interstitial fluid depending upon the type and location of the growth factor starting material. The growth factors have a weight of about 70-76 kDaltons and are applied in either a filtered or unfiltered state topically to the area of a surface wound to effect healing. The extracted growth factors are also injected into soft tissue, such as a torn tendon, to promote tissue growth and healing. The growth factors are released in one method from a patient's own blood. In another method the growth factors are released from a whole blood source and freeze dried by lyophilization.

Abstract: According to one embodiment, a solid electrolyte secondary battery includes a positive electrode, a negative electrode, and a solid electrolyte layer, wherein at least one selected from the positive electrode and the negative electrode comprises active material particles, first solid electrolyte particles located the vicinity of a surface of the active material particles, and second solid electrolyte particles located a gap between the active material particles. A particle size ratio of a second solid electrolyte particle size D2 to a first solid electrolyte particle size D1 (D2/D1) satisfies the relation of 3<D2/D1<50, where D1 and D2 denote a particle size of the first and second solid electrolyte particles, respectively.

Abstract: Acute and chronic diseases of the organs are treated in patients using a rational, multi-tier approach. A patient can be pretreated with growth factor proteins or gene therapy, followed by the administration of adult stem cells or other cell therapy. The patient can be a fetus treated in utero or removed from the womb. The progress of treatment is monitored by ultrasound, MRI, CAT scan, cardiac echo, EEG, EKG, EMG or blood tests, with growth factor treatment and/or stem cell administration adjusted according to the results of the monitoring or clinical status of the patient.

Abstract: The invention describes compositions of peptide analogs that are active in blood or cleavable in blood to release an active peptide. The peptide analogs have a general formula: A-(Cm)x-Peptide (SEQ ID NO: 76), wherein A is hydrophobic moiety or a metal binding moiety, e.g., a chemical group or moiety containing 1) an alkyl group having 6 to 36 carbon units, 2) a nitrilotriacetic acid group, 3) an imidiodacetic acid group, or 4) a moiety of formula (ZyHisw)p (SEQ ID NO: 50), wherein Z is any amino acid residue other than histidine, His is histidine, y is an integer from 0-6; w is an integer from 1-6; and p is an integer from 1-6; wherein if A has alkyl group with 6 to 36 carbon units x is greater than 0; and Cm is a cleavable moiety consisting of glycine or alanine or lysine or arginine or N-Arginine or N-lysine, wherein x is an integer between 0-6 and N may be any amino acid or none. The peptide analogs are complexed with polymeric carrier to provide enhanced half-life.

Abstract: Modified animal erythropoietin polypeptides and uses thereof are provided.

Abstract: Disclosed herein are non-natural amino acids and polypeptides that include at least one non-natural amino acid of Formula (I), and methods for making such non-natural amino acids and polypeptides.

Abstract: The present invention provides a peptide-type compound which induces secretion of growth hormone and which has the activity of increasing the intracellular calcium ion concentration, wherein at least one amino acid is replaced by a modified amino acid and/or a non-amino acid compound, or a pharmaceutically acceptable salt thereof.

Abstract: Heparin binding peptides derived from a Tenascin (TNC) III1-5 domain or a fibrinogen ?15-66 domain have been found that bind certain cytokines with high affinity. Materials and methods for making compositions and devices using these peptides are disclosed.

Abstract: The present invention relates to a method for the isolation of proteins that comprise disulfide-bonds in their native conformation. Essentially, a method of the present makes the use of reducing agents such as ?-mercaptoethanol or dithiothreitol in protein isolation methods obsolete. A method of the present invention is particularly suitable for the isolation of precursor proteins such as proinsulin from recombinant cells.

Abstract: The present invention relates to an alphaviral replicase, especially Semliki Forest Virus replicase, or an expression vector encoding an alphaviral replicase, said alphaviral replicase comprising RNA dependent RNA polymerase activity, for use as an immune system modulating adjuvant. The alphaviral replicase may be used in the combination with a vaccine providing an adjuvant function therein, which when present therein will generate an additional boost to the immune response in the subject to whom this combination is administered as compared to when the vaccine alone is administered to a subject in need thereof. The aim of the present invention is to provide an efficient and easy to administer, species-independent adjuvant which will provide advantages to the adjuvants used together with vaccines today.

Abstract: The invention is a process for improved production of a recombinant mammalian protein by expression in a Pseudomonad, particularly in a Pseudomonas fluorescens organism. The process improves production of mammalian proteins, particularly human or human-derived proteins, over known expression systems such as E. coli in comparable circumstances Processes for improved production of isolated mammalian, particularly human, proteins are provided.

