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Quality by Design (QbD)

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Achieving Scalable and Sustainable Precision Fermentation Using Process Analytical Technology
Fermentation

Achieving Scalable and Sustainable Precision Fermentation Using Process Analytical Technology

Charlotte Hughes, Ph.D.

Hamilton

PAO-02-25-CL-18Feb 27, 2025
Ensuring Biologic Stability with Tailored and Cutting-Edge Lyophilization Solutions
Lyophilization

Ensuring Biologic Stability with Tailored and Cutting-Edge Lyophilization Solutions

Brecht Vanbillemont, Dr.; Lisa Besslich, Dr. Rer. Nat.

Coriolis Pharma

PAO-02-25-CL-12Feb 18, 2025
Designing Quality into Biomanufacturing
QbD

Designing Quality into Biomanufacturing

Miguel Carrion; Michelle Kneeland

Tanvex CDMO

PAO-10-24-CL-09Oct 29, 2024
Assessing Developability and Designing Advanceable Formulations from the Start
Developability

Assessing Developability and Designing Advanceable Formulations from the Start

Nazar Elkarim, Ph.D.

Mikart

PAO-09-24-CL-02Aug 26, 2024
Small Molecule API Discovery and Development Trends
Nice Insight API Report

Small Molecule API Discovery and Development Trends

April Stanley, MS MBA

Nice Insight

PAO-03-24-NI-01Mar 21, 2024
Managing Risk in Cutting-Edge mRNA Therapeutics
Risk Management in mRNA Manufacture

Managing Risk in Cutting-Edge mRNA Therapeutics

Jessica Madigan; Normand Blais

BIOVECTRA

PAO-07-23-CL-04Jul 31, 2023
A Concerted QbD Approach to Development and Manufacturing of Nucleic Acid Therapies
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

PAO-11-022-CL-06Jan 10, 2023
Quality in Equals Quality Out in mRNA Manufacturing
Quality in mRNA Manufacturing

Quality in Equals Quality Out in mRNA Manufacturing

Judith McCorry

Vernal Biosciences

PAO-10-022-CL-08Nov 08, 2022
Raman Spectroscopy as a PAT Tool Advancing Biopharma Manufacturing
Real-Time Monitoring

Raman Spectroscopy as a PAT Tool Advancing Biopharma Manufacturing

Stacy Shollenberger

MilliporeSigma

PAO-09-022-CL-08Sep 30, 2022
Approaching Viral Vector Manufacturing With an Emphasis on Quality and Design
Viral Vector Manufacturing

Approaching Viral Vector Manufacturing With an Emphasis on Quality and Design

Chris Berger; Atef Khezri

Avid Bioservices

PAO-05-022-CL-02May 10, 2022
Streamlining Highly Potent Drug Commercialization
High Potency

Streamlining Highly Potent Drug Commercialization

Norbert Straub; Uwe Korn; Robert Klehr

Fareva

PAO-04-21-CL-04Apr 19, 2021
Innovative Approach to Process Development
Process Development

Innovative Approach to Process Development

Gerhard Noessner, Ph.D.

Fareva

PAO-02-21-CL-02Feb 03, 2021
Allogeneic T Cell Therapies: Efficient Commercial Manufacturing Readiness using “Manufacturing by Design” Methodology
Cell Therapy

Allogeneic T Cell Therapies: Efficient Commercial Manufacturing Readiness using “Manufacturing by Design” Methodology

Catalent

PAO-12-20-CL-01Dec 16, 2020
Preparing for the ADC Explosion with End-to-End Support
Antibody–Drug Conjugates

Preparing for the ADC Explosion with End-to-End Support

Jyothi Swamy, Ph.D.; Elizabeth McKee

MilliporeSigma

PAP-Q4-20-CL-014Dec 09, 2020
Positioning a CDMO to Meet Future Needs
CDMO

Positioning a CDMO to Meet Future Needs

Tyler Kerr; James Balog; Andrew Waaso

Albemarle Fine Chemistry Services

PAP-Q2-20-CL-006Jul 01, 2020
The Ideal Capsule Supplier: Using A Holistic Approach to Facilitate Customer Success

The Ideal Capsule Supplier: Using A Holistic Approach to Facilitate Customer Success

Jonathan Gilinski

CapsCanada

PA2914Mar 12, 2019
Speeding Development and Reducing Costs with Analytical Quality by Design
Quality by Design

Speeding Development and Reducing Costs with Analytical Quality by Design

António Ramos; Rui Loureiro

Hovione

PAP-Q2-17-CL-006Jun 05, 2017
Building a One-Stop Shop CDMO for Biopharmaceuticals
CDMO

Building a One-Stop Shop CDMO for Biopharmaceuticals

Federico Pollano

Rentschler Biopharma SE

PAP-Q2-17-CL-012Jun 05, 2017
Designing a Better Single-Use Facility

Designing a Better Single-Use Facility

Carl Carlson

Exyte

PAP-Q1-17-CL-012Mar 08, 2017
Harnessing CDMO Expertise for Fill-Finish and Inspection of Sterile Pharmaceuticals
Fill-Finish

Harnessing CDMO Expertise for Fill-Finish and Inspection of Sterile Pharmaceuticals

Philippe Mougin, Ph.D.

Cenexi

PAP-Q03-16-CL-015Aug 01, 2016
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