Scitara DLX™ can help ensure flexibility, precision and a successful outcome in the end-to-end pharma supply chain
- Where multiple labs need to repeat the same process, the most important success factors are governance, automation, and communication
- The automation enabled by Scitara DLX™ Orchestrations facilitate transfer between laboratory systems to yield a reproducible process
- The Covid-19 pandemic provided an example of how laboratories can adapt quickly, whereby innovator labs transferred manufacturing technology swiftly to expand world-wide vaccine production capacity
“We’ve done that before” is a compelling argument for success that a pharmaceutical company or one of its Contract Manufacturing Organizations (CMOs) can make when bidding on a new project. But in many cases, such an argument is impossible to make, such as in the case of manufacture of a highly specialized novel drug, or more recently, during a public health emergency where certain pharmaceutical CMOs—which had not previously manufactured vaccines—were called into action, either through a pharma company contract or through government mandate. In such cases the pharmaceutical industry needs to add flexibility in the technology transfer to its list of needs. The specifics of what the CMO has or has not done in the past may be less relevant than the contract governance process, the level of automation and oversight in the technology transfer process, and the rigor and precision of communication between all parties.
Transparency, Communication, and Data Sharing
Technology transfer is a common practice in the pharmaceutical industry and is simply defined as the practice of transferring scientific processes for scale-up or production. That transfer may occur between the pharma company and third parties, partners, or CMOs, or even between departments within the same organization. Simply put, technology transfer is just another term for efficient collaboration and uniformity of process.
Within the transfer process, success is dependent on several factors, including meeting all KPIs as defined by the innovator lab, such as purity and potency, as well as an affordable cost, an acceptable rollout time, and with adherence to all GxP practices and other regulatory compliance factors. Traditionally however, this process has relied heavily on manual processes, but as the process grows in scope, this approach quickly becomes untenable and an automated and reproducible process becomes essential.
The transfer process is dependent on several factors, many of which are facilitated by Scitara DLX:
- An automated and enforced workflow, implemented via DLX Orchestrations
- A robust audit trail
- The ability for multiple parties to “get up to speed” quickly on laboratory processes
- Validation of all manufacturing processes, test methods, and associated software, both in the innovator laboratory and receiving facility
- Enhanced reliability and error avoidance
- Effective communication among all parties
Regulatory compliance requires a reproducible, documented process which applies to all parties involved. Although automation is not necessarily required as part of regulatory compliance, it contributes to the same end goal while also increasing the level of accuracy. Orchestrations in Scitara DLX ensure a higher level of automation, documented processes, an audit trail for an archival record of all events, and an event stream to show all user logins, password change operations, and user actions. Scitara DLX imposes a layer of connectivity between devices or applications that is often absent in manual laboratory processes.
Maintaining a flexible environment in a system which, to a large extent, demands rigidity may seem to be conflicting advice, but that flexibility is precisely what is needed to ensure efficiency. The any-to-any connectivity enabled by DLX Orchestrations allows for easier connectivity between devices that, without DLX, would require manual transcription of results as well as manual processes that are more prone to error and consume more resources during the review process.
This flexible environment – which ensures that “no instrument or application is left behind” – becomes very useful in technology transfer, to ensure that both parties in the transfer adhere to the same process without the possibility of deviation. Also, in cases where the second lab may not have the same equipment as the first, the Orchestration process will highlight which instrument may be missing in the second lab, which alternate Connection may need to be substituted, and how to re-create the process so that it is functionally equivalent.
CMOs—An Extension of the Lab
DLX facilitates easier work and transfer between an innovator lab and receiving lab such as a CMO, but the selection of CMO may be challenging. Previous specialized experience, which may be impossible to come by in some circumstances such as a public health emergency, is less important than rigorous oversight, meticulous technology transfer from innovator lab to receiving lab, and validation of process and technology on both sides. Most recently, this became evident in cases where CMOs were called on to respond to the COVID-19 pandemic in the global manufacture of vaccines. While it is entirely appropriate to place those CMOs under scrutiny and put them through a rigorous due diligence process, the “we’ve done it before” argument, which will inevitably be offered in the CMO’s proposal whenever possible, may offer less insight into the CMO’s qualifications than other factors, including:
- Pharma 4.0™ process and manufacturing approach
- Use of technology, people and process to affect the best possible outcome in technology transfer
- Transparency, communication, and data sharing
- Ability to replicate product testing processes (facilitated by Scitara DLX)
When selecting a CMO to manufacture a drug or vaccine, the technology transfer that takes place between the contractor and CMO, and how that transfer takes place, is of paramount importance, along with a high level of transparency and digital data connectivity. In the case of Scitara DLX, Orchestrations can be easily imported into a separate DLX instance on a separate tenant to facilitate the transfer between an innovator lab, and the receiving lab where the workflows of the innovator lab are replicated through the Orchestration export-import process, where both facilities are using DLX. This ability can decrease technology transfer time and minimize uncertainty.
Getting it Right the First Time
During the COVID-19 pandemic, the pharmaceutical industry, and vaccine makers in particular, have faced an unprecedented challenge. Those companies were tasked with developing, and then scaling up the manufacture of, a brand-new product with a global demand, during a pandemic marked by critical supply chain issues.
The technology transfer process, whether transferring between departments of a single organization or between an R&D organization in the US and a manufacturing facility in India, is inherently slow. It can be simplified, transfer can be accelerated and carried out with greater flexibility as well as accuracy with the help of Scitara DLX.
During the COVID-19 crisis, the need to develop and manufacture a vaccine in a hurry, and at an unfathomable scale, brought up some major supply chain challenges. The only effective way to roll out the vaccine on a global scale and achieve the desired “herd immunity” would be for the pharmaceutical companies that developed the vaccine, to partner with other pharmaceutical manufacturers around the world for production and distribution. The technology transfer itself is a process that would normally consume several months.
Scitara DLX Facilitates the Change
Technology transfer has always been a delicate operation, susceptible to numerous risks and complications. Digitalization and a high degree of automation is the next step.
By applying the advanced smart “Connect, Orchestrate, Monitor” technology in Scitara DLX, laboratories, R&D centers and their manufacturing partners can achieve near-universal connectivity for all measuring and test equipment. The Orchestrations built into the foundation of DLX automate and accelerate the technology transfer process with a rules-based system of automation and enforced processes to ensure that workflows can be automated in a reproducible manner, and compliance on the part of all partners, and an audit trail which achieves the ultimate goal of technology transfer. That goal is that the receiving facility is producing, with a high degree of confidence, equivalent product to that of the innovator lab and that there remains a smooth transfer and continuous synchronicity between the laboratory operations of all parties.