Abstract: Polypeptides comprising variant vascular endothelial growth factor sequences are provided. The polypeptides are useful in cancer imaging, cancer diagnosis, monitoring and treatment as well as treatment of diseases characterized by excessive neovascularization.

Abstract: The present invention concerns methods and compositions involving inhibitors of Pre-B Cell Colony Enhancing Factor (PBEF) for inflammatory conditions and diseases, including acute lung injury (ALI), ventilator-induced lung injury (VILI), and acute respiratory distress syndrome (ARDS). The present invention also concerns biomarkers for inflammation as well as methods for screening for PBEF inhibitors.

Abstract: This invention relates to the biotechnology area, and provides a kind of TRAIL chimeric protein, DNA sequence encoding this chimeric protein, vectors comprising this DNA, host cells or transgenic animals that contain one of the vectors, and preparation methods for the said chimeric protein and its applications. The said TRAIL fusion protein from the N to C terminal comprises human leucine zipper sequence, human TRAIL protein, human TRAIL extracellular domain or a fragment thereof. The chimeric protein has significantly enhanced stability, prolonged half-life in animals, increased efficacy and thus has broad application future.

Abstract: The invention provides compositions of novel high penetration compositions (HPC) or high penetration prodrugs (HPP) of peptides and peptide-related compounds, which are capable of crossing biological barriers with high penetration efficiency. The HPPs are capable of being converted to parent active drugs or drug metabolites after crossing the biological barrier and thus can render treatments for the conditions that the parent drugs or metabolites can. Additionally, the HPPs are capable of reaching areas that parent drugs may not be able to access or to render a sufficient concentration at the target areas and therefore render novel treatments. The HPPs can be administered to a subject through various administration routes, e.g., locally delivered to an action site of a condition with a high concentration or systematically administered to a biological subject and enter the general circulation with a faster rate.

Abstract: The invention relates to methods of preventing or inhibiting the onset and/or treating autoimmune demyelinating neuropathy and other autoimmune or inflammatory diseases involving macrophage infiltration.

Abstract: A method of detecting proliferative diseases causing sclerosis, comprising measuring the expression of at least one substance selected from the group consisting of STAT3, phosphorylated STAT3, Smad1, phosphorylated Smad1, activin receptor-like kinase 1, activin receptor-like kinase 3 and bone morphogenetic proteins in a biological sample. A kit therefor. A prophylactic and/or therapeutic agent for proliferative diseases causing sclerosis, comprising as an active ingredient a substance having an inhibitory effect on the expression of at least one substance selected from the group consisting of STAT3, phosphorylated STAT3, Smad1 and phosphorylated Smad1. A method of identifying substances effective in preventing and/or treating proliferative diseases causing sclerosis, comprising judging whether or not a test substance inhibits the expression of at least one substance selected from the group consisting of STAT3, phosphorylated STAT3, Smad1 and phosphorylated Smad1. A kit therefor.

Abstract: Disclosed is a method for refolding a protein or peptide that does not contain essential disulfides and that contains at least one free cysteine residue. Also disclosed are polymer IFN-? conjugates that have been created by the chemical coupling of polymers such as polyethylene glycol moieties to IFN-?, particularly via a free cysteine in the protein. Also disclosed are analogs of bioactive peptides that may be used to create longer acting versions of the peptides, including analogs of glucagon, glucagon-like peptide-1 (GLP-1), GLP-2, Gastric inhibitory peptide (GIP), PYY, exendin, ghrelin, gastrin, amylin, and oxyntomodulin.

Abstract: Culture media comprising manganese and methods of culturing cells to improve sialylation and glycosylation of glycoproteins are provided.

Abstract: The invention provides compositions of novel high penetration compositions (HPC) or high penetration prodrugs (HPP) of peptides and peptide-related compounds, which are capable of crossing biological barriers with higher penetration efficiency comparing to their parent drugs. The HPPs are capable of being converted to parent drugs or drug metabolites after crossing the biological barrier and thus can render treatments for the conditions that the parent drugs or metabolites can. Additionally, the HPPs/HPCs are capable of reaching areas that parent drugs may not be able to access or to render a sufficient concentration at the target areas and therefore render novel treatments. The HPPs/HPCs can be administered to a subject through various administration routes, e.g., locally delivered to an action site of a condition with a high concentration or systematically administered to a biological subject and enter the general circulation with a faster rate.

