Life Science manufacturing data management has become increasingly difficult with advancements in complex biopharma and “precision” cell and gene therapies. Meanwhile, with performance metrics in manufacturing lagging behind those in other pharma operations, there’s a demand for accelerated tech transfer, FDA filings and commercialization. There are new business demands for information to be processed faster.
In the life science industry, like many sectors, Excel is a proverbial hammer. However, not all problems are nails. Launched by Microsoft in the 80s, Excel has become ubiquitous as a tool for every department and workflow imaginable, ad hoc analyses, back-of-the-envelope calculations and more.
Successful technology transfer is reliant on a few key variables including robust process characterization and communication and collaboration among multiple teams and sites. The key determinant to achieving success is the exchange of accurate, compliant data in relevant time.
Therapies are more complex, tailored and varied than ever and the associated amount of data is growing – which requires a new level of attention to detail.
IDBS will be presenting at the conference this year in Vienna. We look forward to being back at Bioprocess in-person events in 2022.
Skyland PIMS Democratizes Batch Data Management for AAV Gene Therapies and Accelerates CMO Collaboration
Leveraging multiple external partners, a leading clinical-stage biotechnology company manufactures AAV viral vectors as part of its proprietary gene delivery platform.
Gain key insights on the value of using purpose-built software systems to streamline your critical manufacturing data management and product quality processes across internal and external networks.
IDBS announces the latest release of its Skyland PIMS® software, which seamlessly combines product, process, and patient data across the biopharma life cycle and supply chain, providing insights that accelerate process understanding and ensure product quality.
The current state of biopharma drug development is a barrier to the timely and cost-effective treatment of disease.
Skyland PIMS version 4.2 introduces new capabilities to accelerate biopharma development and manufacturing by eliminating barriers to data and expanding statistical analysis to further enhance monitoring of processes across modalities, including cell and gene therapies, small molecule, and other biologics.