Entrepreneurship and Regional Development: State of the Art

2019 ◽  
Vol 5 (2) ◽  
pp. 58-66
Author(s):  
Luísa Carvalho
Keyword(s):  
Regional Development ◽  
State Of The Art ◽  
Therapeutic Protein ◽  
Subvisible Particles ◽  
Protein Formulations ◽  
Parenteral Formulations ◽  
Development State ◽  
Formulation Stability

The presence of subvisible particles (SVPs) in parenteral formulations of biologics is a major challenge in the development of therapeutic protein formulations. Distinction between proteinaceous and non-proteinaceous SVPs is vital in monitoring formulation stability.

Separation, Characterization and Discriminant Analysis of Subvisible Particles in Biologics Formulations

2019 ◽  
Vol 20 (3) ◽  
pp. 232-244 ◽  
Author(s):  
Zahir S. Akhunzada ◽  
Mario Hubert ◽  
Erinc Sahin ◽  
James Pratt
Keyword(s):  
Morphological Filter ◽  
Subvisible Particles ◽  
Light Obscuration ◽  
Protein Formulations ◽  
Limited Success ◽  
Intensity Parameters ◽  
Mixed Aggregates ◽  
Parenteral Formulations ◽  
Formulation Stability ◽  
Low Refractive Index

Background:The presence of subvisible particles (SVPs) in parenteral formulations of biologics is a major challenge in the development of therapeutic protein formulations. Distinction between proteinaceous and non-proteinaceous SVPs is vital in monitoring formulation stability.Methods:The current compendial method based on light obscuration (LO) has limitations in the analysis of translucent/low refractive index particles. A number of attempts have been made to develop an unambiguous method to characterize SVPs, albeit with limited success.Results:Herein, we describe a robust method that characterizes and distinguishes both potentially proteinaceous and non-proteinaceous SVPs in protein formulations using Microflow imaging (MFI) in conjunction with the MVAS software (MFI View Analysis Suite), developed by ProteinSimple. The method utilizes two Intensity parameters and a morphological filter that successfully distinguishes proteinaceous SVPs from non-proteinaceous SVPs and mixed aggregates.Conclusion:he MFI generated raw data of a protein sample is processed through Lumetics LINK software that applies an in-house developed filter to separate proteinaceous from the rest of the particulates.

The Use of Flow Cytometry for the Detection of Subvisible Particles in Therapeutic Protein Formulations

2011 ◽  
Vol 100 (5) ◽  
pp. 1671-1678 ◽  
Author(s):  
Henryk Mach ◽  
Akhilesh Bhambhani ◽  
Brian K. Meyer ◽  
Steven Burek ◽  
Harrison Davis ◽  
...  
Keyword(s):  
Flow Cytometry ◽  
Therapeutic Protein ◽  
Subvisible Particles ◽  
Protein Formulations

scholarly journals Overlooking Subvisible Particles in Therapeutic Protein Products: Gaps That May Compromise Product Quality

2009 ◽  
Vol 98 (4) ◽  
pp. 1201-1205 ◽  
Author(s):  
John F. Carpenter ◽  
Theodore W. Randolph ◽  
Wim Jiskoot ◽  
Daan J.A. Crommelin ◽  
C. Russell Middaugh ◽  
...  
Keyword(s):  
Product Quality ◽  
Therapeutic Protein ◽  
Subvisible Particles

scholarly journals DIAGNÓSTICO DO SETOR ERVATEIRO NA 26a SECRETARIA DE DESENVOLVIMENTO REGIONAL (SDR) DO ESTADO DE SANTA CATARINA

FLORESTA ◽  
2010 ◽  
Vol 40 (3) ◽  
Author(s):  
Juliano Gil Nunes Wendt ◽  
Flaviana Friedrich
Keyword(s):  
Regional Development ◽  
The State ◽  
Southern Brazil ◽  
Santa Catarina ◽  
Development State

O presente estudo teve como objetivo a verificação da realidade do setor ervateiro na 26ª Secretaria de Desenvolvimento Regional – SDR do estado de Santa Catarina. Compreendem esta secretaria os seguinte municípios: Bela Vista do Toldo, Canoinhas, Irineopólis, Major Vieira, Porto União e Três Barras. O trabalho aborda questões relativas aos produtos, a produção e as angustias e anseios dos produtores de uma das mais antigas atividades de extração vegetal da Região Sul do Brasil. Foram aplicadas entrevistas por meio de questionários com perguntas semi estruturadas, foi usada a metodologia de bola de neve, ou seja, o entrevistado ao final das respostas do questionário deveria indicar outro possível candidato para ser entrevistado. O período da pesquisa foi de agosto/2008 a maio/2009. Neste contexto é fundamental e imprescindível uma organização do setor produtivo de erva-mate, nos mais diversos aspectos, sejam eles, sociais, tecnológicos, silviculturais ou comerciais.Palavras-chave: Diagnóstico; erva-mate; setor produtivo. AbstractThe matte sector diagnosis in the 26th Secretary of the Regional Development, State of Santa Catarina, Brazil. This study aimed to study the reality of the matte sector in the 26th Secretary of Regional Development (SDR) of the State of Santa Catarina, which includes the following Counties: Bela Vista do Toldo, Canoinhas, Irineópolis, Major Vieira, Porto União and Três Barras. The work included issues relating to products, production, distress and desires of the producers about one of the oldest vegetal extraction activities in southern Brazil. Interviews were carried out by means of semi structured questionnaires. The methodology used was the “snowball”, i.e., at the end of the interview the person who filled out the questionnaire indicated another possible candidate to be interviewed. The period of search was August/2008 to May/2009. In this context, it is essential the organization of the matte productive sector in social, technological, and commercial aspects.Keywords: Diagnosis; mate; the productive sector.

scholarly journals Nanotechnology as a Platform for the Development of Injectable Parenteral Formulations: A Comprehensive Review of the Know-Hows and State of the Art

Pharmaceutics ◽  
2020 ◽  
Vol 12 (6) ◽  
pp. 510 ◽  
Author(s):  
Maryam Shetab Boushehri ◽  
Dirk Dietrich ◽  
Alf Lamprecht
Keyword(s):  
Significant Contribution ◽  
State Of The Art ◽  
Pharmaceutical Sciences ◽  
Drug Solubility ◽  
Comprehensive Review ◽  
Fields Of Study ◽  
Recent Developments ◽  
Parenteral Formulations ◽  
Long Acting ◽  
External Stimuli

Within recent decades, the development of nanotechnology has made a significant contribution to the progress of various fields of study, including the domains of medical and pharmaceutical sciences. A substantially transformed arena within the context of the latter is the development and production of various injectable parenteral formulations. Indeed, recent decades have witnessed a rapid growth of the marketed and pipeline nanotechnology-based injectable products, which is a testimony to the remarkability of the aforementioned contribution. Adjunct to the ability of nanomaterials to deliver the incorporated payloads to many different targets of interest, nanotechnology has substantially assisted to the development of many further facets of the art. Such contributions include the enhancement of the drug solubility, development of long-acting locally and systemically injectable formulations, tuning the onset of the drug’s release through the endowment of sensitivity to various internal or external stimuli, as well as adjuvancy and immune activation, which is a desirable component for injectable vaccines and immunotherapeutic formulations. The current work seeks to provide a comprehensive review of all the abovementioned contributions, along with the most recent advances made within each domain. Furthermore, recent developments within the domains of passive and active targeting will be briefly debated.

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