Newsletter | February 20, 2025

02.20.25 -- Emerging Trends In mAbs Manufacturing In 2025 And Beyond

NEW PODCAST EPISODE

BoB@JPM: Ran Zheng, Landmark Bio

Ran Zhang was hire number one at Landmark Bio back in 2021. Today, she's CEO of the 70+ employee cell and gene therapy manufacturer. The Business of Biotech caught up with her at the JP Morgan Healthcare Conference in San Francisco for a discussion on Landmark's role in addressing the ATMP patient access and cost reduction challenges. Listen now and subscribe so you never miss an episode!

FOCUS ON MANUFACTURING CONTROLS

Emerging Trends In mAbs Manufacturing In 2025 And Beyond

Two key innovations — continuous perfusion in upstream processing and multicolumn chromatography in downstream processing — are having a profound impact on biologics manufacturing.

Bacteria Media Optimization Using In Silico Strategies

Determining ideal media composition for a bacteria is critical because it fosters a satisfactory grow rate, allowing the bacteria to reach the required growth yield.

Incremental Adoption Of A Modular Operations Platform

By 2027, biologics is expected to grow by $120 billion. With TrackWise Manufacturing, you can combat the ever-growing biologics market. Find out more about the platform here.

Maximizing ROI In Pharma: Extracting Value From Analysis And Reporting

Explore strategies for maximizing ROI in pharma through advanced analytics, streamlined operations and an interconnected data management platform.

Digital Transformation - The Power Of Your Data

Discover how you can circumvent numerous recirculations during the ultrafiltration process step, boost downstream bioprocess yield, and identify and resolve process inefficiencies.

The Problem With Construction Quality

Data center construction quality management is inadequate, with issues traced to human error. A stronger focus on quality control and assurance is needed for success.

5 Areas To Focus Your QRM Strategy For Sterile Drug Products

Explore five areas that can form part of a quality risk management strategy to ensure the compliant manufacturing of sterile drug products.

First-Pass Yield

Learn how a life sciences manufacturer generated a contextualized data set that eliminated the manual effort required to curate production data and improved their process in real time.

Revolutionizing Bioanalysis: Harnessing AI For Enhanced Precision, Insights, And Efficiency

Can AI predict immunotherapy success earlier than traditional methods? Experts reveal data-backed applications in this enlightening session.

Demolishing Doubts About AI In Pharma

The FDA and PDA's recent initiatives provide frameworks and guidance for integrating AI into pharmaceutical manufacturing, emphasizing innovation, and safety.

MANUFACTURING CONTROLS SOLUTIONS

TrackWise Manufacturing For Life Sciences - Honeywell Life Sciences

ETQ Reliance: The Leading Electronic Quality Management System (eQMS) - ETQ

A Leading Digital Validation Platform For Life Sciences - Kneat Solutions

Introducing eve: The Bioprocess Platform Software - INFORS HT

FOCUS ON FACILITIES DESIGN & MAINTENANCE

Aseptic Environmental Monitoring For Vaccine Manufacturing

To meet immediate vaccine demand, aseptic manufacturing capacity must increase quickly. This means environmental monitoring programs must adapt rapidly as well. Thoughtful planning can help.

Increasing Manufacturing Workspace Efficiency In Biopharma

Surplus and idle equipment can lead to decreases in workspace and work efficiencies for a manufacturing site. Learn how you can get paid for them and clean up your workspaces.

Prioritize Cleaning & Disinfection During Facilities Design

Thorough consideration of cleaning/disinfection during facility design eases maintenance across the facility lifecycle, optimizes workspace utility, and contributes to efficient facility operation.

Ask The Expert: Single-Use Technology In Cell And Gene Therapies

As CGT developers gain knowledge about their processes, single-use technologies (SUT) manufacturers can better address the sector's unique autologous needs by adapting to smaller volume production.

Product D-Value Studies: A Critical Tool In Sterilization Process Development

Learn about what questions to ask when developing a sterilization method and a critical tool that can help guide your decisions.

Airflow Visualization Studies: The Impact Of Annex 1 On Sterility Assurance

Techniques like Smoke Studies and CFD analyses are crucial for contamination control, aiding cleanroom qualification, environmental monitoring, and optimizing contamination control strategies under Annex 1.

How To Identify Optimal Materials For Biopharma Single-Use Solutions

Have you thought about how the materials chosen for the tubing, transfer sets, single-use bags, and manifolds in therapy manufacturing could enhance your processes?

FACILITIES DESIGN & MAINTENANCE SOLUTIONS

Cleaning Hormone Residues - Alconox Inc.

RoSS.KSET: Protection For Different Single Use-Bags - Single Use Support

Lancer Ultima Labware Washing Systems - Getinge

Single-Use Flexible Freeze Containers For Bulk Drug Substance - W.L. Gore & Associates

The Advantages Of Creating A Workflow When Monitoring A Cleanroom - TSI Incorporated

Welders And Sealers That Deliver Dependable, Sterile Results - Terumo BCT

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