Abstract: The present technology relates to engineered human Fibroblast Growth Factor-2 (FGF2) proteins and methods of using the same. In particular, the methods and compositions relate to FGF2 mutants with increased thermostability compared to the wild-type protein and method for using the proteins in the culturing of embryonic stem cells.

Abstract: It has been discovered that vascular endothelial growth factor (“VEGF”) promotes migration of activated (but not differentiating) keratinocytes to skin. This growth factor specifically increases migration of keratinocytes of the “wounded skin” phenotype but does not have significant effects upon differentiated keratinocytes. It also increases collagen deposition and reduces wrinkles, enhances skin quality, and increases skin thickness to normal levels in individuals where skin has thinned due to age or disorder such as diabetes. It is particularly well suited for use as cosmeceuticals when applied in purified form and in known amounts. The data presented in the examples demonstrate efficacy and specificity of VEGF in enhancing migration of normal human keratinocytes as well as formation of new granulation tissue including collagen formation. VEGF induces keratinocyte and fibroblast migration, formation of new tissue, and not only induces deposition of collagen but improves alignment of the collagen fibers.

Abstract: The present invention relates to novel therapies for treatment of new and existing type 1 and type 2 diabetes, PreDiabetes, Latent Autoimmune Diabetes of Adulthood, and diseases of insulin deficiency, beta cell deficiency, insulin resistance and impaired glucose metabolism. In particular, the present invention identifies common peptides within the human Reg1a, Reg1b, Reg3a and Reg4, as signaling peptides for beta cell generation acting through the human Reg Receptor on the surface of human pancreatic extra-islet tissue.

Abstract: Peptide antagonists of ?c-family cytokines, Interleukin (IL)-2, IL-4, IL-7, IL-9, IL-15, and IL-21 are described. The ?c-cytokines are associated with important human diseases, such as leukemia, autoimmune diseases, collagen diseases, diabetes mellitus, skin diseases, degenerative neuronal diseases and graft-versus-host disease (GvHD). Thus, inhibitors of ?c-cytokine activity are valuable therapeutic, cosmetic agents and research tools. Traditional approaches to inhibiting ?c-cytokine activity involve raising neutralizing antibodies against each individual ?c-cytokine family member/receptor subunit. However, success has been limited and often multiple ?c-cytokine family members co-operate to cause the disease state. Combinatorial use of neutralizing antibodies raised against each factor is impractical and poses an increased risk of adverse immune reactions. To overcome these shortcomings, use of peptide antagonists based on the consensus ?c-subunit binding site to inhibit ?c-cytokine activity is provided.

Abstract: Modified VEGF proteins that inhibit VEGF-mediated activation or proliferation of endothelial cells are disclosed. The analogs may be used to inhibit VEGF-mediated activation of endothelial cells in angiogenesis-associated diseases such as cancer, inflammatory diseases, eye diseases, and skin disorders.

Abstract: This invention relates to a compound that induces or activates telomerase activity based on the nucleotide sequence of the GSE 24.2 fragment of dyskerin or the protein or peptide sequence encoded by said nucleotide sequence. Another part of the invention relates to vectors that comprise said sequence and cells transformed thereby, and pharmaceutical compositions that contain all these elements. These compositions may be used in the treatment of diseases from the following group: ageing or acceleration of ageing, neurodegenerative diseases and dyskeratosis congenita.

Abstract: The invention provides use of a TSG-6 polypeptide, or a polynucleotide encoding an TSG-6 polypeptide, in the manufacture of a medicament for the treatment or prevention of a bone disease or condition associated with bone resorption by osteoclasts.

Abstract: LEDGF peptides with anti-protein aggregation activity and methods of use are provided. The LEDGF peptides disclosed herein demonstrate an ability to treat degenerative diseases and diseases with various cellular stresses including oxidative stress and protein-aggregation stress. In addition, extended release formulations, including formulations suitable for ophthalmic administration are provided.

Abstract: The present invention is based in part on the discovery of brown and white fat cell specific surface markers. It has been found that the small amino acid transporter Slca10/Asc1 is a specific surface marker for white adipocytes and that the ligand-gated ion channel P2X5 and the small amino acid transporter Slc36a2 are specific surface markers for brown adipocytes. Having identified these specific white and brown cell surface markers, the present invention provides compositions and methods suitable for the targeting of any number of agents to a white or brown adipose tissue and the identification and isolation of white or brown adipocytes for any number of uses including therapeutic, screening and diagnostic purposes.