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

by Paola Cecchini, Claire Entwisle, Michael Joachim, Yin Pang, Kate A. Dalton, Sue Hill, Ann McIlgorm, Win-Yan Chan, Jeremy S. Brown, Camilo A. Colaco, Chris R. Bailey, and Sue W. Clarke
Volume 14, Issue 3 (Fall 2015)

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. PnuBioVax™ S. pneumoniae vaccines were produced at ImmBio in a 1 L-scale fermenter as development batches. The process has been successfully “tech transferred” to a CMO for scale-up and production of toxicology and clinical supplies. Pre-clinical immunogenicity tests showed promising results for PnuBioVax. Rabbit sera generated by PnuBioVax were able to produce surface binding antibody and complement-mediated killing of S. pneumoniae for both TIGR4 and the heterologous strain 15B (not covered by pneumococcal conjugate vaccine [PCV]-13). No overall benefit to the immunogenicity by the addition of Alhydrogel was seen in the total IgG response. In passive protection studies in mice, serum raised against PnuBioVax in rabbits protected against challenge by S. pneumoniae TIGR4...

Citation:
Cecchini P, Entwisle C, Joachim M, Pang Y, Dalton KA, Hill S, McIlgorm A, Chan W-Y, Brown JS, Colaco CA, Bailey CR, Clarke SW. Next generation vaccines: development of a novel Streptococcus pneumoniae multivalent protein vaccine. BioProcess J, 2015; 14(3): 18–33. http://dx.doi.org/10.12665/J143.Colaco.

Posted online October 9, 2015.

 
Coming ‘Round to Spheroid Culture

by Bhaskar S. Mandavilli, Cindy Neeley, MaryKay Bates, and Magnus Persmark
Volume 14, Issue 3 (Fall 2015)

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. This is primarily a result of the fact that cells do not normally grow or interact in isolation, but instead form complex interactions with other cells and the surrounding microenvironment. Thus, the creation of a 3D environment that incorporates spheroids closely mimics in vivo, allowing researchers to incorporate cell-cell interactions, nutrient gradients, and diffusion kinetics in their in vitro models. Researchers have been making use of these culture methods across multiple fields for a number of years and have made considerable contributions to our knowledge of cellular interactions and behaviors. Spheroids offer particular benefits in cancer biology where they contribute immense value in examining the growth and behavior of tumors since they share several key histomorphological and functional traits that include the formation of cell-cell contacts, decreased proliferation, increased survival rates, and a hypoxic core...

Citation:
Mandavilli BS, Neeley C, Bates M, Persmark M. Coming ‘round to spheroid culture. BioProcess J, 2015; 14(3): 44–9. http://dx.doi.org/10.12665/J143.Persmark.

Posted online October 9, 2015.

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

by Archana Gangakhedkar and Jyothi Thundimadathil
Volume 14, Issue 3 (Fall 2015)

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. Recent advances in type 2 diabetes management include the clinical development of dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagon-like peptide 1 (GLP-1) receptor agonists. GLP-1 belongs to the hormonal family of incretins that enhance the secretion of insulin. Incretins lower blood glucose levels by stimulating pancreatic beta cells to release increased amounts of insulin. The two primary incretin hormones are GLP-1 and glucose-dependent insulinotropic polypeptide (GIP), also known as gastric inhibitory polypeptide. Both GLP-1 and GIP are rapidly cleaved by DPP-4. GLP-1 is a product of a precursor molecule called pre-proglucagon, a polypeptide which is split to produce many hormones including glucagon. As they have the same origin, these hormones share some similarities, and hence the name “glucagon-like”...

Citation:
Gangakhedkar A, Thundimadathil J. Glucagon-like peptide 1 synthesis for use in human diabetes treatment. BioProcess J, 2015; 14(3): 13–7. http://dx.doi.org/10.12665/J143.Gangakhedkar.

Posted online October 9, 2015.

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

by Giuseppe Elia, Dylan Jones, Matthew Harding, and Chris Whitmore
Volume 14, Issue 3 (Fall 2015)

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. The frequency of measurement acquisition in Raman monitoring makes signal filtering a viable solution to the problem of erroneous measurements. In this study, partial least squares (PLS) models were developed for multiple process parameters (such as glucose, glutamate, and viable cell density) using data from a 10 L bioreactor. The PLS models were applied to over 10,000 spectra taken at approximately five-minute intervals. Signal filters were applied to clean the resulting prediction data. The resulting predictions showed far fewer fluctuations from random errors, as well as greater resistance to gross (malfunction-based) errors, than the non-filtered prediction data. Effective signal filtering could represent a major improvement in the reliability of in-line spectroscopic monitoring of bioreactor processes and greatly improve the potential for robust control strategies on those processes...

Citation:
Elia G, Jones D, Harding M, Whitmore C. The use of signal filtering algorithms in bioreactor characterisation and monitoring using Raman spectroscopy. BioProcess J, 2015; 14(3): 34–43. http://dx.doi.org/10.12665/J143.Elia.

Posted online October 9, 2015.

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

by Rachel B. Wollacott, PhD, Lauren E. Roth, PhD, Tracy L. Sears, Rebecca A. Sharpe, Monica Jiang, and Sadettin S. Ozturk, PhD
Volume 14, Issue 2 (Summer 2015)

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. Flow-through mode cation exchange conditions were optimized by design of experiments. Optimal conditions resulted in <1% dimer and >85% recovery at all scales evaluated. An additional anion exchange polishing step was required to remove residual process impurities. The possibility of using the flow-through mode, cation exchange approach as a platform process, as well as the benefits and drawbacks of operating the cation exchange process in flow-through mode for MAb purification are discussed...

Citation:
Wollacott RB, Roth LE, Sears TL, Sharpe RA, Jiang M, Ozturk SS. The development of a flow-through mode cation exchange process for the purification of a monoclonal antibody. BioProcess J, 2015; 14(2): 5–13. http://dx.doi.org/10.12665/J142.Wollacott.

Posted online July 10, 2015.

 
Evaluation of Disinfection Procedures for Control of Potential Contamination of Biologicals

by Kathryn Martin Remington, PhD and Marian L. McKee, PhD
Volume 14, Issue 2 (Summer 2015)

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. A dirty surface that contains soil or cleaner/disinfectant residues can complicate disinfection or even contain infectious agents, yet a visibly clean surface may still require disinfection. Cleaning and disinfection programs complement each other. In contrast to a cleaning procedure, the effectiveness of a disinfection procedure is dependent on factors such as the type of disinfectant used, the application method, and contact time...

Citation:
Remington KM, McKee ML. Evaluation of disinfection procedures for control of potential contamination of biologicals. BioProcess J, 2015; 14(2): 14–21. http://dx.doi.org/10.12665/J142.Remington.

Posted online July 10, 2015.

 
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