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Development and Scale-Up of a Continuous Reaction for Production of an Active Pharmaceutical Ingredient Intermediate

FLOW CHEMISTRY, flow synthesis Comments Off

Aug 242018

Flow reactor equipment that was used in the piloting of the aldol flow chemistry. (a) The tube-in-shell heat exchangers were used to control stream temperature upstream and downstream of the (b) Y-mixer. Valves and ports on Y-mixer enabled flushing of lines and incorporation of inline thermocouples.

Examples of continuous flow reactions in the laboratory setting are becoming commonplace in pharmaceutical drug substance research. Developing these processes for robust commercialization and identifying the scale-up parameters remains a challenge. An aldol reaction in the formation of an active pharmaceutical ingredient intermediate was developed in flow at the milliliter scale. Research focused on identifying conditions that led to robust and stable operating conditions. Desired reaction performance was achieved in various mixers across reactor scales by identifying conditions that led to similar flow regimes. Conditions from the lab were transferred to the pilot plant to successfully process ∼200 kg of the starting material.

Development and Scale-Up of a Continuous Reaction for Production of an Active Pharmaceutical Ingredient Intermediate

Jonathan P. McMullen*

, Christopher H. Marton, Benjamin D. Sherry, Glenn Spencer, Joseph Kukura, and Natalie S. Eyke

Process Research and Development, Merck & Co., Inc., P.O. Box 2000, Rahway, New Jersey 07065, United States

Org. Process Res. Dev., Article ASAP

DOI: 10.1021/acs.oprd.8b00192

*E-mail: jonathan.mcmullen@merck.com.

Conclusions

A flow chemistry process for sustainable operations was developed by utilizing THF as a cosolvent to improve the solubility of the reagent degradants. Process robustness was further established by understanding the impact of mixing, residence time, and solvent composition on reaction performance. Identifying a suitable flow regime via the Reynolds number was identified as the scaling parameter for this flow reaction and used to scale the flow reaction from 20 mL/min in the lab to 1.6 L/min in the production environment. A modular flow reactor skid was fabricated for facile integration of flow chemistry components with existing batch equipment and was used to process 200 kg of starting material.

READ AT……….https://pubs.acs.org/doi/10.1021/acs.oprd.8b00192

///////////////Development, Scale-Up, Continuous Reaction, Production, Active Pharmaceutical Ingredient, Intermediate, flow chemistry, mixing sensitive reaction, scale-up

Scalable Flow Chemistry : A Flexible Tool for the Research, Developments and Production of Pharmaceuticals, Fine & Speciality Chemicals

FLOW CHEMISTRY, flow synthesis Comments Off

Oct 072016

Image result for chemtrix bv

Scalable Flow Chemistry : A Flexible Tool for the Research, Developments and Production of Pharmaceuticals, Fine & Speciality Chemicals
– Dr. Charlotte Wiles, Chief Executive Officer, Chemtrix BV, Netherlands

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A PRESENTATION

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Image result for chemtrix bv CHEMTRIX

///////Scalable Flow Chemistry, A Flexible Tool, Research, Developments, Production, Pharmaceuticals, Fine , Speciality Chemicals, Charlotte Wiles, Chief Executive Officer, Chemtrix BV, Netherlands

Optimization, Production, and Characterization of a CpG-Oligonucleotide-Ficoll Conjugate Nanoparticle Adjuvant for Enhanced Immunogenicity of Anthrax Protective Antigen

