Whitepapers

In this industry brief, we examine key challenges that exist in the biopharma industry, particularly in the early phases of commercialization, and review ways organizations can address them.  

Moving a biopharmaceutical product from molecule-to-market is demanding in terms of expertise and capabilities needed throughout the development and manufacturing process. In this white paper, we explore the processes, operations, and customer-focused approach of Emergent CDMO's integrated internal teams, providing efficient organization alongside smooth and timely technology transfer and scale-up, from R&D to GMP manufacturing. Download our latest white paper to learn how partnering with an integrated CDMO can help create an efficient development services framework to achieve your drug substance and drug product manufacturing goals.

This article presents a detailed mapping of processes and data flow to identify the gaps associated to Data Integrity for GxP processes managed by computerized system and/or manually.

Understand the role proper wiping technique plays in relaiable and consistent contamination control. Review the right way to quarterfold a wipe as well as the correct technique when wiping a surface to ensure contamination removal.

Patient recruitment, retention, diversity, & safety are all factors driving the need for radical innovation in clinical research. This need was made painfully apparent during the current COVID-19 pandemic. We can no longer ‘do the same thing and expect a different result’; it’s time to take giant steps forward. Find out how Medable, the recognized industry leaders in Decentralized Clinical trials, can partner with your organization to digitally transform your clinical protocols. Your research teams can experience benefits such as; improved patient experience, higher quality outcomes data, & savings of US$25,000,000+ for individual studies. Download the White Paper now.

Over 70% of potential research participants live >2 hours away from a research site, & patient drop-out rates can reach 30% depending on the therapeutic area. The Solution: Medable eConsent Why? 1. Medable eConsent enables the enrollment of underrepresented, diverse populations through remote consenting. 2. Medable eConsent has proven to reduce screening timelines by 50%, & increase patient engagement by 15%+.

A recent study by Morning Consult finds that >54% of US adults would be willing to participate in a clinical trial if it had a 30-minute-or-less commute. This is quite striking, given that <4% of the 328 million people in America are actively participating in clinical research today. The solution? - An accessible, intuitive digital clinical platform that connects sponsors, sites & patients, and replaces burdensome paper forms and physical visits with electronic consents (eConsent), electronic Clinical Outcome Assessments (eCOA’s), and remote visits (TeleVisits). Find out how Medable, the recognized industry leaders in Decentralized Clinical trials, can partner with your organization to digitally transform your clinical protocols. Your research teams can experience benefits such as; improved patient experience, higher quality outcomes data, & savings of US$25,000,000+ for individual studies. Download the White Paper now to learn how.

The inVia™ Qontor® microscope's optical tweezing performance depends on the optical properties of the particles and the medium. Typically, it can trap particles smaller than 10 ?m.

View a short podcast with Eurofins BioPharma Product Testing to learn how Eurofins overcomes the challenges faced in sterile fill finish manufacturing in the bio/pharmaceutical industry and solutions for producing small batches of sterile GMP or GLP products for use in Toxicology Studies, as well as Phase I or Phase II clinical trials by eliminating human error and other associated risks.

This paper explores raw material, formulation, process, and equipment design factors that potentially contribute to unexpected early API release from Wurster coated enteric particles.

CPI, a CDMO specializing in Wurster fluid bed coating, has designed and optimized equipment based on linear scaling principles, creating ease and predictability to scale-up.

Antibodies and proteins are critical reagents with wide application in in vitro diagnostic developments, companion diagnostic and biomarker assays. Depending on final application, different quality standards may apply, from research use to full GMP production. Learn more about Curia’s GMP Production of antibodies & proteins for critical assays and diagnostic applications.