Newsletter | January 17, 2024

01.17.24 -- Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs

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Importance Of High-Performance Cell Culture Media And Feeds: An Industry Perspective

Cell culture media and feeds play a central role in determining both process productivity and product quality. Developing the right formulations, however, can present several challenges, particularly for newer modalities. This Q&A features a panel of experts addressing current development challenges, potential solutions, and benefits gained through cell culture media and feeds optimized for an individual cell line and process.

FEATURED EDITORIAL

Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs

Appropriate manufacturing and timely delivery of investigational products are essential for the successful execution of clinical trials. This article shares best practices working with CDMOs as well as phase-appropriate GMPs of the clinical supply.

INDUSTRY INSIGHTS

Welcoming The “Era Of ADCs”

In an episode of the Business of Biotech podcast, Dr. Loretta Itri sat down to explore antibody-drug conjugates as transformative treatments for a range of intractable diseases.

Optimizing Chromatography Media In Bioprocessing

How can you optimize your media for chromatography and improve consistency, yield, and purity through the integration of automation technologies such as advanced slurry preparation systems?

Osmolality Monitoring For UF/DF And CEX Capture Of mAbs

The goal of this study was to understand the impact of monitoring osmolality during an Ultrafiltration/Diafiltration (UF/DF) step prior to CEX capture of the monoclonal antibody Rituximab.

MAM For Biopharmaceutical Analysis

This notebook from the Biopharmaceutical Scientific Operations Team at Waters illustrates key attribute monitoring workflows to improve and streamline MAM analysis of biotherapeutic proteins.

Transitioning From Gel Clot To Kinetic Testing

Learn why endotoxin testing has become integral to the development and quality control of injectable pharmaceuticals and medical devices and the development and advantages of kinetic LAL assays.

7 Trends In Global Vaccine Development 2024

As novel methods for vaccine development grow more important, global vaccine development trends are emerging in a way that could impact the vaccine market in 2024 and beyond.

Harnessing New Tech For Next-Generation GS-CHO Expression Solutions

What makes a next-generation CHO bioproduction process? Take a journey through areas of innovation for creating expression systems of the future, with a focus on DNA and cell expression technologies.

Calculating Your Business Case For Continuous Manufacturing

Review key considerations as a Pharmatech Associates expert introduces a useful financial equation to calculate amortization to develop the business case for PCM and provides a few real-world cases.

Turbulent Mixing: Scaling Up Nanoparticle Manufacturing For The Future

Choosing between turbulent and microfluidic mixing methods in your lipid nanoparticle (LNP) production can have a significant impact when scaling up production.

Custom Formulation Solution Including An Animal-Origin Element

Explore the customized, multicomponent solution designed to meet quality and packaging specifications, while including an animal-origin element, as well as a non-compendial component.

Post-Discovery Priorities: Streamlining Your Molecule’s Route To IND

Four experts in post-discovery strategy share insights into methodologies, robust platform process design, high-throughput automation technologies, optimized workflows, and life cycle approaches.

High-Throughput Developability Assessment Enables Efficient Formulation

The biopharmaceutical industry is focused on maximizing the effectiveness of early-stage candidate assessments to predict a molecule’s chances of success before investing heavily in that molecule.

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2024 PDA Annual Meeting

The 2024 PDA Annual Meeting promises to be nothing short of epic! Get ready for plenary speakers who will ignite your imagination, technical presentations, and high-energy roundtable discussions to keep you at the top of the industry, and networking opportunities to connect you with the best minds in pharma! Top that off with industry site visits and fun and engaging social activities! Register now.

SOLUTIONS

The Way Forward In Mycoplasma Detection

Bioprocessing Fluid Transfer Sets

3D Bioprocess Assemblies

Leveraging Expertise For Plasmid Production Success

Pharmaceutical Program And Project Management Services

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In a period marked by resource constraints, focusing R&D on the most likely molecules to succeed is paramount. But how do you do it? Don’t miss our first Bioprocess Online Live of 2024 as we explore the most efficient approaches to scalable discovery, molecular screening and assays, definition of CQAs, establishing a proof of concept, and assessing developability. Registration is free for this January 23rd event.

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