CMO Risk Mitigation: From Lab Scale to Manufacturing Scale

Eric SmartBest Practices, Manufacturing

This series of blog posts on CMO risk mitigation has been focused on the challenge of building an effective working relationship with the contractor a pharmaceutical company chooses to manufacture a drug. This third and final post in this series addresses the problem of bridging the gap from the laboratory to the manufacturing floor.

CMO Risk Mitigation: Managing Process Variables

Eric SmartBest Practices, Manufacturing

In the second of this series of three blog posts, the next objective is to identify Critical Process Parameters (CPPs) – the key variables in a production process that affect Critical Quality Attributes.

In sterile product manufacture, CPPs fall into two main categories: Formulation and Fill/Finish

Understand Your Process: A Key to CMO Risk Mitigation

Eric SmartBest Practices, Manufacturing

This post is the first in a series of three on the subject of CMO risk mitigation. Our focus will be to establish methods to reduce project risks when moving from the laboratory to a GMP manufacturing setting.
In these posts we will try to help managers evaluating contract manufacturing to:
-Determine how to work with the CMO to determine critical process parameters;
-Explore strategies to control or eliminate process variables; and
-Learn how to bridge the gap from lab scale to manufacturing scale

Chemical Safety is Designed In

Melanie LewisBest Practices

We began by examining the procedural documentation and training steps a CDMO must take in chemical safety. But some of the most important protective measures can be literally designed and built into to the facilities and equipment.

Chemical Safety Series

Melanie LewisBest Practices, Industry

While finished drug products are intended for eventual human consumption, many of the raw materials and chemicals used to make these products require special safety considerations. Here are some tools to help CDMOs safely manage these important materials:

4 Ways a Client Services Team Can Elevate Your Outsourcing Experience

Kelly BoatmanBest Practices

Client Services is the front door where you and the vendor meet and work together to accomplish your specific service goals. The role of the Client Services team is to fully understand your requirements and then translate those into terms the rest of the organization can act on. If Client Services does their job effectively, they set the stage for achieving the desired results and an exceptional customer experience.

Here are four specific ways that a vendor’s Client Services approach can contribute to the success of your outsourcing experience:

5 Qualifying Questions to Evaluate Solution Providers for Temperature-Controlled Shipping

Travis HudsonBest Practices, Supply Chain Management

Cold Chain Solutions

Life sciences companies with complex warehousing and shipping requirements have a lot of questions – particularly when their requirements include temperature-controlled shipping. For a potential solution provider, it’s not enough just to have a refrigerated warehouse and trucks. The product may not even need refrigeration – it may need to be kept at or near room temperature. How can the pharmaceutical company identify a logistics vendor with the right competency? Here are five basic questions a pharmaceutical company operations manager can use to evaluate a vendor’s qualifications to provide a high-value solution: