BioPharm International - February 2020

BioPharm-Outsourcing eBook

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www.biopharminternational.com February 2020 BioPharm International eBook 9 addition, outsourcing enables organi- zations to manage their cash flow. One example is manufacturing, where the use of contract develop- ment and manufacturing organi- zations (CDMOs) provides not only additional competencies but a de-risk- ing of the investment. At early stages of still invalidated technologies or products, it may be of significant risk to establish large 'in-house' structures that carry significant cost associated with the risk. An outsourced invest- ment enables the product developing companies to progress with the tech- nology at reduced risk with cash flow management. Nyamay'antu (Polyplus-transfection): CGT developers are booming and viral vector large-scale manufacturing is short of capacity. The majority of developers from small biotechs and even from Big Pharma rely on out- sourcing partners, including contract manufacturing organizations (CMOs, CDMOs) with extensive experience to accelerate the journey of their drug product from bench to market. This choice is governed by the fact that significant capital investments are necessary to build dedicated viral vector manufacturing facilities for commercialization, as well as require ma nufac t ur ing a nd reg ulator y expertise to upscale manufacturing in compliance with good manufac- turing practices (GMP) guidelines. Outsourcing partners put forward their process development know-how to meet the needs of developers. They usually put forward the flexibility and adaptability of their viral vector manufacturing platform: adherent or suspensions cell culture systems, established process development for various viral vectors, and scalability of production for pre-clinical to com- mercial product supply. Lakelin (TrakCel): There are a num- ber of benefits to outsourcing the development of advanced therapy medicinal products (ATMPs), and we continue to see outsourcing of key processes taking place. One reason for this is the shortage of manufactur- ing facilities available to the sponsor. While we see a number of biotech's investing in in-house manufacturing facilities, there are many that opt to use CDMOs to assist in the manu- facturing stage of product develop- ment. As a result, outsourcing can provide benefits that include quality, efficiency, productivity, and a quicker 'time-to-market'. A VARIETY OF CHALLENGES BioPharm: Could you highlight some of the challenges facing outsourcing partners to be able to effectively meet the demands of CGT development? Nyamay'antu (Polyplus-transfection): CGT developers rely on contract manufacturers to produce their ther- apeutic viral vectors at a larger scale with quality, reliability, and effi- ciency. One specific challenge that an outsourcing partner needs to address and that impacts all of the aforementioned requirements is sup- ply of raw materials. Production of therapeutic viral vectors is dependent on a great number of complex and specialized raw materials, of which cell culture media, cell lines, plasmid DNA, and transfection reagent are particularly important. Lakelin (TrakCel): The products that we see day-to-day have very differ- ent supply cycles and different chal- lenges associated with them to more traditional therapies. For autologous therapies, there are certain require- ments of the treatment process such as Chain of Custody (CoC) and Chain of Identity (CoI) that must be adhered to that can present chal- lenges. The personalized nature of these therapies relies upon the abil- ity to track and identify product as it moves through the circular sup- ply cycle and back into the patient. In addition to these challenges, we believe that manufacturing cost of goods is an issue that the industry is trying to reduce. Forte (Bone Therapeutics): The most important factor in the success of an outsourcing partnership rests on the cultural fit of both organizations. It is crucial that the outsourcing orga- nization understands, adapts, and responds to the size, needs, and stra- tegic growth of the in-sourcing part- ner. The partnership needs to operate in a clear team spirit even though the roles and responsibilities are defined and well respected. An efficient and adapted way of working together is critical for success. Clearly the outsourcing partner has to have the right competencies and talent to provide the required services. This requires access to tal- ent, which may prove a challenge in view of the limited availability of trained talent in the CGT field. Leading organizations in the sec- tor are making conscious efforts to provide training and an 'educating home' to raise the availability of required talent. Different sources of outsourcing services also require access to state-of- the-art technology and equipment, which frequently is owned and man- aged in between both insourcing and outsourcing organizations. Finally, there are the challenges in the field, in general namely regarding clinical development and clinical tri- als implementation, regulatory, mar- Partnerships for Outsourcing Development "CGT developers are booming, and viral vector large-scale manufacturing is short of capacity." —Alengo Nyamay'antu, Polyplus-transfection

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