When do you start a conversation with a CMO: Within 4 weeks, you can find your BUDGET for manufacturing

Prestige Biologics offers a <4-Week BUDGET ESTIMATION PROGRAM>.
Regardless of the stage of your biopharmaceutical pipeline, through our estimation program, you can assess the required budget and production technology to predict and prepare for the future. Discover cost-effectiveness strategies with us as your CMO/CDMO partner. Within 4 weeks, you can confirm the budget you need for the future.

When do you start a conversation with a CDMO?

In the biopharmaceutical industry, the process of discovering, developing, and commercializing drugs brings significant pressure with extensive tasks. Specifically, considerations regarding the establishment of production technology and product manufacturing at each clinical stage may sometimes take a backseat due to daily demands. 
However, actively involving various Contract Manufacturing Organizations (CMOs) and seeking diverse opinions from the early stages can result in positive outcomes for future business development. Requirements in the production field may vary from those in the development stage, and the timing of involving CMOs can fluctuate with the pace of clinical research. Furthermore, unforeseen technological changes can cause delays in both technical and equipment preparations for production. Securing enough time for exchanging various questions and answers with CMO is crucial. Additionally, it is essential to assess the scope of the budget beforehand. Please inquire about your budget in various scenarios and environments. The assurance of proactive conversations in CDMO is crucial.

When is the most optimal timing to consider the production of your biological product under development and clinical trials like follows: 1. Research and Development (R&D) Phase2. Phase I Clinical Trials3. Phase II Clinical Trials4. Phase III Clinical Trials5. Pre-approval and Post-approval Activities6. Market Launch

We have to consider lots of issues, which are related with production, beyond drug development and research. This includes determining the proper batch size for cost-effectiveness, proceeding scale-up studies based on the determined batch size, selecting appropriate suites according to production scale, researching and deciding on additional equipment to enhance efficiency factors such as yield, establishing technical requirements through meetings with Contract Manufacturing Organizations (CMOs) during Technical Transfer, auditing CMO production facilities, negotiating and reaching agreements for reasonable pricing, deciding on systems and tools for efficient communication between customers and CMOs, determining data exchange methods, and reviewing the supply chain for raw materials and consumables. 

As a CMO, based on our experience, there is no one-size-fits-all answer to the best timing for considering production. It depends on your research activities and market access strategies. Sometimes, it's advantageous to initiate contact with a CMO in the conceptualization stage to establish a framework for budget and technology. In other cases, discussions with external partners like CMOs might need to start at a much later stage, especially for the sake of confidentiality protection. 

However, regardless of when you start discussions with a CMO or external partner, you will gain valuable insights into your business strategy through this engagement. These insights may include the budget range, methods to achieve better cost-effectiveness, ways to manage production schedules effectively, strategies for improved communication, and predictions regarding the relevant workforce. Additionally, securing options that can provide a more economical production environment is inherent.

Meeting with a CMO earlier to discuss cost-effectiveness allows you to make better decisions for commercial production. Whether you choose to engage with a CMO in the early stages or later, you'll benefit from a deeper understanding of how to optimize your production processes economically.

Embarking on the journey with a CDMO is a strategic move towards ensuring top-notch outcomes for your projects.

Your journey towards success begins with us. Trust in our dedication to quality, embrace the advantage of competitive pricing, and let our expert project management guide you seamlessly through your projects. Contact us today, and let's shape the future together.

Connect you to the JOURNEY FINDING BUDGET: [email protected]