WellSpring Publishes Their Second eBook: Technology Transfer Success With A CMO Partner
Posted by Michelle Puglielli
May 11, 2015 11:44:00 AM
Technology transfer is a critical undertaking that can be methodical and smooth. Or, tech transfer can be a nightmare resulting in extensive delays and unexpected costs.
Put in more precise terms, technology transfer can and arguably should be a mature and structured discipline that is repeatable, well managed and predictable. For organizations that do not place importance on the strategic management of tech transfer, the process is most often volatile, unpredictable and fraught with problems.
How Our eBook Can Help
- Robust information exchange
- Careful front-end planning and project management
- Making sure analytical assays are transferred ahead of the process
- Performing verification at the receiving site
- Always perform pre-GMP engineering runs
- GMP runs are the end game
In addition to these six basic elements of success, there are four areas we believe need to be challenged:
- Packaging line trials - if a product is a new SKU to the site, it is crucial to perform line trials, filling the product into the proposed bottle or cap
- Stability indicating methods should already be in place, enabling onsite transfer against the protocol signed off by the client
- Cleaning validation needs to be assessed; specifications and batch records need to be written
- A Health and Safety Review needs to be conducted to ensure the ability to safely handle the product
Within the eBook we explored topics ranging from defining technology transfer within the context of working with a CMO partner, discussion of cost variables, management of analytical method transfer, as well as an overarching exploration of best technology transfer practices.
If you would like more information about other eBooks in the series or you have specific subjects you would like us to write about, please feel free in contacting us at firstname.lastname@example.org. We hope you enjoy it!
About WellSpring Services
WellSpring Pharma Services is a full-service provider of pharmaceutical contract manufacturing and packaging outsourcing solutions for solids,semi-solids, and non-sterile liquids. WellSpring offers full-service contract cGMP manufacturing, packaging and analytical testing services from a single FDA inspected and Health Canada licensed facility.
If your organization is looking for a cGMP facility to outsource your product's manufacturing and packaging, we invite you to visit us and see what WellSpring can do to meet your product outsourcing needs. Technologies and processes may change, but WellSpring’s core commitment to quality, compliance, and customer service remain constant. We are ideally located one hour from Boston, New York City, Chicago and Philadelphia via Pearson International Airport in Toronto. No matter where you are in the world, doing business with WellSpring is easy.
Topics: Organizational Announcements
Michelle is a Project Manager of Pharma Services in WellSpring’s Business Development Department, with previous roles in Stability and Research Development as a Program Coordinator, and Quality Control positions in the Chemistry and Microbiology laboratories. Michelle has been with WellSpring since graduating from the University of Waterloo, where she earned her Bachelor of Science Undergraduate Degree. She is currently responsible for managing commercial and clinical CMO projects.