Newsletter | December 6, 2024

12.06.24 -- CMC Strategies With CDMOs: Ensuring CQAs For Oligos And Peptides

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Let Us Handle Your Buffer Preparation

Thermo Fisher Scientific is here to support you with the buffer preparation in your manufacturing workflow. Leaving the non-core activities to us enables you to focus on the patient therapy development. Our capabilities cover off-the-shelf products like WFI, NaOH, NaCl, or EtOH, a library of the most frequently used buffers that are made-to-order, as well as fully customized buffers.

FOCUS ON QUALITY/ANALYTICAL METHODS

CMC Strategies With CDMOs: Ensuring CQAs For Oligos And Peptides

Developing a practical chemistry, manufacturing, and controls (CMC) strategy for oligonucleotides and peptides demands a shift in approach in terms of the way you collaborate with your CDMO.

Antibody Coverage Analysis Of E. coli HCPs In The BL21(DE3) Strain

Review a study conducted to determine the suitability and similarity of Cygnus E. coli HCP ELISA Kits to quantify BL21(DE3) Host Cell Proteins (HCPs).

Organ-Chips Show Superior Performance To Animal Models, Spheroids

Examine how 780 human Liver-Chips were assessed for their ability to predict drug-induced liver injury from small molecules.

Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence?

Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.

Flow Cytometry Workflow Journey

You have designed your flow cytometry panel for cell manufacturing and patient monitoring. Now what? Use this journey map to help ensure optimal resolution of your populations of interest.

Assessing A Targeted Molecular Method For Adventitious Virus Detection

Discover a CHO AOF panel that provides rapid detection of relevant adventitious viral contaminants in bulk harvest material, and explore data showing equivalent sensitivity to the in vitro assay.

The Need For Mass Produced Spheroids

Researchers looking for reliable ways to recapitulate physiological conditions are turning to spheroids and other 3D objects, seeking ways to mass-produce 3D models for various applications.

Multiplexed And Quantitative Assays For Enhancing Antibody Discovery

Maximize the efficiency of your multiplex assays: Discover optimal antigen labeling techniques and strategies for executing 16 multiplexed functional assays with consistent, reliable results.

Particle Investigation: Going One Step Further Than Just The Identification

Discover examples of visible particle identification and the root cause investigation, along with a discussion of the performance of additional troubleshooting using advanced and innovative technologies.

QUALITY/ANALYTICAL METHODS SOLUTIONS

Analytical & Quality Control - EirGenix Inc.

A Human-Relevant Liver Model With Minimal Drug Absorption - Emulate

Thermal Analyzers For The Most Demanding Biopharma Applications - TA Instruments

FOCUS ON REGULATORY

Biopolitics With Allan Shaw

The notion that political influence has no place in biology appears poised for a test it hasn’t studied for. Trump administration nominations, from RFK, Jr. to HHS and Vivek Ramaswamy to the newly-proposed DOGE, are driving speculation over the implications for biotech and other life sciences industries. How should biotech builders be obviating? On the Business of Biotech, we’re joined for some reflection by none other than Allan Shaw.

Understanding FDA Recall Risks And Solutions For Manufacturers

Investigate the factors contributing to FDA recalls, the effects on both consumers and businesses, and how integrated digital solutions can play a crucial role in preventing such incidents.

Leveraging Bio-Functional Assays For Charged Variants Characterization

The heterogeneity of a biologic product has implications for the final therapy's safety and efficacy. Explore challenges associated with charged variants, including mAbs and fusion proteins.

When Should Filter Validation Be Performed?

Learn about a program that has been developed to facilitate risk mitigation before process-specific filter validation is performed.

Measuring Cleanliness

Learn about methods of detecting and measuring cleanliness in relation to soil quantities.

Welcoming The "Era Of ADCs"

Dr. Loretta Itri sat down to explore the promise of TRODELVY® and other antibody-drug conjugates as transformative treatments for a range of malignancies and intractable diseases.

REGULATORY SOLUTIONS

Jubilant HollisterStier Capabilities And Services - Jubilant HollisterStier

Biological Indicator Testing: Meeting Regulatory Demands With Confidence - Mesa Laboratories

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