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.

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.