Uncategorized Comments Off

May 132016

We have synthesized and characterized a novel phosphorothioate CpG oligodeoxynucleotide (CpG ODN)-Ficoll conjugated nanoparticulate adjuvant, termed DV230-Ficoll. This adjuvant was constructed from an amine-functionalized-Ficoll, a heterobifunctional linker (succinimidyl-[(N-maleimidopropionamido)-hexaethylene glycol] ester) and the CpG-ODN DV230. Herein, we describe the evaluation of the purity and reactivity of linkers of different lengths for CpG-ODN-Ficoll conjugation, optimization of linker coupling, and conjugation of thiol-functionalized CpG to maleimide-functionalized Ficoll and process scale-up. Physicochemical characterization of independently produced lots of DV230-Ficoll reveal a bioconjugate with a particle size of approximately 50 nm and covalent attachment of more than 100 molecules of CpG per Ficoll. Solutions of purified DV230-Ficoll were stable for at least 12 months at frozen and refrigerated temperatures and stability was further enhanced in lyophilized form. Compared to nonconjugated monomeric DV230, the DV230-Ficoll conjugate demonstrated improved in vitro potency for induction of IFN-α from human peripheral blood mononuclear cells and induced higher titer neutralizing antibody responses against coadministered anthrax recombinant protective antigen in mice. The processes described here establish a reproducible and robust process for the synthesis of a novel, size-controlled, and stable CpG-ODN nanoparticle adjuvant suitable for manufacture and use in vaccines.

READ……http://pubs.acs.org/doi/full/10.1021/acs.bioconjchem.6b00107

Optimization, Production, and Characterization of a CpG-Oligonucleotide-Ficoll Conjugate Nanoparticle Adjuvant for Enhanced Immunogenicity of Anthrax Protective Antigen

Bob Milley^*^†, Radwan Kiwan^†, Gary S. Ott^†, Carlo Calacsan^†, Melissa Kachura^†, John D. Campbell^†, Holger Kanzler^‡, and Robert L. Coffman^†

^† Dynavax Technologies Corporation, 2929 Seventh Street, Suite 100, Berkeley, California 94710, United States

^‡ MedImmune LLC, One MedImmune Way, Gaithersburg, Maryland 20878, United States

Bioconjugate Chem., Article ASAP

DOI: 10.1021/acs.bioconjchem.6b00107

Publication Date (Web): April 13, 2016

*E-mail: bmilley@dynavax.com. Phone: (510) 665-7227. Fax: (510) 848-1327.

ACS Editors’ Choice – This is an open access article published under an ACS AuthorChoice License, which permits copying and redistribution of the article or any adaptations for non-commercial purposes.

//////Optimization, Production, Characterization, CpG-Oligonucleotide-Ficoll Conjugate Nanoparticle Adjuvant, Enhanced Immunogenicity, Anthrax Protective Antigen

EDQM adopts revised monograph for WFI allowing non-destillation techniques

regulatory Comments Off

Apr 012016

In a press release the EDQM has announced that the new monograph draft on Water for Injection (169) had been adopted. Read on to learn more about the production of WFI with membrane systems.

http://www.gmp-compliance.org/enews_05274_EDQM-adopts-revised-monograph-for-WFI-allowing-non-destillation-techniques_15254,15160,15090,15267,Z-PEM_n.html

In a press release, the European Pharmacopeia Commission has announced that the revised monograph on Water for Injection (WFI) had been adopted.

According to the revised monograph, it will be allowed in Europe in future to produce WFI with a purification method equivalent to distillation like e.g. reverse osmosis coupled with appropriate techniques. Moreover, the EDQM declares that a notice to the respective supervisory authorities will be required when a “non-distillation” technology is used for the production of WFI. Besides, the EDQM points out that it is not only a matter of equivalence of a specification but rather the robustness of the purification of WFI. Therefore, Annex 1, which is currently under revision, will also include requirements with regard to the production of WFI. The new Annex 1 will be available when the revised monograph becomes applicable.

With the modification of this monograph, harmonisation with the US Pharmacopeia and the Japanese Pharmacopeia goes one step further. In both countries, non-distillation technologies for the production of WFI are already allowed.

The revised monograph Water for Injections (169) will be published in Ph.Eur. Supplement 9.1 and apply as of April 2017. For further information please see the EDQM’s press release.