The increasing relevance of global markets, especially emerging markets, is causing an increase in the number of manufacturing sites within a company. Instead of centralized manufacturing sites shipping worldwide to customers, manufacturing is becoming regionalized and closer to customers. With that, the following challenges are magnified:
Lack of resources
One struggle when starting up new manufacturing sites is finding the highly skilled experts needed for the industry.
Lack of experience with single-use systems
The increasing use of single-use systems (SUS) to run entire processes within GMP manufacturing is creating the need for SUS expertise
Process risk
Lack of experience and expertise can introduce risk to the drug manufacturing process or add to the risk of product contamination.
Redundant resources
While coordinated efforts are more likely to happen on the research side, collaboration does not always occur with manufacturing.
Higher costs
Customized processes and technologies for each manufacturing site add costs in a number of ways.
Globalizing Best Practices and Specifications
Ultimately, to address the challenges above, global coordination is needed. Best practices and specifications need to be identified and implemented across manufacturing networks. This is referred to in the biotech industry as developing platform technologies, harmonization, or technology standardization.
How to Implement Global Standards
Form a Global Standards Team
The key is to form a team - typically this is a multi-department group that interfaces with the most number of manufacturing sites.
Collect and House the Expertise
One way to promote sharing of internal expertise is the formation of a group of multi-site SMEs (subject matter experts), often referred to as a community of practice.
Anticipate the Challenges
A challenge to the global approach is overcoming individual employees’ perceived ownership of company expertise.
Allow Flexibility for the Needs of the Business
The benefits of harmonizing across global sites are very powerful and compelling reasons to initiate such a program.However, it’s important to recognize the risk of forcing standards when an alternative is needed.
Read the white paper
For more details, read Jason Nisler's white paper, "Implementing global best practices and technology specifications for single-use systems".
Additional Resources
Products: AseptiQuik/Sterile
If you would like to learn more about CPC's single-use connectors OR any of our products, please complete the form, and a CPC representative will be in contact with you.