BIOVECTRA

CDMO

Innovation

Q2 2016

Track Record

<h3>Most pharmaceutical and biopharmaceutical companies  are establishing closer relationships with a few select service providers that have unique combinations of capabilities  and demonstrated performance.</h3>
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<p>To be successful, contract development and manufacturing organizations (CDMOs) must be forward thinking — constantly anticipating the future needs of potential customers and investing in state-of-the-art facilities, equipment and technologies. To attract those customers, CDMOs must also have a very strong track record of performance with respect to the quality of the products and services, their ability to meet project objectives and timelines, and their regulatory compliance history – all combined with advanced and specialized capabilities. A commitment to transparency, open communication, true collaboration and a genuine respect for the needs of each client’s individual projects has also become essential for CDMOs that want to participate in strategic partnerships with their customers. BioVectra Inc. does all of this and more.</p>
<h4>Strong History Of Performance</h4>
<p>While outsourcing provides many benefits to drug manufacturers, including access to needed capacity and technical expertise, the ability to convert capital expenditures into operating expenses, and the opportunity to increase productivity and cost efficiency, it also carries a significant amount of risk. CDMOs that present mini- mal risk through demonstration of consistently high performance, combined with the needed technical expertise are most likely to be selected.</p>
<p>BioVectra has been providing a unique combination of synthetic organic chemistry and fermentation of chemical and bio- logic molecules — including highly potent compounds, downstream processing, me- thoxypolyethylene glycol (MPEG) production and conjugation chemistry services — for more than four decades to small and large pharmaceutical, biotechnology, generic, and early stage companies. R&amp;D to commercial-scale quantities of cGMP raw materials, intermediates and active pharmaceutical ingredients are produced at three facilities on Prince Edward Island, Canada, all of which are regulatory audited by the FDA, Health Canada and the Japanese Ministry of Health.</p>
<p><img loading="lazy" src="http://thatsnice-testing3.com/legacy/Q2_%202016/Sidebar%20Images/16Q2_BioVectra_Sidebar1.jpg" alt="16Q2_BioVectra_Sidebar1.jpg" width="716" height="648"></p>
<p>The company has submitted 10 product filings, including ANDA, DMF, VMF and CMC section preparations for both the FDA and Health Canada. Through various partnerships, BioVectra has developed challenging new entities and generic products, including particulate injectable formulations with highly potent and cytotoxic active ingredients, controlled release products, and APIs semi-synthesized from metabolites via highly challenging fermentations. Its extensive capabilities in the handling, processing, and quantifying of APIs from natural sources have been applied to the isolation of domoic acid from mussels, adenosine deaminase from bovine sources, and taxanes from yew trees. BioVectra also offers cGMP bioprocessing reagents, such as dithiothreitol (DTT) and tris (2-carboxyethyl)phosphine hydrochloride (TCEP-HCI), and develops custom solutions for MPEG functionalization using proprietary, scalable chemistries.</p>
<h4>Specialized Yet Diversified</h4>
<p>Production of the advanced therapies un- der development today often requires a wide range of specialized capabilities. Many of today’s drug candidates require both biologic and small-molecule production and purification capabilities, as well as expertise in pegylation and conjugation chemistry. Even so, most CDMOs have elected to focus either on biotechnology or small-molecule chemistry, and few can offer a combination of both.</p>
<p>Since its inception as a manufacturer of biological reagents, BioVectra has been evolving to meet its customers’ needs. The addition of cGMP manufacturing capabilities for DTT and other reagents required the development of expertise in scaled chemical manufacturing, and the company continues to develop synthetic and analytical methods for customized bioprocessing reagents. During this period, the company also developed expertise in the extraction, handling, and quantification of APIs (chemicals and proteins) from natural sources. By natural extension, BioVectra developed expertise in microbial fermentation for the production of metabolites, in particular using filamentous fungal and bacterial strains, native and recombinant bacteria, and salt water microbial organisms. Many of these products were highly potent, which led BioVectra to develop specialized facilities, equipment and procedures for the safe production and handling of potent compounds. Application of the company’s core synthetic chemistry competencies for downstream chemical modification and purification of secondary metabolites was the next step in the company’s evolution.</p>
