Rapid Development of High Concentration Protein Formulation Driven by High-Throughput Technologies.

Background: High concentration protein formulation (HCPF) development needs to balance protein stability attributes such as conformational/colloidal stability, chemical stability, and solution properties such as viscosity and osmolality.

Methodology: A three-phase design is established in this work. In Phase 1, conformational and colloidal stability are measured by 384-well-based high-throughput (HT) biophysical screening while viscosity reduction screening is performed with HT viscosity screening.

Leveraging high-throughput analytics and automation to rapidly develop high-concentration mAb formulations: integrated excipient compatibility and viscosity screening.

Background: Formulation screening is essential to experimentally balance stability and viscosity in high-concentration mAb formulations. We developed a high-throughput approach with automated sample preparation and analytical workflows to enable the integrated assessment of excipient compatibility and viscosity of mAb formulations.

Methods: Ninety-six formulations of a trastuzumab biosimilar were screened by combining 8 types of excipient modifiers with 4 types of buffers across a pH range of 4.

Intra-Rater and Inter-Rater Reliability of Tongue Coating Diagnosis in Traditional Chinese Medicine Using Smartphones: Quasi-Delphi Study.

Background: There is a growing trend in the use of mobile health (mHealth) technologies in traditional Chinese medicine (TCM) and telemedicine, especially during the coronavirus disease (COVID-19) outbreak. Tongue diagnosis is an important component of TCM, but also plays a role in Western medicine, for example in dermatology. However, the procedure of obtaining tongue images has not been standardized and the reliability of tongue diagnosis by smartphone tongue images has yet to be evaluated.

Rapid global characterization of immunoglobulin G1 following oxidative stress.

Although peroxide and leachable metal-induced chemical modifications are among the most important quality attributes in bioprocess development, there is no mainstream characterization method covering all common modifications theoretically possible on therapeutic proteins that also gives consistent results quickly. Here, we describe a method for rapid and consistent global characterization of leachable metals- or peroxide-stressed immunoglobulin (Ig) G1 monoclonal antibodies (mAbs). Using two independent protease digestions, data-independent acquisition and data-dependent acquisition liquid chromatography high-resolution mass spectrometry, we monitored 55 potential chemical modifications on trastuzumab, a humanized IgG1 mAb.

Intracellular labeling of TiO nanoparticles for fluorescence microscopy detection.

Titanium dioxide (TiO) nanoparticles are produced for many different purposes, including development of therapeutic and diagnostic nanoparticles for cancer detection and treatment, drug delivery, induction of DNA double-strand breaks, and imaging of specific cells and subcellular structures. Currently, the use of optical microscopy, an imaging technique most accessible to biology and medical pathology, to detect TiO nanoparticles in cells and tissues is limited with low detection limits, while more sensitive imaging methods (transmission electron microscopy, X-ray fluorescence microscopy, etc.) have low throughput and technical and operational complications.

Distribution of Iron Oxide Core-Titanium Dioxide Shell Nanoparticles in VX2 Tumor Bearing Rabbits Introduced by Two Different Delivery Modalities.

This work compares intravenous (IV) versus fluoroscopy-guided transarterial intra-catheter (IC) delivery of iron oxide core-titanium dioxide shell nanoparticles (NPs) in vivo in VX2 model of liver cancer in rabbits. NPs coated with glucose and decorated with a peptide sequence from cortactin were administered to animals with developed VX2 liver cancer. Two hours after NPs delivery tumors, normal liver, kidney, lung and spleen tissues were harvested and used for a series on histological and elemental analysis tests.

[Value of detecting epidermal growth factor receptor mutations in non-small cell lung cancer tissue by TaqMan-amplification refractory mutation system].

Objective: To explore the value of detecting mutations on epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) tissue by TaqMan-amplification refractory mutation system (TaqMan-ARMS).

Methods: TaqMan-ARMS and DNA sequencing were used to detect the EGFR exon 19 and 21 mutations in tumor tissues and the samples collected from 199 patients at 4 different 3A hospitals in Beijing from January 2008 to March 2011.

Results: The rate of mutations in EGFR exon 19 and 21 was 19.

[Acupoint-injection of BCG polysaccharide nuclear acid for treatment of condyloma acuminatum and its immunoregulatory action on the patient].

Objective: To probe into immunological mechanisms and clinical therapeutic effect of acupoint-injection of BCG polysaccharide nuclear acid (BCG-PSN) for treatment of condyloma acuminatum (CA).

Methods: Two hundred cases were randomly divided into 4 groups. After removed the CA by laser, the treatment group (group A) was treated with acupoint-injection of BCG-PSN, the control group I (group B) with intramuscular injection of BCG-PSN, the control group II (group C) with intramuscular injection of interferon, and the blank control group (group D) with no treatment.

Effects of CT-localized scalp round-needling on the blood rheology, NO and NOS of patients with multiple infarctional dementia.

Objective: To observe the short-term therapeutic effects of CT-localized scalp round-needling on the blood rheology, nitric oxide (NO) and nitric oxide synthetase (NOS) of patients with multiple infarctional dementia.

Methods: 89 cases of multiple infarctional dementia were randomly divided into an electro-round-needling group (57 cases), and a western medication group (32 cases). The therapeutic effects, including the effects on the blood rheology, NO and NOS, were observed.

Effects of the combined therapy of acupuncture with herbal drugs on male immune infertility--a clinical report of 50 cases.

Unlabelled: To study the clinical effects of the combined therapy of acupuncture with herbal drugs on male immune infertility and on antisperm antibody (AsAb), 100 male cases of infertility with positive AsAb were divided randomly into two groups, each consisting of 50 cases. The acupuncture-drug group was treated with acupuncture on Ganshu (BL 18), Shenshu (BL 23), Taichong (LR 3), Taixi (KI 3), Xinshu (BL 15), Geshu (BL 17), Shenmen (HT 7), and Xuehai (SP 10), combined with oral medication of Liuwei Dihuang Wan (Bolus of the Six Drugs Including Rehmanniae). The control group was treated with oral prednisone.

[Observation on efficacy of CT positioning scalp circum-needling combined with Chinese herbal medicine in treating poly-infarctional vascular dementia].

Objective: To observe the short-term effect of patients with poly-infarctional vascular dementia (PIVD) treated by CT positioning scalp circum-needling (SCN) combined with Chinese herbal medicine.

Methods: Eighty-nine patients of PIVD were enrolled and divided into the treated group (n = 57) and the control group (n = 32). They were all treated with oral taking of Fuyuan mixture (FYM, consisted of ginseng, medlar, salvia, bitter cardamon, etc).