White Papers
Tech Transfer Success Factors
Tech transfers play a vital role in ensuring that medicines reach patients on time. This article looks at the steps involved in tech transfers and the key factors that help biotechs succeed in their biologics transfer projects.
Early Solid Form Screening to Guide Drug Substance Through Drug Product Development
Solid form screening (SFS) encompasses the search, preparation, and characterization necessary to identify, isolate, and ensure confidence in the stability and downstream manufacturability of a lead form. In many ways, this process serves as the bridge between drug substance and drug product for new chemical entities.
Smart Manufacturing and Beyond: The Tri-Integrity Approach and Its Support for Quality Management Maturity in Industry 4.0
Discover how the Tri-Integrity approach is transforming modern manufacturing into a connected, intelligent, and quality-driven ecosystem.
Empower Your ADC Drug Product Tech Transfer
This white paper provides a comprehensive overview of the challenges and solutions associated with technology transfer for antibody-drug conjugate (ADC) drug product manufacturing.
Updated requirements on balances for the pharmaceutical industry: Current status from USP, Ph.Eur., JP, ChP
This white paper summarizes what has changed with the latest revisions in the major global standards,United States Pharmacopeia (USP), European Pharmacopoeia (Ph.Eur.), Japanese Pharmacopoeia (JP), and Chinese Pharmacopoeia (ChP).
Strengthen Container Closure Integrity Across the Drug Product Lifecycle
Maintaining container closure integrity (CCI) is essential to ensure the safety, quality, and efficacy of sterile drug products.
Accelerate Tox Material Delivery and Stay on Track for IND Submission
As development timelines tighten, generating toxicology (tox) data quickly has become a critical milestone on the path to IND submission.
Discover how Lab Virtual Assistants (LVA) powered by mcube™ are transforming research, development, and manufacturing labs into intelligent, self-optimizing environments.
Modern life-science labs are under growing pressure to accelerate research, scale efficiently, and maintain quality — but traditional manual workflows can’t keep up.
Quantifying the ROI of Integrated CDMO-CRO Models in Drug Development
As development costs climb and project timelines grow tighter, the traditional outsourcing model is showing its limitations. Fragmented coordination between CDMOs, CROs, and clinical supply vendors often leads to delays, inefficiencies, and lost opportunities.
Ultimate Guide to Pharmaceutical Quality Management
The guide highlights the essential shift in pharmaceutical quality management from document-centric to data-centric approaches, driven by the need to overcome unstructured data and siloed processes in a complex regulatory environment.
