QbD

Designing Quality into Biomanufacturing

Miguel Carrion; Michelle Kneeland

Tanvex CDMO

Developability

Assessing Developability and Designing Advanceable Formulations from the Start

Nazar Elkarim, Ph.D.

Mikart

Sequence Variants

Accelerating Protein Sequence Variant Analysis

Kyoungmin Lee; Yunjeong Heo; Jongbae Park

Samsung Biologics

pDNA Manufacturing

Overcoming pDNA Supply Challenges for mRNA Manufacturing

Mack Kuo, Ph.D.

Nice Insight API Report

Small Molecule API Discovery and Development Trends

April Stanley, MS MBA

Nice Insight

Viral Vectors

A Viral Vector CDMO Vision that Resonates

Drew Brennan; Chris Berger; Elie Hanania, Ph.D.; Dave Ingamells; Rami Barghout, PE

Avid Bioservices

Accelerating Product Development

What strategies are being employed to accelerate product development and commercialization without compromising quality?

Pharma's Almanac

Nitrosamine Impurities

Addressing the Evolving Nitrosamine Contamination Issue

Olon

Risk Management in mRNA Manufacture

Managing Risk in Cutting-Edge mRNA Therapeutics

Jessica Madigan; Normand Blais

BIOVECTRA

Quality Culture

Does Your Biologics CDMO Truly Have a Culture of Quality?

Joe Payne

Scorpius BioManufacturing

Lipid Nanoparticles

Facilitating Lipid Nanoparticle Production with a Unique Continuous Manufacturing Solution

Antonio Costa, Ph.D.; William Pasek

DIANT Pharma

Viral Vector Manufacturing

Considerations in Viral Vector Analytical Development to Enable Smooth Transfer to Quality Control

Chris Berger; Kilian Witzel

Avid Bioservices

Quality by Design

A Concerted QbD Approach to Development and Manufacturing of Nucleic Acid Therapies

Lynda Menard, Ph.D.; Grant Henderson, Ph.D.

Vernal Biosciences

PLIs

A Strategic Approach to Pre-License Inspections

William Leonardi, Ph.D.

Avid Bioservices

Robotic Sterile Fill-Finish

Accelerating Drug Development Using Robotic Sterile Fill-Finish Platforms

Jeff Clement; Mark Shepanski

PCI Pharma Services

Quality in mRNA Manufacturing

Quality in Equals Quality Out in mRNA Manufacturing

Judith McCorry

Vernal Biosciences

Real-Time Monitoring

Raman Spectroscopy as a PAT Tool Advancing Biopharma Manufacturing

Stacy Shollenberger

MilliporeSigma