Newsletter | September 20, 2023

09.20.23 -- Takeda's Green Approach To IG Purification And Filling


4th Annual Biotech Startup Symposium

We invite you to the 4th Annual Biotech Startup Virtual Symposium (November 14th-15th), a free, two-day event to help biotech start-ups navigate their path to commercialization. This symposium will feature industry experts who will present and discuss various aspects of emerging technologies and the latest trends in their fields. Learn more.


Takeda’s Green Approach To IG Purification And Filling

To secure its spot as a 2023 ISPE Facility of the Year Awards winner, Takeda Lessines made some big moves, including building a wastewater treatment center on-site and installing 8,000 solar panels. This Q&A is part of a feature series on select FOYA winners.


Addressing Quality, Regulatory Concerns Before Pre-Approval Inspections

Learn about strategies to meet the quality and regulatory requirements of cell and gene therapies and how to identify issues early on, reduce quality and compliance risks, and avoid delays and rework.

Qualification Considerations For A “Factory-In-A-Box”

The cell therapy market is rapidly expanding into a multibillion-dollar industry, but its production is cost-prohibitive. Enter the "factory-in-a-box," which can be a game changer.

Bioinformatics: A Vital Precursor To Successful Biomanufacturing

Review a global approach to bioinformatics supported by four pillars: derivation of sequence-based features, building structural 3D models, exploring molecular flexibility, and analysis of the complex multi-dimensional data.

Manufacturing Cytotoxic And Noncytotoxic Drugs In A Multiproduct Facility

The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end user.

The Future Of Cell Therapy Manufacturing

Pressures surrounding the supply chain, cost, and foundational science that accompany cell therapy development have created new uncertainty and hampered investment.

Creating Accurate, Efficient, And Effective CDMO Project Proposals

To receive the most comprehensive project proposal possible, it is important to fill out any questionnaire as accurately and completely as possible.

Building More Resilient API Supply Chains

It is important to pursue a dualistic, longer term supply strategy that embraces cost control and supply reliability/diversity to improve the integrity and resilience of international supply chains.

Silkworm Larvae Plasma’s Use In The Pharmaceutical World

Learn about the potential of silkworm larvae plasma (SLP) including bacteria detection and identification and peptidoglycan detection.

Powerfully Simple Digital PCR

Evaluate the performance of an E. coli kit based on its detection sensitivity, quantification accuracy, and replicate uniformity as it performed when tested on a digital PCR system.

Immunoassays And Orthogonal Characterization

Learn about host cell proteins (HCPs), along with how they are produced, their negative effects, how to identify HCPs in drug substances, and some technologies offering solutions for manufacturers.

Achieve High Containment, Reduce Cross-Contamination Risk

Technology has evolved to make high-containment systems financially reasonable. Explore how single-use containment technology impacts capital spending and operating expenses.

Small Is Powerful And Sustained

Advances in sustained-release drug delivery could improve efficiency and consistency in drug release, manifesting real-life advantages for patients in the form of enhanced accessibility and compliance.

Achieving Agile, Expert Scale-Up With New Manufacturing Capacity

Finding a manufacturing partner with the capabilities and capacity to offer truly end-to-end development and scale-up can mean the difference between successful commercialization and the end of the road.

Feed Automation In Microbial Fermentation

Explore automating feeding based on the DO spike through the course of the bioprocess run and the benefits over manual processes.

Looking Both Ways For Your Small Biopharma Clients

Learn how a CDMO partner with deep technical and regulatory expertise and flexible support options is critical to advance your molecule toward commercialization with speed and reduced costs.

When To Outsource Protein Biologics Development And Manufacturing

Learn the elements and market factors impacting the make/build vs. buy decision, considerations to examine when evaluating options, and best practices for navigating this decision.

Inclusion Bodies: Mother Nature's Help Or Hindrance?

The pros and cons of soluble and insoluble processes: isolating, solubilizing, and properly refolding, and strategies to improve the performance of IB processes.

Add A 3rd Dimension To Your Immunoassay

If you are seeking protein size separation information in addition to immunodetection of protein target(s) of interest, these assays can provide more sensitive, accurate, and reproducible readouts than ELISA.

Biopharma Resilience: Addressing Manufacturing And Talent Needs

Learn how Lakes Bioscience and the National Horizon Centre are harnessing virtual reality for education and training and to get medicine to patients faster.

Critical Considerations For Improved Cryopreservation Of Cell Therapies

Explore critical considerations for optimizing cryopreservation that will help you to deliver program goals faster and ensure cell therapies are translated into consistent, potent, and accessible medicines.


Webinar: The Technology Debate — Single Use vs. Stainless Steel

The shift to single-use technologies has been ongoing for over a decade. Many are still anchored to stainless steel from their capital equipment investments, but is it holding them back? Join us October 4th as we will discuss the multipoint case for adopting single-use technologies throughout the workflow via an economic, operational, and environmental sustainability lens. Click here to learn more.


Optimize Your Chiral Separation And Chiral Purification

Serum-Free, Animal Component-Free, And Protein-Free Cold Storage Solution

Access cGMP Biomanufacturing Capacity Faster

SF-RVN Platform For Improving The Safety Profile Of Your Therapies


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