Therapure Biopharma Development, Scale Up and Manufacture of Complex Biologics

Therapure Biopharma is a contract development and manufacturing organization (CDMO) that specializes in the development, scale up and manufacture of complex biologics. Therapure operates a modern 130,000ft² cGMP facility in the Greater Toronto area that is equipped with Class A to C clean rooms, QC and analytical labs, clinical and commercial-scale manufacturing suites, mammalian cell culture production capability with upstream and downstream processing, and aseptic fill/finish capacity.

Biologics contract manufacturing

As a specialist in biologics contract manufacturing, Therapure understands your process scale up and cGMP manufacturing needs. We work as an extension of your organization, adding value as your trusted biologics manufacturing partner. Therapure has over 20 years of experience manufacturing a variety of sources of API, including:

• Whole blood and plasma
• Mammalian cell culture
• Primary cell culture

Protein manufacturing services

Therapure is highly experienced in protein scale up and cGMP manufacturing. When batch manufacturing starts, we encourage clients to be on-site, observing the manufacturing runs with us. Upon completion, we review the run with the client, going through every technical aspect of the batch records in order to fine tune the process for the next run.

Our protein manufacturing capabilities include:

• Upstream: mammalian cell culture processes (CHO, HEK-293, Hybridoma, etc.); master cell bank (MCB) creation; seed train from 5l to 500l single use bioreactors (SUBs); media preparation up to 6,000l batches
• Midstream: harvest by nominal flow filtration, tangential flow filtration or centrifugation; viral inactivation tanks (pH, solvent-detergent, temperature); nanofiltration
• Downstream: dedicated ‘non-live’ processing area; chromatographic volumetric rates from 10ml/min to 10l/min; ultrafiltration / diafiltration up to 100m² of membrane; protein modification (conjugation, refolding, enzymatic conversion, etc.); buffer preparation up to 6,000l batches; bulk filling

Glass vial filling

When you are searching for a company to formulate, fill and finish your bulk drug substance into your desired final product container, Therapure is your trusted partner for cost-effective clinical and commercial-scale fill/finish services. Therapure has experience filling and finishing both therapeutic proteins and small molecules into glass vials, preformed IV bags and prefilled syringes.

For glass vial filling Therapure uses Bosch TL equipment and can fill 3,000 x 2ml vials per hour. Container volumes can range from 2ml to 200ml.

Lyophilization services

Therapure offers integrated lyophilization capabilities at both the clinical and commercial scale.

Clinical-scale lyophilization:

• Chamber size: 1.1m² (12ft²)
• Number of shelves: six shelves (114mm)
• Temperature range: -70°C to +65°C
• Batch to vial size: 4,300 units x 2ml; 2,000 units x 10ml

Commercial-scale lyophilization:

• Chamber size: 7.5m² (81ft²)
• Number of shelves: seven shelves (100mm)
• Temperature range: -70°C to +80°C
• Batch to vial size: 35,000 units x 2ml; 16,000 units x 5ml; 3,700 units x 50ml

cGMP contract manufacturing services for biologics

Therapure operates a world-class 130,000ft² facility with over 28,000ft² of cGMP manufacturing space. Our cGMP contract manufacturing services are designed to help you every step of the way – from technology transfer and process development, to analytical development and testing, to the scale up and cGMP manufacturing phases and then on to aseptic fill/finish and lyophilization and, finally, a range of support services, including GMP-compliant warehousing, distribution services, validation support, and stability testing services.