Process scale-up of pharmaceutical and biotech manufacturing provides significant challenges with constructability, safety, and compliance – and therefore, cost. Small oversights can lead to delays and significant unnecessary expenses. Our consultants use critical knowledge and experience in production processes and technologies to streamline process scale-ups and get products to patients on schedule.
Process Scale-Up
Our Clients Get Results
Whether “in-house” or working with Contract Manufacturing Organizations, our consultants have demonstrated success in scaling up pharmaceutical and biotechnology manufacturing processes.
Our consultants have consistent follow-through and hold themselves to a high standard of professional results.
We are honest and transparent about our capabilities and are quick to recommend trusted partners to ensure our client’s success.
Teams are Elevated by Our Insights & Attitudes
Our consultants are proactive, positive, forward-thinking, self-motivated, team players.
We embrace and drive change and adoption of highly beneficial new technologies.
Our teams have extensive expertise in all phases of the drug development process, as well as extensive networks to assist with highly specialized issues.
Some Examples of Our Work Performed in 2020
- Researched and designed testing of new technologies for rate-limited production steps
- Storyboard design for a multi-step scale-up
- Filled in critical specialty knowledge gaps
- Streamlined process scale-up
- Proactively predicted and mitigated issues
- Timeline projections and pre-planning avoidance, rectification, or alternatives for known common issues
- Rectified issues likely to result in Form 483’s or FDA warning letters
- Leveraged dozens of trusted industry partners that brought in specialized expertise for scale-up for;
- Facility design
- Novel equipment implementation
- Equipment design
- Equipment specification