Novasep

Cell and Gene Therapy

Preclinical

Q1 2019

Viral Vector

Viral Vector Manufacturing

<h3><span style="color: #458cb2">As gene and modified cell therapies advance rapidly through the clinic to commercialization, drug developers are looking to secure commercial production capacity. Novasep has combined its extensive experience in viral vector manufacturing with significant investments in expanded drug substance and fill-finish capabilities.</span></h3>
<h4><span style="color: #5fa3c8">Rapid Growth in Demand for Viral Vectors</span></h4>
<p>The global market for viral vector manufacturing, including retroviral vectors, adenoviral vectors, adeno-associated viral vectors and other viral vectors, is expanding at a compound annual growth rate of 20% from $327.8 million in 2018 to $815.8 million by 2023.<sup>1</sup></p>
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<p>The promise of treating and potentially curing diseases previously thought to be untreatable is leading pharma companies to invest in the development of gene and modified cell therapies, many of which are proving successful and advancing rapidly through the clinic.&nbsp;</p>
<h4><span style="color: #5fa3c8">Concern Over Commercial Manufacturing Capacity</span></h4>
<p>This rapid advance is leading to significant concern that commercial manufacturing capacity will be insufficient for a potentially large number of products that may be approved in the near future. Biotech companies with drugs moving into late-stage clinical trials are already looking to secure commercial manufacturing capacity in the event that their candidates receive approval. These companies are also seeking partners with both drug substance and drug product manufacturing capabilities in order to streamline project timelines and costs.</p>
<h4><span style="color: #5fa3c8">More than Capacity Needed</span></h4>
<p>Manufacturing of viral vectors is more complex than the production of protein-based biologics. While suspension cell culture is appropriate for some vectors, adherent cell culture is necessary for many others. The latter requires specialized equipment and expertise in processing conditions and is generally much more labor and equipment intensive.</p>
<p>Particularly in the case of AAV (adeno-associated virus), the ratio of empty to full capsids must be minimized, requiring the development of customized separation processes. In addition, viral vectors have complex structures and can be very fragile (e.g., lentiviral vectors). Maintaining their structure during processing (formulation, sterile filtration and filling) and ensuring high recovery rates and yields can be quite challenging.</p>
<p>Experts in biologic manufacturing, as well as virology and analytic method development, are essential to the establishment of efficient viral vector manufacturing processes. Analytical scientists must have experience with a wide array of methods and assays, from qPCR and chromatographic techniques to activity and potency assays. Each method requires customized development for each viral vector project.&nbsp;</p>
<p>Gene and cell therapy companies looking to outsource viral vector manufacturing should seek out service providers that not only have the required capacity for drug substance and drug product production, but the experience and expertise necessary to develop optimal processes for their specific viral vectors. Extensive regulatory support is also often necessary, making it important to find partners that have experience working closely with regulatory agencies.</p>
<h4><span style="color: #5fa3c8">Broad and Deep Experience at Novasep</span></h4>
<p>Novasep has a track record of developing successful processes for the production of nearly all classes of viral vectors that can be used in therapeutic applications. This experience has allowed us to develop a platform/thematic approach to process development, streamlining production and scale-up. We have also acquired experience in transferring the production of viral vectors from adherent mode to suspension mode, reducing the number of constraints and enabling production of larger quantities.&nbsp;</p>
<p>In addition, we have completed projects that span the full development cycle from preclinical to nearly commercial and have a full range of capabilities in terms of scale, from low-volume up to 2000-L bioreactors. We also have demonstrated the ability to produce both viral vector drug substances and drug products for clinical manufacturing.</p>
<h4><span style="color: #5fa3c8">Backed by Expanded Capacities</span></h4>
<p>These capabilities are being expanded with the recent investment in a €27 million viral vector production facility at Novasep’s Seneffe, Belgium site. Two cGMP suites are included, one each for adherent and suspension cell culture of drug substances. Both are designed for projects in phase III and commercial stages. These suites are in the final stages of qualification and will be operational in the second quarter of 2019.</p>
<p>Novasep is also constructing a fill-finish commercial facility for manufacturing viral vectors and other biologics at the same site, which will be operational by the third quarter of 2019. With both drug substance and drug product manufacturing co-located in the same facility, Novasep can provide standalone or integrated services.&nbsp;</p>
<h4>References</h4>
<ol>
<li><em>“Viral Vector Manufacturing Market worth $815.8 million by 2023.”</em> MarketsandMarkets. Aug. 2018. Web.&nbsp;</li>
</ol>

Preclinical to Nearly Commercial Virus and Viral Vector Manufacturing