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Why Outsource Process Development and Scale-Up?

April 25, 2019

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Why Outsource Process Development and Scale-Up?

 

Market Growth 

 

 

Large pharmaceutical companies are increasingly looking to start-up companies for viable target molecules to fill their pipelines. The number of emerging biotechs has been on the rise over the past decade. This expansion is largely due to the significant increase in new technological discoveries, such as gene therapy and oncolytic markets, cell therapy and biologics. Additionally, there is an inherent desire to cure existing diseases that have long-evaded treatment and the need to combat new emerging diseases. These factors drive the requirement for efficient and streamlined processes for development and industrialization of novel drugs with enabling technologies.

 

Outsourcing process development (PD), bring many benefits. This includes the opportunity and potential to expedite the PD timeline, enabling companies to enter pre-clinical studies faster and to enroll their drug in clinical trials in a time efficient manner. Partnering with single-use and automation vendors, and biopharma organizations will reduce the risk of failing in the late clinical phase.

 

 

Virtual and Semi-Virtual Companies

 

Virtual and semi-virtual companies with academic processes make up a significant part of the emerging biotech space in the gene and cell therapy market. These companies frequently partner with the original inventor of technologies to commercialize therapies or independently license the technologies and molecules from various sources, including universities, medical centers, and academic and research institutions. It is their goal to commercialize or out-license the target molecules in a timely and cost-effective manner.

 

The ability to develop a scalable process and close workflow systems is critical, not only to provide the required quantity of drug for treatment of entire patient populations but also to develop a process that can be executed in a manufacturing facility under cGMP with minimum risk. Outsourcing to a knowledgeable organization will facilitate this process and provide resources to control overall costs of development.

 

Often, these companies do not have sufficient facilities, manpower, cutting edge technologies nor the equipment required to scale up inefficient laboratory generated processes which prevents widespread distribution of regulatory-friendly and cost-effective drugs to market. Process development, production of clinical material, and scale up can be outsourced to a contract development manufacturing organization (CDMO) who have the needed expertise, the resultant process is thus well characterized and scalable.

 

It is critical to maintain robustness, scalability, closed systems, automation, and regulatory compliance of the processes throughout clinical phases. CDMOs have the technical resources and expertise to support these needs for process characterization, scale up, regulatory guidance and tech transfer.

 

 

Benefits of Outsourcing to CDMOs

 

There are many benefits of outsourcing to CDMOs. These include:

 

  • Expertise – CDMOs have the necessary expertise for a scalable, well characterized processes. Well optimized and scalable processes are key to ensure regulatory compliance, lower cost of goods (COGS), and product quality.
  • Flexibility – Having a clinical pipeline with several platforms and scales. When a company doesn’t have in-house capability for processing certain cell lines or platforms, outsourcing becomes a viable option to take the drug molecule through the clinic. 
  • Lower COGS – Increasing pressure for return on investment (ROI) and lower COGS pushes companies to rationalize and limit their resources in-house.
  • Risk mitigation and strategic partnerships.

 

Factors to consider when selecting outsourcing and scale-up partners include:

 

  • Scale of processing 
  • Funding situation of companies (price at CDMO)
  • Platform expertise (mammalian, microbial, insect cell lines, etc.) 
  • Flexibility
  • Aseptic workflow using more automation and close system
  • Availability/space at the CDMO, commercial terms and conditions, reputation of the CDMO etc.

 

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Ruta Waghmare – Vice President, Scientific Affairs and Laboratory Services

Dr Ruta Waghmare is Vice President of Scientific Affairs and Laboratory Services at Pall Biotech. She holds a PhD in Chemical Engineering, and leads a team of ~300 scientific experts. Ruta has co-authored over 65 publications and conference presentations. In her spare time Ruta enjoys practicing yoga and is a qualified children’s yoga instructor.
Dr Ruta Waghmare is Vice President of Scientific Affairs and Laboratory Services at Pall Biotech. She holds a PhD in Chemical Engineering, and leads a team of ~300 scientific experts. Ruta has co-authored over 65 publications and conference presentations. In her spare time Ruta enjoys practicing yoga and is a qualified children’s yoga instructor.
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