Challenges of Scale-Up Process and What You Should Consider

Key Equipment, Safety Concerns, Regulatory Compliance, and Understanding of Raw Materials

Is Your Scaling-Up Partner Ready for Scaling-Up Challenges?

New drug development requires a seamless scale-up process and to carry out this process, it is crucial to understand potential challenges during the scaling-up process.

Is your partner aware of the batch size? How about contamination risk? Does your partner comply with regulations when scaling up an option? The drug substance manufacturing process must be scalable from a technical, safety, and economic viewpoint.

Equipment Designed for Scalability

Versatile Scalability from Pre-Clinical to Commercial Production Level

One of the first things you should consider for the scaling-up process is how large a batch size you will need. You will have to adapt to new or modified equipment to handle the larger batches. Therefore, it is important to first understand how large-scale equipment will change your process.

Robust Manufacturing Process Ensuring Regulatory Compliance

Maintaining quality - It is also required to ensure that there are enough Good Manufacturing Practices (GMP) steps within the manufacturing process to meet regulatory requirements as well as to ensure quality throughout the scale-up process. This includes establishing strict Quality Control (QC) measures and paying attention to process development and validation.

Safety Concerns During the Scale-Up Procedures

Safety is a crucial concern for pharmaceutical companies looking to increase manufacture.

Potential contamination - During the transition period from small to large-scale manufacturing processes, most pharmaceutical companies face problems with possible product contamination due to the new processes. Not only the product but also the safety of operators can be at risk as they might confront with a greater volume of potentially hazardous materials while scaling up production.

Therefore, the scale-up partner should be fully equipped with high containment systems to protect the safety of operators and the product.

Understanding and Efficient Use of Raw Materials

One of the challenges of scaling up is that raw materials can vary in quality and composition. This can have a significant impact on the manufacturing process, so it is important to understand how different raw materials will affect your manufacturing.

For instance, when progressing a drug substance from milligram to kilogram quantities, there are characteristics of the drug substance that can impact formulation.

Know-how of handling raw materials is essential as the quality and composition of the materials change throughout the scale-up process

Time is a key factor in the scaling-up process. Your partner must have strong pharmaceutical development and manufacturing process parameters to take a product to market on time.

Dec Group is a one-stop point for an End-to-End solution provider - handling from the raw materials to the aseptic Fill-Finish process including containment systems. Our aseptic filling solutions are fully tailored to meet the demands of various sizes of pharmaceutical companies, CDMOs, clinical research organizations(CROs), and R&D.

From laboratory to production scales, Dec group guarantees seamless and effortless scaling-up.

To find out what the Dec group is capable of, check out our recent article: Why are Dec's True End-to-End Solutions Unique?