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Nuevos métodos de caracterización para control de calidad en la producción de proteínas

Resumen

Tipo:
Demanda Tecnológica
Referencia:
TRUK20150505001
Publicado:
01/06/2015
Caducidad:
23/11/2015
Resumen:
Una sucursal británica de una multinacional industrial dedicada a la producción de proteínas terapéuticas busca nuevas técnicas aplicables a controles de calidad. Las técnicas buscadas deben permitir la reducción del número de ensayos o el desarrollo de métodos de múltiples atributos (MAMS) que evalúen simultáneamente diferentes características de las proteínas. También deben demostrar un nivel de seguridad comparable a los métodos actuales. Se buscan socios académicos y empresas con el fin de establecer acuerdos de cooperación técnica, licencia o joint venture.

Details

Tittle:
Novel characterisation methods for quality control in protein production
Summary:
The UK branch of an international industrial producer of therapeutic proteins is seeking novel techniques applicable to quality controls. These should be amenable to automation and streamlining whilst retaining assurance compared to existing standards.
Academia and businesses are sought for technical cooperation, licensing or joint ventures.
Description:
The UK branch of an international industrial producer of therapeutic proteins is seeking novel techniques applicable to quality controls.
During manufacturing, they detect and measure multiple Critical Quality Attributes (CQAs) of therapeutic proteins. It is important to ensure the safety and efficacy of the produced therapeutic proteins through evaluation of key physical, chemical, biological and microbiological characteristics. The CQAs are monitored in both upstream and downstream process activities. Upstream processes focus on producing the molecule of interest while downstream processes target purification while maintaining product integrity and activity. CQAs therefore should be within appropriate limits to ensure the desired product quality and performance for release.

There are several common and routinely used technologies and methods for analysing CQAs (e.g. MS, HPLC, electrophoresis, SPR, immunoassays, NMR, qPCR etc.), however these tests are usually done in isolation and/or sequentially and often focus on single attributes. This limits the throughput and in-line/on-line capabilities as well as restricting automation of the process.

The company is keen to identify a single analytical technique, or a fully integrated platform consisting of more than one analytical technique that can be used without analyst intervention.

The techniques and methods should enable the reduction in the number of assays, or the development of multi-attribute methods (MAMs) which can evaluate several critical protein characteristics simultaneously.
At the same time they need to demonstrate a level of assurance comparable to current methods.

Below, under Technical Specification are some but not all of the CQAs the company is interested in measuring, listed in order of priority for Upstream and Downstream processes. CQAs for the Upstream process are of the highest priority, followed by Downstream and then Release.

In the case of deploying MAMs for in-line monitoring and upstream process development, high throughput, automated technology platforms are highly desired. As the products are currently manufactured in bioreactors, solutions that can work in-situ, that don't require sample preparation and that can work with limited purity and concentrations are of special interest. Chemometric type techniques that can 'fingerprint' a product and relate that to quality are also of interest.

The company is open to all reasonable collaboration agreements including licensing, joint ventures and technical cooperation.

Additional information can be provided on request. Interested parties are invited to send a brief non-confidential description of their solutions and proposed deployment routes.
Technical Specification or Expertise Sought:
Upstream process (Cell culture): Titre/Concentration; Potency/Binding; Glycan profile; Charge profile; Media components (mammalian cells); Aggregation; Host cell protein (HCP).

Downstream process (purification steps): Purity (Aggregation, fragmentation , Host cell protein); Endotoxin; Titre/concentration; Post translational modification and primary sequence; Potency/Binding; Charge profile.

Release: Residual DNA; Residual protein A; Sub visible particles; Excipients; Free Sulfhydryls; pH.

Partner sought

Type and Role of Partner Sought:
- Type of partner sought: industry and academia.
- Specific area of activity of the partner: materials and methods for characterising proteins.
- Task to be performed by the partner sought: the type of collaboration may vary dependent on the stage of development, including technical cooperation, licensing or joint ventures.

Client

Type and Size of Client:
Industry >500 MNE
Already Engaged in Trans-National Cooperation:
Si
Languages Spoken:
English