Services

BEAM can help accelerate product pipelines of its corporate partners

Opportunity

To achieve leadership positions in areas of expertise with next generation ophthalmic materials and delivery systems, diagnostics, and cancer cell therapies.

Instrumentation

Access to instrumentation at McMaster and Fraunhofer including equipment for biological preparation, high-throughput screening, bioselectivity, and surface characterization along with associated operational expertise to characterize test components and optimize assays.

Project Management

Professional project management based on the vast experience of McMaster and Fraunhofer with industrial joint development projects to ensure key timelines are met and milestones are achieved.

In-house Support

Expertise in support of quality and regulatory requirements.

Intellectual Property

Access to existing McMaster’s and Fraunhofer’s intellectual property and assistance with securing new patents via McMaster’s office of intellectual property (MILO).

Facility

Access to 16,000 sq ft of laboratory space for mammalian and bacterial cell culture, synthesis of biomaterials and bioanalysis as well as 4000 sq ft of mixed use office space and meeting rooms.

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Suites

Infrastructure at BEAM housed in a 20,000 sq. ft. centre and is organized into 4 different instrument suites

Mammalian Cell Culture

Consists of infrastructure for preparation of biological materials (cells, proteins, nucleic acids including aptamers), both at biosafety level 1 and biosafety level 2. The infrastructure is designed to allow for medium-throughput preparation of biological species in mg to gram quantities. Infrastructure for both bacterial and mammalian cells will include tools for cell culture (autoclave, biosafety cabinets, microscopes, incubators); protein preparation (homogenizers, centrifuges, chromatography); and DNA (PCR, electrophoresis).

Chemical and Materials Synthesis

Infrastructure for the synthesis, purification and characterization of organic, inorganic, nanoparticle-based and composite biomaterials systems. Researchers will have access to fume hoods; vacuum lines (for air sensitive reactions); robotic synthesis systems; automated weighing and dilution; printing systems; solvent purification; liquid chromatography and mass spectrometry.

Bioanalytical

Houses the infrastructure necessary for the physical and chemical characterization of small molecules, surfaces (bead and planar), and a range of instruments for detailed analysis of the activity/selectivity of species generated at BEAM. Among the analytical instrumentation in the suite will include plate readers; mass spectrometers (including an Illumina MiSeq system for nucleic acid sequencing); and microarray readers.

Prototyping

Contains infrastucture for the medium scale production and characterization of diagnostic prototypes developed at BEAM in conjunction with industrial partners. Equipment will include large-scale printers; humidity and temperature controlled storage rooms; assembly areas; and manufacturing lines.

Focal Areas

Diagnostics

The Diagnostics unit of the Fraunhofer Project Centre BEAM focuses on the development of printable next generation diagnostic tests applicable to point-of- care settings. FPC-BEAM has the expertise and infrastructure to create scalable prototype assays for validation and clinical evaluation. Aptamer and antibody-based reagents in conjunction with on device amplification and reporting results in single-step biomedical diagnostics with superior sensitivity and specificity.

Core areas of expertise within the Diagnostics Unit in FPC-BEAM include: 1) Optimization of Sensor Surfaces; 2) Development of new printable components for POC sensors; 3) Generation of application-specific DNA-based sensors, and; 4) Integration and scale-up of ISO compliant POC sensors. We develop tests using markers identified by our industry or clinical partners, or those identified from the Biomarker unit of the Fraunhofer Project Centre BEAM. The technologies available at FPC-BEAM are broadly applicable in the point-of- care setting. Aptamer based technologies can be applied to proteins, nucleic acids, as well as non-immunogenic targets such as small molecules. Ongoing projects are focused on infectious disease diagnostics, clinical chemistry tests, and neonatal screening in resource poor settings.

The facility is ISO 13485: 2016 compliant and works with partners to ensure design controls are in place to meet regulatory requirements. FPC BEAM can also assist partners with clinical study requirements and regulatory support thus providing support for all of your pre-commercial requirements.

Biomarkers

At the Biomarker unit of the Fraunhofer Project Centre BEAM which collaborates with the RIBOLUTION Biomarker Centre at the Fraunhofer Institute of Immunology and Cell Therapy in Leipzig, novel biomarkers are identified based on ribonucleic acids and developed through to clinical “proof of concept” with the aid of selected patient cohorts.

At present, activities are primarily focused on development programs in the areas of prostate cancer, chronic obstructive pulmonary disease and infectious diseases. By integrating state-of-the-art genomic analysis methods such as next-generation sequencing using bioinformatical data analysis methods developed in house, the Biomarker unit of the Fraunhofer Project Centre BEAM is able to identify biomarkers and develop new diagnostic tests at the highest technological level.

The highest quality standards are defined and implemented from start to finish, which increases the intrinsic value of the obtained data and lays the foundations for the implementation of a quality management system pursuant to DIN ISO 13485, which will become necessary as projects progress towards commercialization.

Cell Therapies

The Cell Therapy unit at the Fraunhofer FPC-BEAM focuses its research and development activities on the establishment of novel targeted therapies for different cancer indications using chimeric antigen receptor transduced, autologous immune cells.

In addition, the FPC-BEAM offers comprehensive expertise for automation of the manufacturing process of these cells providing innovative microfluidic technology, biosensors, process control and other techniques to significantly drop the cost of cell-based therapies, thereby facilitating their adoption on the global market.

Through its connection with the Engineering department of McMaster University, the FPC-BEAM can also offer tailored, scalable solutions for the manual production of autologous cell therapies that offer a significant opportunity for contract manufacturers to their needs within the field of automated cell manufacturing.

Biomaterials

The Biomaterials unit of the Fraunhofer Project Centre BEAM focuses on the development of biomaterial for ocular applications, including new drug delivery platforms, better more comfortable contact lens materials and surfaces and new intraocular lens materials with lower complication rates. FPC-BEAM has the expertise and infrastructure to create new materials and surfaces for validation and can perform full preclinical validation, with a goal of partnering for clinical evaluation.

The Biomaterials Unit in FPC-BEAM develops materials and delivery systems based on the needs identified by our industry or clinical partners. The technologies under development at FPC-BEAM, while designed for ocular applications, may be useful in other tissues. The novel polymers are based on clinically acceptable materials, previously approved for use in human patients; the methods of delivery have also shown clinical acceptability. Ongoing projects are focused on mucoadhesive nanomaterials for increasing the residence time at the front of the eye and injectable polymeric systems for delivery of drugs to the posterior eye as well as novel monomers and surfaces in contact lens and intraocular lens applications.

The facility is ISO 13485: 2016 compliant and works with partners to ensure design controls are in place to meet regulatory requirements. FPC BEAM can also assist partners with preclinical study requirements and regulatory support thus providing support for all of your pre-commercial requirements.