Newsletter | April 12, 2021

04.12.21 -- Medicare Braces For Expanded Use Of High-Cost CAR T-Cell Therapy

Featured Editorial
Industry Insights
Cut It Out: The Role Of Gene-Editing Technologies In Combating HIV

Despite the public attention and large population impacted by HIV, developing a cure has been particularly difficult. Will gene-editing techniques, such as the CRISPR-Cas9 system, change the paradigm?

How Oral Solid Coating Technologies Can Enhance Delivery Strategy
Oral solid dose (OSD) remains a dominant form in drug delivery and development. Discover advances that improve oral solid stability and integrity through technology platforms and coating technologies.
Optimizing Filling Technology To Minimize API Loss

New advances in filling technology offer solutions that can minimize lost API and eliminate sources of risk while still meeting the regulatory requirements for testing and quality assurance.

Improve Bioprocessing Efficiency With A Standardized Automation Platform

Designed specifically for the biomanufacturing industry, Cytiva's Figurate automation is a portfolio of automation platform solutions powered by the reliability of Emerson’s DeltaV.

Keys To Successful Risk Management In Clinical Trials

Effective risk management recognizes variables unique to each clinical trial while embracing consistent documentation practices, stakeholder responsibility, and best practices informed by experience.

Align Your Chemistry, Manufacturing, And Controls (CMC) Strategy With Clinical Path Requirements And Timelines

Manufacturers must understand the challenges associated with creating a chemistry, manufacturing, and controls (CMC) strategy in today’s crowded and diverse market and the expertise and resources needed to successfully execute it.

How Supplier Evaluations, Component Neutrality Enhance Supply Chains

When a new product, technology, or supplier is selected during the development and design phase of the biological manufacturing process, manufacturers must assess the supplier’s own supply chain and beyond.

Intensified Buffer Management For Manufacturing Efficiency, Reduced Cost

This white paper describes a novel, integrated approach to intensified buffer preparation and how this strategy can increase process flexibility and efficiency, and reduce costs.

High Yield Protein Production System For Suspension CHO Cells

Attributes of the new and improved CHOgro® High Yield Expression System help researchers obtain gram quantities of protein, simplify workflows, and shorten development pipelines.

A Rapid Alternative To Culture-Based Mycoplasma Detection

Mycoplasma contamination represents a serious, costly problem for biomedical research labs and facilities involved in development and manufacture of cell-derived biological and pharmaceutical products.

It Depends: The Real Answer To The Single-Use Or Stainless-Steel Question

There have been innumerable and contentious arguments over stainless vs. single-use biomanufacturing systems. The reality? They can coexist in hybrid bioprocessing manufacturing environments.

A GMP Strategy For ADC Synthesis Using Site-Specific Chemical Conjugation

Learn about the establishment and application of a GMP strategy for site-specific antibody-drug conjugate (ADC) production using AJICAP technology, a chemical conjugation platform that employs IgG Fc-affinity peptides.

From Molecule To Medicine. Delivered.

To be able to meet the growing needs of patients around the world, a company must have a strategy that can shepherd new biologics therapies throughout the development timeline.

Data Integrity And Compliance: What Every Lab Should Know

While FDA 21 CFR Part 11 allows life sciences organizations to use e-records in place of paper, a piece of software by itself cannot be compliant. Here's how to develop and perform GMP validation.

Biologics Drug Product: Formulation, Tech Transfer, Delivery Strategies

This webinar covers the key considerations for formulation screening of therapeutic proteins with a focus on maintaining protein stability and avoiding aggregation.

The Right Transfer Solution For Media And Buffer Powders

The webinar will present best-in-class solutions to streamline the transfer process, resulting in more accurate and faster production and improved batch cycle times.

Accelerate Biopharma Development In The Digital Age

This webinar tackles the key COVID-19-related disruptions affecting manufacturing, data management, and R&D in the lab, and how digital technology investments impact drug discovery and marketability.

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