The development and optimization of a purification process of monoclonal antibodies based on two continuous chromatography steps for capture and intermediate purification are presented. The two chromatography steps were individually optimized using either batch chromatography or sequential multicolumn chromatography (SMCC). Proprietary simulation software was used to optimize SMCC and to evaluate the potential gains compared with batch chromatography. The SMCC recipes provided by the simulation software were evaluated experimentally. A good correlation was found between the simulated results and experimental observations. Significant gains were observed on the productivity, buffer consumption and the volume of resin required for SMCC over batch chromatography. Based on these results, a chained process from the capture to polishing steps was implemented. This chained process demonstrated significantly better performance compared with the batch equivalent while satisfying the specifications. The expected positive impact provided by implementing continuous chromatography is also discussed.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.jbiotec.2015.04.026 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Nitroimidazoles in Albanian honey samples by LC-MS/MS analysis.
Food Addit Contam Part B Surveill
January 2025
Department of Chemical Sciences, Ariel University, Ariel, Israel.
This study employed QuEChERS extraction method combined with liquid chromatography-tandem mass spectrometry (LC-MS/MS) to analyse honey samples from Albania for nitroimidazole residues. This approach allowed for the detection of trace-level residues, achieving sensitivity in the parts per billion range. Out of the 45 honey samples analysed, 6 exceeded the European Union's safety limit of 1 µg/kg, with metronidazole (MNZ) and dimetridazole (DMZ) being the predominant contaminants.
View Article and Find Full Text PDFAssociation of methotrexate polyglutamates concentration with methotrexate efficacy and safety in patients with rheumatoid arthritis treated with predefined dose: results from the MIRACLE trial.
Ann Rheum Dis
January 2025
Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan. Electronic address:
Objectives: The usefulness of methotrexate-polyglutamates (MTX-PGs) concentration for management of rheumatoid arthritis has been debated. We aimed to clarify the association of MTX-PGs concentration with efficacy and safety in MTX-naïve patients initiating MTX in a prospective interventional clinical trial.
Methods: The MIRACLE trial enrolled 300 MTX-naïve patients.
Resistance Analyses in Heavily Treatment-Experienced People with HIV Treated with the Novel HIV Capsid Inhibitor Lenacapavir After 2 years.
J Infect Dis
January 2025
Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA, 94404 USA.
Background: Lenacapavir is a highly potent first-in-class inhibitor of HIV-1 capsid approved for the treatment of heavily treatment-experienced (HTE) people with HIV-1 (PWH) harboring multidrug resistant (MDR) virus, in combination with an optimized background regimen (OBR). Resistance analyses conducted after 2 years of lenacapavir treatment in the phase 2/3 CAPELLA study are described.
Methods: CAPELLA enrolled viremic HTE PWH with resistance to 2 or more drugs per class in at least 3 of the 4 main drug classes.
Pharmacokinetics and pharmacodynamics of ciprofol after continuous infusion in elderly patients.
BMC Anesthesiol
January 2025
Department of Anesthesiology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), 54 Youdian Road, Hangzhou, 310006, China.
Background: Ciprofol, a novel intravenous anesthetic, which has primarily been used for the induction and maintenance of general anesthesia in adults, is characterized by rapid onset, short duration of action, and quick and smooth recovery. However, the pharmacokinetic characteristics of continuous infusions and the correlation between the plasma concentration and the bispectral index (BIS) in elderly patients are still unknown.
Method: In this randomized, controlled study, thirty elderly patients (62-78 years old) undergoing elective gastrointestinal tumor resection were treated with propofol (N = 15) or ciprofol (N = 15) as sedatives during anesthesia.
Toxicological evaluation, postmortem case descriptions, and pharmacological activity of N,N-dimethylpentylone and related analogues.
J Anal Toxicol
January 2025
Center for Forensic Science Research and Education, Fredric Rieders Family Foundation, Horsham, PA.
Identification of N,N-dimethylpentylone (DMP) in counterfeit "Ecstasy" and "Molly" tablets poses risk to public health due to its adverse effects. Little information is available regarding the pharmacological activity or relevant blood or tissue concentrations of DMP, and even less is known about other structurally related beta-keto methylenedioxyamphetamine analogues on recreational drug markets, such as N-propyl butylone. Here, a novel toxicological assay utilizing liquid chromatography-tandem quadrupole mass spectrometry (LC-QQQ-MS) was developed and validated for the quantitation of DMP and five related synthetic cathinones (eutylone, pentylone, N-ethyl pentylone (NEP), N-propyl butylone, and N-cyclohexyl butylone), with chromatographic resolution from isomeric variants and quantitation performed by standard addition.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!