BioProcessing Journal

Analysis of Downstream Process Controls to Assure the Quality of Recombinant Granulocyte-Colony Stimulating Factor

Human granulocyte colony-stimulating factor (GCSF) is produced by biotech laboratories and production facilities for reducing neutropenia duration and sequels in patients with myelosuppressor treatments, among other applications. However, real challenges for these laboratories started in 2015 when the PEGylated-GCSF patent expired, opening alternatives for developing biomanufacturing processes and new applications. Thus, the purpose of this study was to analyze downstream process controls designed to ensure recombinant human GCSF (rh-GCSF) quality and to provide some evidence of the downstream process validation status. Study outcomes proved that the rh-GCSF expression system was stable and chromatographic profiles were reproducible among samples.

Analytics Biologics Biologics Production Downstream production Regulatory Risk Analysis and Management

cho cells downstream processes e. coli cells granulocyte gscf host cell protein recombinant proteins rh-gcsf production

Evaluation of Disinfection Procedures for Control of Potential Contamination of Biologicals

An effective disinfection program is an essential component of a pharmaceutical/biopharmaceutical manufacturer’s contamination control strategy. A good disinfection program can help prevent microbial or viral contamination of the manufactured product, further ensuring product safety for patients. The term disinfection is often used interchangeably with cleaning, but the purpose of disinfection is quite different from that of cleaning. Disinfection of a surface will result in inactivation of infectious agents such as bacteria, fungi, and viruses, whereas cleaning a surface removes soil, debris, and other residues.

Analytics Biologics Regulatory Risk Analysis and Management

biologicals disinfection challenge microbe contamination control strategy disinfection strategies infectious agents spike controls viral inactivation

The Development of a Flow-Through Mode Cation Exchange Process for the Purification of a Monoclonal Antibody

Cation exchange chromatography is typically utilized in bind-and-elute mode for monoclonal antibody purification. However, during purification process development for a novel monoclonal antibody (MAb) intended for clinical use, it was determined that bind-and-elute conditions were not sufficient for removing significant levels of antibody aggregate. Based on preliminary purification data, an alternative purification method, operation of the cation exchange process in flow-through mode, was investigated.

Analytics Biologics Pre-Clinical Development Research

cation exchange chromatography cex cho cells design-of-experiments doe flow-through mode mab monoclonal antibody polishing step chromatography protein purification

The Use of Signal Filtering Algorithms in Bioreactor Characterisation and Monitoring Using Raman Spectroscopy

Raman spectroscopy offers an attractive solution for monitoring key process parameters and predictive modelling in cell culture processes using transgenic Chinese hamster ovary (CHO) cells. Frequent in-line measurements offer the potential for advanced control strategies. However, an erroneous value created by analytical signal noise is a significant issue that can affect process controls negatively. One such challenge is to differentiate the signal reflecting process changes, ranging from random to gross error, in a timely manner so the process control system can respond to these changes and maintain adequate control.

Analytics Biologics Biologics Production Pre-Clinical Development Research

cho cells mammalian cell culture raman spectroscopy signal filtering algorithm

Glucagon-Like Peptide 1 Synthesis for Use in Human Diabetes Treatment

Type 2 diabetes is a major risk factor for cardiovascular disease-related morbidity and mortality. There are several therapies for type 2 diabetes management, but optimal glycemic control has not been achieved yet. A large number of patients fail to attain an ideal glycemic target, and only a few drugs have demonstrated effective control of glycated hemoglobin (HbA1c) numbers below 7%. The biggest hurdles for implementing long-term, effective therapies are hypoglycemia and weight gain. Most pharmaceuticals currently available act to increase insulin availability through administration, secretion, or by increasing insulin sensitivity. Others act by delaying the delivery and absorption of carbohydrates from the gastrointestinal (GI) tract or by increasing urinary glucose excretion.

