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.

Biomanufacturing Services Aseptic Fill/Finish and Lyophilization

Significant time and cost have been incurred to produce the bulk drug substance for your program. You are now searching for a partner you can trust to formulate, fill and finish into your desired final product container. Who can you trust with your valuable bulk material? Therapure is your trusted partner for cost-effective clinical and commercial scale fill/finish services.

Therapure has validated aseptic fill/finish suites for cost effective formulation, filling and finishing of clinical and commercial scale products. Therapure has experience filling and finishing both therapeutic proteins and small molecules into vials, preformed IV bags and prefilled syringes. Therapure also offers integrated lyophilization capabilities at both the clinical and commercial scale.

Our fill/finish suites and support systems were inspected and licensed by Health Canada in 2009. The fill/finish suites are scheduled to undergo multiple FDA pre-approval inspections in 2011.

Aseptic Fill/Finish Services :-

Container Type	Validated Equipment	Filling Capacity / Hour	Container Volumes (mL)
Vial Filling	Bosch TL	3,000 X 2 mL vials	2 - 200
Preformed IV Bag Filling	Plumat Bag Filler	800 bags	50 – 500
Prefilled Syringe	Cozzoli	1,200 x 2mL syringes	0.5-20

Lyophilization Services :-

Scale	Chamber Size	# Shelves	Temp Range	Batch to Vial Size Range
Clinical	1.1 m2 (12 ft2)	6 Shelves (114mm)	-70 to +650C	4,400 Units x 2mL 2,000 Units x 10mL
Commercial	7.5 m2 (81 ft2)	7 Shelves (100mm)	-70 to +800C	32,400 units x 2mL 17,100 units x 5mL 4,000 units x 50mL

Therapure will actively involve you in the implementation of your fill/finish project. Once the product is filled and finished, we perform 100% inspection of the drug product containers prior to labelling, and then finish with packaging and cartoning. We also offer storage and distribution services to your clinical or commercial sites. These services are designed for one goal; to be your one-stop for everything related to aseptic fill/finish & lyophilization.