As a virtual pharmaceutical company, bluebird bio relies on contract organizations to perform key functions such as testing, manufacturing, and research. With all of these activities performed offsite, it is critical that the company stays closely aligned with partners to develop or update treatments.
 
Gene therapy is an emerging field that moves quickly, and manual processes are too slow and not scalable. With a cloud-based quality solution, pharma and biopharma companies can directly engage with contract organizations such as contract manufacturers (CMOs) – streamlining communication, accelerating processes, and gaining greater operational visibility.

Bluebird bio is a clinical-stage company developing gene therapies for severe genetic diseases and T cell-based immunotherapies. The company’s integrated product platform encompasses gene therapy, cancer immunotherapy, and gene editing. The company is headquartered in Cambridge, MA, with approximately 375 employees in the US and Europe.

Contract Pharma: What are some of the challenges CMOs face in today’s technology environment?
 
Jacquelyn Chuk: Many organizations still rely on a mix of manual processes, disparate systems, email, faxes, and paper documents. This causes a great deal of complexity and inefficiency in the way internal teams and external partners work together. It makes simple processes more difficult, such as reviewing and approving procedures, test methods, product changes, or any other activities that require approval by both parties throughout the product lifecycle.
 
Another big challenge is the inability for a sponsor to bring external partners into quality processes and access its quality systems. Technology has come a long way and is now capable of unifying these parties to seamlessly support end-to-end processes. However, a culture shift still needs to happen in how organizations think about leveraging modern systems with their partners.

CP: In what areas do CMOs face efficiency issues?
 
JC: The sheer volume of information CMOs must track and share with clients continues to grow, driven by increased regulatory oversight from sponsors. Each CMO may manufacture multiple products for a client. And with multiple clients, the amount of information CMOs manage is staggering. Any delays can hinder them from meeting key business deadlines, negatively affect client relationships, and impact their top or bottom line.
 
Two areas that are significantly impacted are collaboration and audits. Pharma companies like bluebird bio are ultimately responsible for overseeing the entire product development lifecycle, even when contracting work to CMOs. To successfully manufacture and update products, there are a number of documents and tasks that must be reviewed and approved by both parties, which can be a lengthy process. There is a lot of back-and-forth communication, to ensure everyone has reviewed the right information and received the most recent documents. And once a document is approved, getting it signed is also very cumbersome with paper documents and wet signatures.
 
Audits are another area that could be vastly improved. CMOs are under pressure to respond to audits in a timely manner. Most of this is done manually through emails, attachments, portals, file shares, and even paper. This makes it difficult to know the status of where things are in process and to remind people of tasks or escalate issues.
 
CP: How can technology help overcome these challenges?
 
JC: Technology can facilitate seamless interactions between CMOs and sponsors. For content where bluebird bio and the CMO have a mutual stake, we provide the partner a license to use our cloud-based system for easier collaboration, revision, and approvals – all from a single location.
 
We’ve found the platform to be very intuitive and easy for CMOs to use. With a simple “work instruction” guide that includes screenshots, CMO users are able to quickly access the system and perform activities.
 
Using cloud-based technology, both bluebird bio and our CMO partners have dramatically reduced basic and manual tasks while streamlining workflows and processes, freeing employees and CMO partners to stay focused on innovation.
 
CP: Are you able to satisfy regulatory requirements leveraging modern cloud-based technology?
 
JC: Absolutely. Since replacing manual and paper-based processes with cloud-based technology, we’ve made it easier for our staff and CMO partners with faster review and approval on key processes, while staying compliant. Technology helps us maintain maximum agility and speed in order to keep pace with the quickly evolving world of gene therapy.