<p>As a result, BioVectra has a unique combination of capabilities — it is in fact a highly diversified CDMO offering a range of very specialized technologies. With this technical profile, BioVectra can serve as a single development and manufacturing partner for pharmaceutical companies developing novel therapies that require expertise in the processing of both small and large molecules. In addition, these services are available at R&amp;D to commercial scales, allowing customers to avoid the time and cost associated with technology transfer from one service provider to the next.</p>
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<h4 class="callout-title">Production of the advanced therapies under development today often requires a wide range of specialized capabilities.</h4>
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<h4>Investing For The Future</h4>
<p>Innovation lies at the heart of the pharmaceutical industry, and CDMOs must keep pace with their customers. That requires the ability to anticipate future client needs and the willingness to invest in new capabilities. BioVectra has, throughout its history, worked closely with its customers, installing capacity and building expertise to meet their needs. More recently, the company has aggressively invested in capacity expansions around its core competencies of fermentation and down- stream processing. Expenditures from 2014 through 2016 totaling more than $50 million include the following: acquisition of the former Sepracor API production facility located in Nova Scotia, Canada; installation of an additional 30,000L of fermentation capacity (for a total of 60,000L); installation of improved down- stream purification equipment to support existing fermentation capacity with specialized capabilities in potent intermediate and API purification processing; in- vestment in new preclinical fermentation and potent chemistry suites; and the addition of 13,000 square feet of laboratory, office, workstation, and meeting space for its growing workforce.</p>
<h4>New Leadership Team Focused On Growth</h4>
<p> In addition to these investments, BioVectra also recently brought Oliver Technow on board as President to guide the company through its next phase of development. With his extensive experience in commercial development and marketing, brand, and life cycle management for various global pharmaceutical companies, Mr. Technow has a unique perspective on the needs of CDMO customers. This market understanding, combined with the extensive knowledge of the company’s long-serving business development and technical leaders, will help BioVectra expand its partnerships with existing customers and develop new collaborative relationships.&nbsp;</p>
<h4>About The Authors</h4>
<p><strong>Oliver Technow</strong><br />President, BioVectra<br />With more than 20 years of global pharmaceutical industry experience, Oliver Technow, President of BioVectra, has held numerous leadership positions in commercial development, marketing and brand management and life cycle management in Europe and North America, and was appointed President of BioVectra Inc. in December 10, 2015. He holds an industry master’s degree from Frankfurt Chamber of Commerce, Frankfurt Germany.</p>
<p>LinkedIn:&nbsp;<a href="http://www.linkedin.com/in/oliver-technow-b1b26a13?">www.linkedin.com/in/oliver-technow-b1b26a13?</a><br />Email:&nbsp;<a href="mailto:otechnow@biovectra.com">otechnow@biovectra.com</a></p>
<p><strong>Scott Doncaster</strong><br />Vice President, Manufacturing Technologies and Engineering, BioVectra<br />Since joining BioVectra in 1995, Scott Doncaster, Vice President, Manufacturing Technologies and Engineering has demonstrated his leadership supervising enzyme and natural products bioextraction process operations. In 2000, Doncaster was promoted to Operations Manager, to Director of Manufacturing in 2005 and to his current role in 2014. He holds a B.Sc. in biochemistry from Mount Allison University in New Brunswick, Canada.</p>
<p>LinkedIn:&nbsp;<a href="http://www.linkedin.com/in/scott-doncaster-7177b813?">www.linkedin.com/in/scott-doncaster-7177b813?</a><br />Email:&nbsp;<a href="mailto:sdoncaster@biovectra.com">sdoncaster@biovectra.com</a></p>
<p><strong>Heather Delage</strong><br />Vice President, Business Development, BioVectra<br />Heather Delage Vice President, Business Development for BioVectra has 25 years of experience in marketing management, project management, and business development in the pharmaceutical, biotechnology, and clinical diagnostic industries. She holds a B.B.A. with concentration in marketing from University of Prince Edward Island.</p>
<p>LinkedIn:&nbsp;<a href="http://www.linkedin.com/in/heather-delage-1b5ba710">www.linkedin.com/in/heather-delage-1b5ba710</a><br />Email:&nbsp;<a href="mailto:hdelage@biovectra.com">hdelage@biovectra.com</a></p>
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Establishing Specialized CDMO Capabilities for the Production of Advanced Therapies