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What to Expect When Outsourcing Process Development?

May 9, 2019

 

The most basic customer expectation for outsourcing processes development (PD) is the receipt of a procedure that meets the requirements for their needs. Discussions about the desired outcome must be set with your outsourcing partner. Achievable targets then need to be agreed upon, after technical consultations occur.

 

 

What to Provide Your Outsourcing Partner

 

Your chosen partner will expect you to provide them with the necessary tools that will help them successfully design and execute your project. After discussions with the PD provider, you should expect to receive a clear proposal from them. This should detail:

 

  • Proposed experimental design
  • Expected timelines
  • Equipment and consumables to be used during the project
  • Project deliverables
  • Legal agreements that govern the collaboration

 

 

What to Expect

 

Projects must proceed in a predictable manner and the final outcomes should be acceptable for both the client and partner. The client should maintain control over the scientific direction of the project. This is accomplished through frequent review of experimental data sets, and approval of experimental study plans prior to execution in the PD partner’s labs.  

 

It is important to keep in mind that process development projects that utilize biological systems often exhibit variability and the initial desired targets may not be reached. However, the process developed should reach acceptable yields that generate enough material to meet customer expectations. Sometimes those goals are not reached and although an optimal yield is not obtained, it does not necessarily indicate that the project has not been successful. Although not optimal, the industrialized process developed during your project can facilitate the drug into preclinical and clinical trials, providing the opportunity to move your product down the drug development pathway. 

 

Depending upon goals and objectives, the process developed should be amenable to translation into cGMP facilities and capable of providing clinical grade product. The type of process you will receive is dependent upon the organization that you choose. Contract manufacturing organizations (CMOs) and contract research organizations (CRO) typically split their focus with CMOs focusing on manufacturing products for clients and CROs optimizing and developing process. CMOs are able to generate material that can be used for preclinical and clinical studies, and also deliver drug products. Some CROs are able to provide materials for toxicology studies which is a benefit to the outsourcing group. 

 

 

Process Development and Project Management

 

Under optimal circumstances, the chosen PD partner will engage in open and honest discussions with you and your team and will provide expert guidance for the development of your process. Project updates and technical discussions should occur at a regular cadence agreed upon by both parties at project initiation but availability to key personnel should not be restricted unnecessarily. Project meetings typically include review of current data sets obtained in experimental studies, technical interpretation of the results provided by your partner, discussion of the implications of the findings with you and your team, and suggestions for moving the project forward. The overall goal of these interactions is to critically review and interpret the data sets so that appropriate next sets are identified and an optimal process is achieved. Logistical updates of the project and review of milestones will also occur in these meetings. 

 

An experienced PD group will provide meaningful direction for your process and will be flexible enough to accommodate and perform experiments that are dictated by the data obtained in studies. 

 

From an organizational perspective, customers should expect to have a project management resource dedicated to their project. This point of contact will guide the logistical aspects of a project, provide expert leadership, and can function as a conduit for communication with the laboratory head and other personnel.

 

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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