White Papers

Buffers and process liquids for biopharmaceutical production

The global biopharmaceutical market is rapidly growing, with small and midsize organizations outpacing large organizations in market share growth.

Revolutionize Biomanufacturing with Advanced Process Liquid Outsourcing

In the dynamic world of biopharmaceuticals, the demand for innovative and efficient manufacturing processes is higher than ever.

QualTrak™™ qPCR & dPCR Biopharma Ecosystem

Accelerate the development and manufacturing of mRNA and protein-based vaccines by leveraging Applied Biosystems QualTrak real-time PCR and digital PCR tools for biopharma. Incorporate these highly-sensitive and accurate technologies into workflows across your pipeline for applications in gene expression, genotyping, contaminant testing, and more.

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.