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On-Site CDMO

The Discovery Labs has partnered with The Center for Breakthrough Medicines, an advanced therapies CDMO with unrivaled capacity in the Philadelphia Region.

Learn More about The Center for Breakthrough Medicines.

CDMO Overview

The Center for Breakthrough Medicines offers tenants of The Discovery Labs the capabilities and capacity necessary to improve both the speed and reliability of their testing and manufacturing processes.

Process Development labs supporting research, development, and scaled cGMP manufacturing of cell therapies, gene therapies, plasmids, and viral vectors.

Established technology transfer program for seamless laboratory transition of GMP manufacturing products for clinical phase trials and commercialization.

Scaled production of plasmids and viral vectors with on-site cell banking and cell processing.

Strategic industry partnerships with global suppliers ensuring an uninterrupted supply of materials, consumables, and equipment.

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CDMO Overview

The Center for Breakthrough Medicines offers tenants of The Discovery Labs the capabilities and capacity necessary to improve both the speed and reliability of their testing and manufacturing processes.

Process Development labs supporting research, development, and scaled cGMP manufacturing of cell therapies, gene therapies, plasmids, and viral vectors.

Established technology transfer program for seamless laboratory transition of GMP manufacturing products for clinical phase trials and commercialization.

Scaled production of plasmids and viral vectors with on-site cell banking and cell processing.

Strategic industry partnerships with global suppliers ensuring an uninterrupted supply of materials, consumables, and equipment.

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What Is A CDMO?

A contract development and manufacturing organization (CDMO) is an outsourcing laboratory for the pharmaceutical and life science industries specializing in the precise and delicate process of creating and bulk-producing life-changing and lifesaving drugs.

The Center for a Breakthrough Medicines is a cGMP cell and gene therapy CDMO specializing in CAR-T and viral vector preformulation, development, testing, clinical trials, and commercial production.

Learn More about The Center for Breakthrough Medicines.

 

What Is A CDMO?

A contract development and manufacturing organization (CDMO) is an outsourcing laboratory for the pharmaceutical and life science industries specializing in the precise and delicate process of creating and bulk-producing life-changing and lifesaving drugs.

The Center for a Breakthrough Medicines is a cGMP cell and gene therapy CDMO specializing in CAR-T and viral vector preformulation, development, testing, clinical trials, and commercial production.

Learn More about The Center for Breakthrough Medicines.

 

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cGMP and ISO Compliant CDMOs

The closer a drug or therapy gets to full-scale distribution, the more costly a production mishap becomes.  Mishandled or contaminated medicines can undo months or even years worth of research and development.  A CDMO must maintain strict cGMP and ISO compliance standards to ensure every medicine created, tested, and produced is safe for the end patient.

All machinery on-site is professionally installed, tested, calibrated, and balanced to be fully ISO certified, ensuring valid testing and safe manufacturing standards. All manual, partially-automated, or fully-automated manufacturing processes used are cGMP compliant.

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cGMP and ISO Compliant CDMOs

The closer a drug or therapy gets to full-scale distribution, the more costly a production mishap becomes.  Mishandled or contaminated medicines can undo months or even years worth of research and development.  A CDMO must maintain strict cGMP and ISO compliance standards to ensure every medicine created, tested, and produced is safe for the end patient.

All machinery on-site is professionally installed, tested, calibrated, and balanced to be fully ISO certified, ensuring valid testing and safe manufacturing standards. All manual, partially-automated, or fully-automated manufacturing processes used are cGMP compliant.

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CDMO Tech Transfer

Most clients move operations into a CDMO out of necessity.  A high-end CDMO must be prepared to adapt to and accommodate a client’s technical requirements to ensure all prior experimentations, cultures, and test samples are safely transferred.  

Every client will experience seamless tech transfer when moving their operations inside The Center for Breakthrough Medicines.  From proof of concept to product lifecycle management and everything in between, we have the technology and versatility to fully comply with any research organization’s tech transfer specifications and requirements.

CDMO Tech Transfer

Most clients move operations into a CDMO out of necessity.  A high-end CDMO must be prepared to adapt to and accommodate a client’s technical requirements to ensure all prior experimentations, cultures, and test samples are safely transferred.  

Every client will experience seamless tech transfer when moving their operations inside The Center for Breakthrough Medicines.  From proof of concept to product lifecycle management and everything in between, we have the technology and versatility to fully comply with any research organization’s tech transfer specifications and requirements.

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