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 protein-based products with clients’ product specific knowledge to create a cost-effective 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 in-process 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, HEK-293, 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 pre-filled 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 pre-filled 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 pre-inspections. 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, walk-in 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.

Developing Biopharmaceuticals

Located in Mississauga, Ontario, Therapure Biopharma is an integrated biopharmaceutical company that develops, manufactures, purifies, and packages therapeutic proteins.

It’s not as complicated as it sounds. If you ask Thomas Wellner, President and CEO of Therapure, he explains what his company does in easier terms. In his words, “Therapure’s primary business focus is to perform contract development and manufacturing services (CDMO) for biotech and pharmaceutical companies. The company specialises in biologics, which are different than pills or small molecules. Biologics are gleaned from a living source; for example, a cell, bacteria or an animal.” Consistency of manufacturing is critical for biologics since the process starts with a living source.

Therapure attracts large, multinational pharmaceutical and biotech customers, as well as small, start-up biotech companies. Providing development and biomanufacturing services allows Therapure to stay at the forefront of biomanufacturing techniques, ensuring clients benefit from both depth in the scale up of a manufacturing process, as well as the breadth of potential sources to manufacture biologics. The second aspect to the business is pursuing their own discovery research—also focused on biologics.

“We are developing a set of products that is focused around using haemoglobin—the body’s most abundant protein—as a drug carrier,” explains Wellner. “We attach drugs to haemoglobin and it naturally transports the drugs to organs like the liver, spleen and bone marrow. It’s an efficient use of a natural process to get a drug to the body. Therapure is also doing development work for rare blood disorders, bone growth and bone regeneration.”

The product side is still in its early stages of development. Some of their products won’t go into the clinic for testing for another year or two. Even after that, they won’t be approved for a while. “The drug approval process is at least five years,” Wellner says. “You have to do clinical work just for proof of concept and then you need to perform pharmacokinetic toxicological studies that are required by the health regulators to allow you to go into Phase One clinical studies in healthy volunteers.”

Phase One involves trying the product on a healthy person. Phase Two looks at a few people with a particular disorder, and in Phase Three, you do tests on a broader population to make sure it’s safe and efficacious. “After all that, you provide the data that’s been analysed to gain marketing approval. And that process can take six to eight years and many millions of dollars,” says Wellner.

Industry Trends :-

As research, technology and knowledge advance, the medical industry experiences constant change. One of the major trends that has been significant for Therapure Biopharma is the growth in demand for biologics. “The growth has been tremendous in vaccines and monoclonal antibodies,” says Wellner. “The biologics industry is growing at three times the rate of general growth in medicine. Biologics are being used to target diseases and areas of the body that previously couldn’t be treated.”

Another positive change affecting the company is the desire to outsource. Ten years ago, pharmaceutical companies did everything inside their own walls, reluctant to use service providers. Due to the economic climate, there has been a shift in the way pharmaceutical companies are spending. “They are trying to use capital in the areas they’re good at and outsource for non-core areas,” Wellner explains. “The trend to partner with biomanufacturing and drug development services has been great for us. That’s why we’re in the services business, because the trend has been so strong.”

Will the trend reverse when the economy turns around? Maybe not. Wellner believes it’s sustainable. It might be the industry is realizing that this is an efficient way to focus their capital on high-value areas, while allowing competent service providers to provide support.

No matter what industry, money is always a concern. Who pays for particular products in the system is something that is certainly becoming more prevalent, as is building a case for financial support. Twenty years ago, there was a lot more freedom around what a system would provide and pay for. In his last 10 years, Wellner has seen a real tightening on which products gain support and approval for funding from centrally funded Government systems.

“Now, you have to spend a lot more time providing health-economic information and arguments that are non-scientific in nature,” says Wellner, “You have to include a cost-benefit analysis. For us, it’s difficult yet important because the types of products that we’re involved in are usually unique, expensive and specific to rare disorders. The use of these products is being controlled and it is more challenging to get them paid for.”

Ramping up :-

As Canada invests more in developing its healthcare and medical industries, Therapure Biopharma, a Biotech Manufacturing organization is one of those companies that is sure to succeed since the company provides high-value services which are not widely available from one service provider. Positioning itself for that success, Therapure is aggressively ramping up their client base to build revenue.

“We have invested a lot of time, capital and effort into getting our facility up to full capacity so we want to make sure our cash in is equal to or exceeding our cash out,” reasons Wellner. “We booked positive revenues last year and we have an aggressive revenue growth plan for 2009 and beyond.”

“The long-term goal is to continue to see that services revenue grow and to have some of the early investments start to bear fruit,” Wellner concludes. “Some of the internal developments and joint-development products will start to create some additional uplift for our business that will allow us to continue to grow nicely. Eventually, Therapure wants to be a fully integrated biopharmaceutical company that provides both services to others and also has our own innovative products to sustain long term growth.”