Therapure's Biotech Manufacturing targets Clients' Scale Up & cGMP Manufacturing needs

Therapure Biopharma is a Contract Development and Manufacturing Organization (CDMO) that specializes in the development, scale up and manufacture of protein therapeutics and protein purification. Therapure operates a modern 130,000 ft2 cGMP facility 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. This facility coupled with the skilled staff provides clients with a complete range of integrated biomanufacturing services.

Technology Transfer & Process Development :-

The technology transfer program combines Therapure's significant experience developing protein-based products with clients’ product specific knowledge to create a cost-effective and efficient development program. Therapure’s process development services include: vector design and construction, host cell line optimization, cell banking, upstream & downstream processing and buffer formulation development.

Analytical Development & Testing :-

Therapure can support client needs with robust and reliable analytical methods that are used to support in-process analysis, bulk and drug product release testing and stability monitoring programs. Therapure has expertise in developing product specific assays and in the development, qualification and validation of cGMP compliant analytical methods including complex biological activity assays.

Scale Up & cGMP Manufacturing :-

With 28,000 ft2 of cGMP manufacturing space including pilot, clinical and commercial scale production capacity Therapure is able to meet their client’s scale up needs. Therapure has >20 years of experience manufacturing a variety of sources of API covering mammalian cell culture, whole blood and plasma and primary cell culture. Upstream capabilities include: CHO, HEK-293, hybridoma and stem cell culture, master cell bank creation and media preparation. Downstream expertise includes, protein purification, protein modification and large scale buffer preparation. Therapure is a recognized global leader in their expertise in the production and purification of whole blood and plasma products.

Aseptic Fill/Finish & Lyophilization :-

Therapure is the only Canadian company that offers aseptic fill/finish of glass vials, preformed IV infusion bags and pre-filled syringes at both clinical and commercial scale. Therapure has Health Canada- licensed aseptic fill/finish suites for glass vials and validated fill/finish suites for IV infusion bags and pre-filled syringes. A Mutual Recognition Agreement (MRA) between Canada and the EU allows for selected aseptic fill/finished glass vials produced at Therapure to be sold directly into Europe without receiving country pre-inspections. Lyophilization development and optimization services are available along with clinical and commercial scale lyophilization capacity.

Support Services :-

Therapure’s support services were designed to provide a complete biomanufacturing service offering, thereby minimizing logistics and providing one point of contact. Warehousing and material handling are provided with 24/7 access control and monitoring in a range of environments including freezers, walk-in cold rooms, incubators and explosion rated rooms. Therapure's validated shipping protocols allow them to provide next day delivery in North America and Europe. Therapure also offers validation support and stability testing compliant with ICH guidelines.

Therapure's diverse group of clients continues to value the quality systems and broad range of biomanufacturing services that Therapure provides. The integrated service offering allows clients to remain with Therapure throughout the development and commercialization stages of production.

Aseptic Fill Finish and Lyophilization

Therapure BioPharma is a therapeutic protein-specialized Contract Development and Manufacturing Organization (CDMO) that offers a range of biomanufacturing services including technology transfer & process development, analytical development & testing, scale-up & cGMP manufacturing, aseptic fill/finish, lyophilization and support services.

Therapure is the only Canadian company that offers aseptic fill/finish of glass vials, preformed IV infusion bags and pre-filled syringes at both clinical and commercial scale. Therapure has significant experience, capabilities and capacity for the fill/finish and lyophilization of therapeutic proteins. Within their 130,000 ft2 cGMP facility Therapure has Health Canada- licensed aseptic fill/finish suites for glass vials and validated fill/finish suites for IV infusion bags and pre-filled syringes.

A Mutual Recognition Agreement (MRA) between Health Canada and the EU allows for selected aseptic fill/finished glass vials produced at Therapure to be sold directly into Europe without receiving county pre-inspections. This shortens time to market and allows for lower inventory requirements for Therapure’s European clients.

Therapure offers fill/finish services for their client’s bulk drug substance either produced off-site or as an add-on to Therapure’s own cGMP manufacturing services. Therapure is an ideal partner for biotech companies as they can provide this integrated service from manufacturing to fill/finish to storage and distribution of finished product. Therapure provides lyophilization cycle development and optimization services and in 2010 added commercial lyophilization capacity to its clinical scale lyophilization capabilities allowing production batches in the tens of thousands.

Therapure Biopharma, a proteins development company inspects 100% of the drug product containers prior to final labelling and packaging so as to meet their rigorous quality control standards. Therapure provides warehousing and material handling in their cGMP compliant warehouse for finished goods with next day delivery to clinical and commercial sites throughout North America and Europe.

Therapure’s customer focused flexibility, scientific expertise and scalable capacity allows Therapure to adapt to meet the fill/finish and lyophilization needs of its clients at every stage of the development and commercialization process.

