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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 protein­based products with  clients’ product specific knowledge to create a cost­effective 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 in­process   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, HEK­293, 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  pre­filled  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 pre­filled 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 pre­inspections. 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,   walk­in   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. By :­ Therapure Biopharma Inc


Biomanufacturing Services