ARTICLES, CASE STUDIES, AND EDITORIALS
Global Biotech Selects Skyland PIMS® to Centralize and Streamline the Management of Batch Data, Process Specifications, and Control Limits.
A biotechnology company with a validated, innovative scientific platform manufactures a variety of generic drugs and focuses on developing novel therapeutics to treat rare, immune-mediated diseases. It has an extensive pipeline of drug candidates that target disease areas with significant unmet need in which the current standard of care falls short. Get Case Study
An Evolving Biopharma Streamlines the Management and Analysis of Critical Process and Batch Data Across a Diverse Product Portfolio and Complex Manufacturing Network using Skyland PIMS®
Through continued investment in an evolving R&D focus, a global biopharmaceutical company seeks solutions to rare and complex diseases for patients with limited or no options. The Company's approach has allowed it to shepherd new medicines to market – from late-stage discovery through clinical development and regulatory approval. GET CASE STUDY
Pioneer in CAR-T Technologies Centers Batch Data Management and Approvals Around Skyland PIMS®
A global leader in precision medicine is focused on developing CAR T cell therapies that offer cancer patients significant benefits over standard treatments. Operational Needs The cell therapy developer has an extensive pipeline of CAR T treatments with its lead program recently entering pivotal trials. It wanted to move off of Excel-based batch data management to a centralized database to accelerate process verification [...]
Analyze Raw Materials to Improve Product Quality
Analyze Raw Materials to Improve Product Quality Using software systems to understand raw materials impact on product outcomes Raw materials are intrinsic to the manufacturing process and quality of all bio/pharma products – small molecule pharmaceuticals, biologics, and cell and gene therapies alike. Even minor variations in raw materials such as media, excipients, and manufacturing process agents may cause process variability, and impact [...]
Having Confidence in your Data
Have Confidence in Your Data As Bio/Pharma Advances, So Must Our Data Integrity Bio/pharma development and manufacturing processes have been evolving at a rapid pace. The pharmaceutical industry has grown from simple aspirins to IV delivery, antibiotics and, most recently, cell and gene therapy. Products are more complex, tailored and varied than ever and the associated amount of data is growing - which [...]
Precision BioSciences Deploys Skyland PIMS®
Precision Biosciences Deploys Skyland PIMS Precision BioSciences (NASDAQ: DTIL) is a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies. With an eye towards therapeutic applications, the company’s ARCUS® genome editing platform has the potential to deliver safer, more specific genetic edits. ARCUS has a naturally occurring gene editing property that shuts itself off after making a highly [...]
Understanding Why Skyland PIMS® Was Selected – Novavax
Why Skyland PIMS was Selected - Novavax Headquartered in Gaithersburg, Maryland, Novavax is a late-stage biotechnology company that promotes improved global health through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company's vaccine candidates are genetically engineered using three-dimensional nanostructures of recombinant proteins critical to disease pathogenesis. ... Get the Full Case Study [...]
Optimizing Cell and Gene Therapy Processes & Accelerating Success
Optimizing Processes & Accelerating Success: In Cell and Gene Therapy Development and Manufacturing Cell and gene therapy companies are rapidly moving toward larger scale manufacturing operations. Their success is highly dependent upon optimizing processes to minimize the elapsed time between apheresis and the therapeutic injection. The goal of CAR T 2.0 and next generation TCR, TIL, and mRNA treatments is to elevate autologous [...]
Two Steps to Improve Chances of FDA Approval and Maximize Exit Valuations
Two Steps to Improve Chances of FDA Approval and Maximize Exit Valuations Very few promising life science discoveries actually result in an approved FDA product. But once your portfolio company clears significant discovery, safety and clinical milestones, there are a few straightforward steps they can take to improve the chances of regulatory approval and maximize their exit valuation down the line. These initiatives [...]
Maximize Exit Valuations and Mitigate Risks in Your BioPharma Portfolio
Maximize Exit Valuations and Mitigate Risks in Your BioPharma Portfolio R&D discoveries and clinical efficacy remain the key drivers of success in biopharma portfolios. But there are trends that are increasing the impact that manufacturing – and related data management – have on portfolio company valuation and liquidity options. The near universal reliance on contract manufacturers (CMOs) and the FDA’s focus on data [...]
Technology Transfer: Shifting the Paradigm to Dynamic and Persistent Process Knowledge Sharing
The goal of technology transfer is defined in ICH Q10 as “[the transfer of] product and process knowledge between development and manufacturing and within manufacturing sites to achieve product realization. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach and ongoing continual improvement.” Successful technology transfer is reliant on a few key variables including robust process characterization and communication [...]