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? Will it stand up to a 5, 10, 50 or 100 times scale up? Who can you turn to for protein and antibody scale up and cGMP manufacturing experience? Therapure is your trusted partner who can meet your process scale up and cGMP manufacturing needs.


Therapure Biopharma operates a 130,000 ft2 world-class facility with over 28,000 ft2 of cGMP manufacturing space. Operating a range of classified suites from Grade A (Class 100:ISO 5) through Grade C (Class 100,000:ISO 8), Therapure maintains utilities compliant to USP and EP including Water for Injection, Purified Water, Clean Steam and Oil-Free Compressed Air.

During process scale up, Therapure keeps its clients engaged in the project, actively soliciting decisions on raw materials, components, consumables, process specific Standard Operating Procedures (SOPs), Batch Production Records, Analytical Test Methods, Product Specifications and Process Flow Diagrams. We work as an extension of your organization, adding value as your trusted manufacturing partner. When batch manufacturing starts, we encourage clients to be onsite, 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.

Therapure has experience utilizing a variety of different sources of API including :-

• Whole Blood and Plasma
• Mammalian Cell Culture
• Primary Cell Culture

Highlights of our manufacturing capabilities and capacities:-

• Tissue Processing :-

Dedicated Grade C (Class 100,000:ISO 8) suites through configurable HVAC systems

• Protein Manufacturing :-

1. Upstream :-

• Mammalian cell culture processes (CHO, HEK-293, Hybridoma, etc.)
• Microbial processes (through strategic partnerships)
• Master Cell Bank (MCB) creation
• Seed train from 5L to 500L Single Use Bioreactors (SUBs)
• Media preparation up to 6,000L batches

      2.   Midstream :-

• Harvest by nominal flow filtration, tangential flow filtration or centrifugation
• Viral inactivation tanks (pH, solvent-detergent, temperature)
• Nanofiltration

      3.  Downstream :-

• Dedicated 'non-live' processing area
• Chromatographic volumetric rates from 10mL/min to 10L/min
• Ultrafiltration / diafiltration up to 100 m2 of membrane
• Protein modification (conjugation, refolding, enzymatic conversion, etc.)
• Buffer preparation up to 6,000L batches
• Bulk filling

New Venture by Therapure Biopharma for a Human Cause

cell line development and protein production services

Therapure Biopharma is a privately held integrated Contract Development and Manufacturing Organization (CDMO) that was founded in the third quarter of 2008 on the significant experience and manufacturing assets of a successful Canadian biotech company. Since 2008, Therapure has expanded its capabilities and completed a series of facility upgrades that have allowed it to offer an impressive range of integrated biomanufacturing services to its clients.

Therapure provides completely scalable cGMP manufacturing with mg to kg capacity. This allows biotech companies to remain partners with them as their therapeutic protein moves through pre-clinical, clinical and finally to commercial production. Therapure has a track record of working closely with companies of all sizes, from small biotech to large multinationals. Their experience is particularly valuable to biotech companies in solving the technical challenges that they will encounter in the manufacture and fill/finish of complex biologic products. Therapure's integrated services include: technology transfer & process development, analytical development & testing, scale up & cGMP manufacturing, aseptic fill/finish & lyophilization and support services.

Client engagement is important to Therapure to ensure that they are meeting all of their client's CDMO needs. This is accomplished through a collaborative environment that includes joint technical project teams, soliciting input on key processes and finally onsite observation and review of initial production runs.

Throughout 2010 Therapure has signed a series of biomanufacturing and fill/finish contracts and partnerships with international companies helping to build on their positive reputation in the global CDMO industry.

Key accomplishments of 2010 include :-

• Partnership with Microbix for manufacturing Water For Injection products
  
  
• Fill/Finish contract for pre-filled syringes of Stellar Pharmaceutical’s Neovisc® natural viscosupplement
  
  
• Launch of commercial scale lyophilization services
  
  
• Biomanufacturing agreement with LFB Biomedicaments for two key plasma proteins
  
  
• Fill/Finish contract with Kane Biotech for their proprietary development-stage product
  
  
• Fill/Finish contract with Viron Therapeutics for on-going clinical trials
  
  
• Biomanufacturing contract with ProChon Biotech for their clinical stage therapeutic product
  
  
• Biomanufacturing contract with Diamedica to provide cell line development and protein production services for a diabetes and neurological disorders product
  
  
• Fill/Finish contract with OPK Biotech for the development of an oxygen transport therapeutic product
  
  
• Founding partner of the International Malaria Research Consortium
  
  

As a leading Pharmaceutical Contract Manufacturers, Therapure is dedicated to reduce the time, cost, technical and compliance risks of getting their partner's therapeutic protein to market.