BioVectra Inc. to Open New Microbial Fermentation and Complex Chemistry Site in December 2017
$30 million investment increases BioVectra’s total manufacturing capacity by 40%
Windsor, Nova Scotia (May 18, 2017) – BioVectra Inc., a Contract Development and Manufacturing Organization (CDMO) providing cGMP services to globally operated biotech and pharmaceutical companies, today announced that its fourth cGMP facility will be fully operational by December 2017. The late-stage to commercial-scale microbial fermentation and complex chemistry facility is located in Windsor, Nova Scotia, with proximity and service to Northeast USA development entities.
BioVectra’s $30 million investment has equipped the 50,000 square-foot facility with 40,000 liters (L) of fermentation capacity, downstream processing equipment and new pre-clinical fermentation and potent chemistry suites. “The investment strengthens our unique position in the very competitive global marketplace, enabling us to offer new and existing clients range of scale throughout the entire lifecycle of a product,” said Oliver Technow, BioVectra’s President.
The new facility is an investment in BioVectra’s core development and manufacturing competencies: microbial fermentation and complex chemistries. As an industry leader in microbial fermentation of both small and large molecules, the company provides scalable cGMP operations from 30 L to 17,000 L. BioVectra has the capability to handle the development and cGMP scale-up of high-potency active pharmaceutical ingredients (APIs), handling potent substances such as antibody-drug conjugate warheads, with occupational exposure limit (OEL) levels of < 20 ng/m3 (Safebridge Band 3 and 4).
The new facility increases BioVectra’s ability to partner with global pharmaceutical companies by offering dual-site risk mitigation. “This expansion helps BioVectra keep up with the growing demand for our products, while also meeting an underserved need for large-scale microbial fermentation in North America,” said Heather Delage, Vice President of Business Development. “In addition to the facility’s large-scale fermentation capability, the site also offers a complementary footprint for synthetic process development and laboratory-based activities.”
BioVectra’s three additional cGMP facilities and headquarters are located in Charlottetown, Prince Edward Island.
BioVectra is a CDMO that serves pharmaceutical and biotech companies with full-service cGMP outsourcing solutions for intermediates and APIs. An innovative and reliable partner with an impressive track record of long-term API supply and a strong quality history, BioVectra has over 45 years of experience specializing in:
BioVectra is a wholly owned subsidiary of Mallinckrodt Pharmaceuticals.
902-566-9116 ext. 6376
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Halifax-based DGI Clinical takes a two-pronged approach to boosting health care: the group gives patients a voice and allows pharmaceutical companies to better understand their clinical trial data.
DGI Clinical has developed systems that allow patients to state and communicate their health care priorities.
Established in 2001 by Dalhousie-based Alzheimer’s expert Dr. Kenneth Rockwood, DGI has created patient-focused SymptomGuides. The Alzheimer’s and dementia SymptomGuide is available online. It allows sufferers to name the symptoms that most concern them. This information can be shared with family and health professionals. Both patients and caregivers can enter data and track symptoms.
It’s important that patients state the symptoms that trouble them, said Chère Chapman, the company’s CEO.
“Gone are the days when patients say, ‘Tell me what to do and I’ll do it,’” Chapman said.
“The SymptomGuide allows patients to set goals for their treatment … One patient with dementia, for example, may wish to increase their social activity. Another may wish to decrease repetition of asking the same questions.”
Chapman said between 4,000 and 5,000 people and their caregivers use the Alzheimer’s and dementia SymptomGuide.
Other Symptom Guides have been created for clinical trials and clinic settings, including a recently developed hemophilia Symptom Guide.
The company has also built bespoke Alzheimer’s and dementia tools for clinical trials and clinic use.
“A company may want to develop a compound to reduce agitation. SymptomGuide will reveal how many of our users are concerned about agitation,” Chapman said.
SymptomGuide can reveal details such as the disease stage or stages where agitation bothers patients, whether respondents are already diagnosed, and what therapies they may be on.
DGI Clinical is now looking at working in the areas of HIV, cardiovascular disease and renal failure.
“Our tools are applicable to chronic diseases, and our scientific team has already done a lot of research in these areas,” said Chapman.
She said DGI Clinical’s tools allow pharmaceutical clients to fully understand their data.
“The typical phase two drug trial looks at primary and secondary outcomes, including quality of life measures, but these are typically analyzed as if they are unrelated,” she said.
“We allow pharmaceutical companies to see how the outcomes interact with each other to produce treatment effects.”
She said that drug companies usually try to exclude frail people from drug trials, but people of different levels of frailty do get onto the trials.
DGI offers a Frailty Index, which was developed at Dalhousie by Ken Rockwood and Arnold Mitnitski, both DGI scientists. It has been adapted for clinical trial data and provides pharmaceutical companies with greater information about the frailty of their clinical trial subjects.
“The Frailty Index reveals the impact of the drug on frail people, resulting in more clinically meaningful information,” Chapman said.
She said that deep analysis of data is especially useful when drug trial results are unclear.
“It could be a $100-million decision to take a drug to the next level, so digging deeper into the data is worthwhile.”
Chapman, a New Brunswick native with a background in health research and business management, had worked around the world before joining DGI a year ago, becoming CEO in December.
She said the company is growing steadily, funding its own growth, and focusing on R&D and hiring staff.
Halifax is an excellent base as the city’s universities produce great scientists. She said she is not aware of any direct competitors.
“Our biggest issue is the education of potential clients,” she said. “We have to get people to change the ways they do things.”
So far, the company has no Canadian clients. All clients are U.S. or European pharmaceutical companies or other groups with a health intervention to test.
“We are not in a huge rush to grow,” Chapman said. “Science is complicated. It takes time for staff to understand all the science behind what we do, however bright they are.”]]>
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