Development and validation study for the chromatographic purification process for tetanus anatoxin on Sephacryl S-200 High Resolution.

S M Prado; M D Vancetto; J M de Oliveira; F Fratelli; H G Higashi

PubMed · 10597658

Development and validation study for the chromatographic purification process for tetanus anatoxin on Sephacryl S-200 High Resolution.

S M Prado·M D Vancetto·J M de Oliveira·F Fratelli·H G Higashi

Abstract

The tetanus purified anatoxin is used in the preparation of multiple immunoprophylactics. WHO (World Health Organization) specifies that the tetanus anatoxin must exhibit a degree of purity greater than or equal to 1,000 Lf/mg protein nitrogen (PN). Today liquid chromatography is a well established technique for the purification of tetanus anatoxin and several different methods are used in production scale. On a small scale, we purified tetanus anatoxin on Sephacryl S-200 High Resolution (gel filtration) and we obtained a successful high-yield purification. On the basis of these results, by combining conventional tangential flow filtration (TFF) at 50,000 N.M.W.L. (Nominal Molecular Weight Limit) ultrafiltration membrane with gel filtration on Sephacryl S-200 High Resolution, we have been able to purify 14 lots of tetanus anatoxin using the Bioprocess System (Amersham Pharmacia Biotech) to a large scale operation. Using this method, 77,401,332 doses of tetanus toxoid were prepared in 14 consecutive lots, supporting the reproducibility and reliability of the method presented here.

Explore related subjects

Acrylic Resins Chromatography, Ion Exchange Drug Industry Molecular Weight Tetanus Toxin Journal Article

Keep this discovery

Explore connections, maps & timelines

BibTeX RIS

S M Prado, M D Vancetto, J M de Oliveira, F Fratelli, H G Higashi. Development and validation study for the chromatographic purification process for tetanus anatoxin on Sephacryl S-200 High Resolution.. https://pubmed.ncbi.nlm.nih.gov/10597658/

Cite the original work for its findings. Save a collection to share your selection of sources.

KEEP EXPLORING

Related citations

PubMed2007

Calcium polycarbophil improves constipation in primary autonomic failure and multiple system atrophy subjects.

Explore the source record for details and available documents.

Acrylic Resins↗

PubMed2007

Influence of the activator in an acrylic bone cement on an array of cement properties.

In all but one of the acrylic bone cement brands used in cemented arthroplasties, N,N-dimethyl-4-toluidine (DMPT) serves as the activator of the polymerization reaction. However, many concerns have been raised about this activator, all related to its toxicity. Thus, various workers have assessed a number of alternative activators, with two examples being N,N-dimethylamino-4-benzyl laurate (DMAL) and N,N-dimethylamino-4-benzyl oleate (DMAO). The results of limited characterization of cements that contain DMAL or DMAO have been reported in the literature. The present work is a comprehensive comparison of cements that contain one of these three activators, in which the values of a large array of their properties were determined. These properties range from the setting time and maximum exotherm temperature of the curing cement to the variation of the loss elastic modulus of the cured cement with frequency of the applied indenting force in dynamic nanoindentation tests. The present results, taken in conjunction with those presented in previous reports by the present authors and co-workers on other properties of these cements, indicate that both DMAL and DMPT are suitable alternatives to DMPT.

Acrylic Resins↗

PubMed2007

Dynamic scaling of polymer gels comprising nanoparticles.

We present dynamic light scattering (DLS) measurements of soft poly(methyl-methacrylate) (PMMA) and polyacrylamide (PA) polymer gels prepared with trapped bodies (latex spheres or magnetic nanoparticles). We show that the anomalous diffusivity of the trapped particles can be analyzed in terms of a fractal Gaussian network gel model for the entire time range probed by DLS technique. This model is a generalization of the Rouse model for linear chains extended for structures with power law network connectivity scaling, which includes both percolating and uniform bulk gel limits. For a dilute dispersion of strongly scattering particles trapped in a gel, the scattered electric field correlation function at small wavevector ideally probes self-diffusion of gel portions imprisoning the particles. Our results show that the time-dependent diffusion coefficients calculated from the correlation functions change from a free diffusion regime at short times to an anomalous subdiffusive regime at long times (increasingly arrested displacement). The characteristic time of transition between these regimes depends on scattering vector as approximately q(-2), while the time decay power exponent tends to the value expected for a bulk network at small q. The diffusion curves for all scattering vectors and all samples were scaled to a single master curve.

Acrylic Resins↗