Biologics Biologics Production Pre-Clinical Development Research

GLP-1 polypeptides synthesized GLP-1

Coming ‘Round to Spheroid Culture

Cells cultured in 2D can differ in terms of both physiology and cellular responses compared with cells in vivo. This has led to a surge in the popularity of using 3D culture techniques as mounting evidence suggests that culturing cells in 3D is more representative of the in vivo environment, even to the extent that the gene expression profiles of cells from 3D cultures more accurately reflect clinical expression profiles than those observed in 2D cultures. 3D culture offers the potential for more accurate models of drug delivery and efficacy, as well as numerous clinical and research applications, and is becoming increasingly capable of integrating into high-throughput activities. Spheroids, or sphere cultures, have become an especially exciting area of 3D in vitro culture due to their great potential for use in studies that investigate growth and function of both malignant and normal tissues. These sphere cultures have contributed considerably to our knowledge of cellular responses thanks to the accuracy with which they reflect the in vivo system.

Biologics Biologics Production Cell Lines Pre-Clinical Development Research

2d cells 3d cells cell culture cho cells spheroids

Next Generation Vaccines: Development of a Novel Streptococcus pneumoniae Multivalent Protein Vaccine

Polysaccharide-based vaccines are widely used to protect against Streptococcus pneumoniae (S. pneumoniae) infections in infants and the elderly. However, their use is limited by strain specificity, which restricts both their geographical and economical utility. There is an urgent need for protein-based vaccines that are likely to provide broader, more economical protection against the global burden of pneumococcal disease. In this paper, we describe the pre-clinical development of a multi-subunit protein vaccine that can be manufactured efficiently and economically to meet this need. Genetically engineered Streptococcus pneumoniae TIGR4 B7.1 PlyD6 cell substrate was constructed to deliver non-toxic Ply.

Biologics Biologics Production Cell Lines Pre-Clinical Development

multi-subunit protein pcv-13 pnubiovax polysaccharide-based vaccines S. pneumoniae vaccines TIGR4

Selection of Clarification Methods for Improved Downstream Performance and Economics

The production of biopharmaceutical drugs typically involves a biological expression within a bacterial, yeast, or mammalian cell expansion system. Getting to the final product requires multiple purification steps, from primary clarification to the final formulation and sterile filtration. The aim of the initial purification steps is not to purify the stream perfectly but rather, to prepare the stream for finer and more specific purification steps further downstream. Apart from efficiently removing contaminants, the clarification stages also need to maintain high product recovery whilst being consistent and robust.

Baculovirus Expression Technology Bioinformatics Biologics Biologics Production Cell Lines Process Automation Quality Risk Management (QRM) Regulatory Research

aex polishing biologics biopharmaceuticals cex purification clarification depth filtration downstream economics downstream performance hcp hic host cell proteins hydrophobic interaction chromatography

A Qualitative Risk-Benefit Structure for Developing and Manufacturing Biopharmaceuticals

Biopharmaceutical manufacturing will continue to be increasingly challenging as medical knowledge and understanding rapidly advance. Many new therapies and products will utilize cellular, viral, genetic, and epigenetic approaches along with a repertoire of increasingly complex proteins targeting a rapidly increasing inventory of newly discovered biomarkers. Manufacturing these products efficiently, consistently, and reliably will require sophisticated manufacturing approaches, methods, and controls. In addition, growing patient, societal, and even regulatory pressures demand that new therapeutics be developed and manufactured quickly, reliably, and efficiently.

Bioinformatics Biologics Biologics Production Quality Risk Management (QRM) Regulatory Research

12cfr211 achieving manufacturing excellence amps appropriate manufacturing practices bioburden control cgmp critical quality attributes generalized risk structure GMP ichq7a ichq8 ichq9 manufacturing enterprise

Achieving Excellence in Biopharmaceutical Development and Manufacturing by Using Appropriate Manufacturing Practices (AMPs)

Bioinformatics Biologics Biologics Production Quality Risk Management (QRM) Regulatory Research

12cfr211 achieving manufacturing excellence amps appropriate manufacturing practices bioburden control cgmp GMP ichq7a ichq9

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