Bioanalytical Development And Testing

Therapure operates under the principle, ‘Start with us, stay with us,’ meaning that we provide a range of services to our clients minimizing logistics and creating one point of contact.

 

Supporting every successful drug development program are reliable and robust analytical methods. These methods must be designed to support in-process analysis, bulk release testing, drug product release testing and stability monitoring programs. Who can provide the required support for your method development, qualification and validation needs? Therapure is your trusted partner for developing and validating analytical methods.

Therapure understands the importance of your critical methods and how they support your unique program.

Our facility has 10,600 ft2 of fully equipped analytical development and quality control testing space. Our Bioanalytical Development and quality control teams have extensive experience in the development, qualification, and validation of cGMP compliant analytical methods, including complex biological activity assays. Immediately following project kick-off, our analytical development team begins transferring your established assays or developing products specific assays from scratch. Prior to product manufacturing, the analytical methods are transferred to Therapure’s Quality Control department where they are qualified (for Phase I-II Clinical programs) or validated (for Phase III/Commercial programs) through mutually approved protocols.

Our experience in method development, optimization, qualification and validation includes:-

• Physiochemical analysis
• Raw material methods (custom or compendial)
• Compendial methods (USP, Ph. EU, JP, NF)

Protein concentration (UV-Vis, fluorescence)

• Spectrophotometry
• Nephelometry
• Colorimetric

Gel electrophoresis

• SDS-PAGE
• IEF
• 2-Dimensional

Flow cytometry

ELISA

Cell based bioassays

High performance liquid chromatography

• Standard (SEC, RP, Ion Exchange)
• Specialized

Total organic carbon

Gas chromatography (headspace & liquid)

Microbiological testing

• Microbial identification
• Endotoxin analysis (gel clot)
• Particulate matter
• Sterility
• Bioburden

Protein characterization

• Amino acid analysis
• Peptide mapping and glycoform analysis
• Extinction coefficient studies
• Liquid chromatography mass spectroscopy (LC-MS)

Blood/plasma testing

• Nephelometry
• HemoX (P50) analysis
• Co-oximetry
• Phospholipids

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.