Therapure Biopharma

Development, Scale Up and Manufacture of Complex Biologics

2585 Meadowpine Boulevard, Mississauga, Ontario, L5N 8H9, Canada



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.

Scale Up and cGMP Manufacturing

You have taken your drug candidate as far as you can. It is time to scale up your process from the bench to clinical or commercial size batches. But is your process robust enough?

Sanofi – Lonza Biologics Production Facility, Visp

Leading Switzerland-based biopharmaceuticals supplier Lonza and French life sciences firm Sanofi has established a joint venture (JV) to set up a large-scale biologics production facility in Visp, Switzerland.

Baxalta Biologics Facility, Georgia

Baxter's biopharmaceutical spin-off company, Baxalta began construction of a new biologics facility in August 2012. It selected a site for the proposed facility in the city of Covington.

Therapure Biopharma Awarded US Government Contract for Development of Anti-Nerve Gas Agent

Therapure Biopharma, a contract development and manufacturing organization (CDMO) of biotherapeutics, is pleased to announce that the company will participate as a subcontractor for DynPort Vaccine Company (DVC), a CSC company, that was awarded a US cost-plus-fixed-fee contract with a maximum value of $157.3m (prime contract number W911QY-13-C-0056) by the US Department of Defense (DoD) to support the development of a prophylactic countermeasure to prevent the effects of organophosphorus nerve agent poisoning.

Therapure Biopharma Wins a 2013 CMO Leadership Award

Therapure Biopharma has announced today that its biomanufacturing division, Therapure Biomanufacturing, has won the 2013 CMO Leadership Award as a leader in all five categories: Quality, Reliability, Innovation, Productivity and Regulatory.

Therapure Biopharma, Inc.

2585 Meadowpine Boulevard

Mississauga

Ontario

L5N 8H9

Canada

+1 905 286 6200 +1 905 286 6300 www.therapurebio.com Therapure on YouTube