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Passion for Your Process, Product, and Patients

Dina Iezzi

August 1, 2013

2 Min Read

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Contract manufacturing of biologics is more than having superior technology — it’s having experienced people who are passionate, responsive, and committed to developing and manufacturing your biotherapeutics to improve patient care. As a fully integrated contract development and manufacturing organization (CDMO), Therapure Biomanufacturing has the scientific and technical expertise to successfully deliver at every stage of product development (preclinical, clinical, and commercial). Our 130,000-ft2 (12,000-m2) CGMP manufacturing facility meets FDA, EMA, and HPFB regulatory standards and includes flexible clinical and commercial production suites.

Development Services

Therapure appreciates the complexity of the development process. Our range of services is supported by a deep scientific understanding of process and analytical development. Our development services include

Cell Line: generation of well-characterized, stable mammalian cell lines

Upstream: development of scalable cell culture processes

Downstream: development of reproducible, scalable, and cost-effective processes for purification of proteins from a number of biological sources including plasma, transgenic sources, and mammalian cell culture

Analytical Methods: bioanalytical assay development and characterization throughout the product development stages.

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CGMP Manufacturing

We recognize that a strategic partnership with you is required to achieve complex current good manufacturing practice (CGMP) manufacturing solutions. We meet your clinical and commercial CGMP manufacturing needs through superior technology and scientific expertise. Our CGMP manufacturing services include

Upstream Processing: mammalian cell culture capacities from 50 L to 2,500 L

Downstream Processing: purification techniques including chromatography, fractional precipitation, pasteurization, and virus removal/inactivation

QC Analytical Testing: CGMP analytical laboratories that provide comprehensive analytical testing in support of development and manufacturing.

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Aseptic Fill/Finish

A key aspect of biotherapeutic manufacturing is the delivery of a sterile product to the patient. Therapure’s state-of-the-art facility supports aseptic fill of your biologic products from preclinical stages through clinical trials to commercial manufacturing. Our aseptic fill/finish services include

  • Vials

  • Prefilled syringes

  • Preformed IV bags

  • Lyophilization.

Support Services

Therapure uses a broad range of technologies to support the development and manufacture of your biotherapeutics, which minimize logistics and reduce risk. Some of our support services include

  • Validation support

  • Stability testing

  • Regulatory (preparation of CMC-supporting documentation)

  • Warehousing and material handling

  • Distribution.

We invite you to feel the difference at Therapure Biomanufacturing, where the client experience is our passion and patient care is our commitment.

About the Author

Author Details
Dina Iezzi is director of marketing and special projects at Therapure Biopharma, Inc., 2585 Meadowpine Boulevard, Mississauga, ON, Canada L5N 8H9; 1-905-286-6270; [email protected]; www.therapurebio.com.