Newsletter | April 27, 2021

04.27.21 -- ATMPs & Manufacturing Therapeutics In Hospitals

 
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Industry Insights
High Purity Of Amino Acids: Foundation Of Reliable Media Performance

Amino acids used in biopharma processes must be animal-origin free, governed by strict change control policies, and must utilize precise processes to eliminate endotoxins and heavy metals.

The Source Of GMP-Source: How Client Demand Drives Innovation
GMP-Source, which is a term we coined, serves the purpose of a highly qualified raw material for a generation of virus, messenger RNA template, and transgenic expression of proteins.
5 Reasons To Consider APAC For Clinical Trials

Small and midsize biopharma companies in the U.S. and Europe are under intense pressure to find more efficient and cost-effective ways to commercialize their products. In an increasingly competitive clinical trial environment, sponsors have begun to shift their focus to the Asia-Pacific (APAC) region for their studies. Here are five reasons why the APAC region may be a good fit for your global clinical trial.

A Tale Of Two CDMOs: Which Choice Will Your Biopharma Make?

Today’s growing biologics challenges make the choice of a CDMO critical. You need a trusted and experienced partner from DNA sequence to commercial launch and at each checkpoint along the way.

Growing Your Biopharma: Ten Questions You’re Likely To Face From Investors — And How To Respond To Them

There are many important considerations to address in building your new drug program. One of the most critical is funding to get you to your next milestone. In this guide, investment veterans and biopharma executives were asked which questions they often ask (and have been asked). Answer these questions well and your potential investors are that much more likely to support your company’s vision.

Developing Advanced Therapies: Considerations For Internal Versus External Manufacturing

Due to their complexity and cost, developers of cell and gene therapies face unique manufacturing hurdles. Determining the right approach to manufacturing is crucial when bringing these advanced therapeutics from the clinic to commercialization. This paper provides a distinct perspective on how to approach manufacturing and other roadblocks at every stage of development.

Adenovirus Production In Single-Use Xcellerex XDR-10 Bioreactor System

This application note describes the production of adenovirus in HEK293 cells cultured in HyClone CDM4HEK293 culture medium.

Multidimensional Analysis Of T-Cell Cytotoxicity And Serial Killing

To harness their full therapeutic potential, we must understand the relationship between target cell killing and other critical functions of individual T cells. This application note demonstrates how the Berkeley Lights platform can be used to interrogate antigen-specific serial killing activity of single CAR T cells and correlate this to cytokine secretion and proliferation while preserving individual T cells for downstream analyses or expansion.

Collaborative Relationship Allows Avectas To Accelerate The Translation Of SOLUPORE Into The Clinic

Avectas, a cell engineering company, was preparing its nonviral cell engineering solution technology for commercialization and required its platform to be assessed by an experienced third party. They requested support from CCRM, a Canadian center of excellence in cell and gene therapy and a reliable partner to extend their development capacity and capabilities.

Outsourcing Trusted-Weight Dry Powder Chemicals To Support Expansion

The gene therapy division of a major pharmaceutical manufacturer was looking for ways to overcome capacity constraints due to the increased production demands for process liquids and buffers. Read how the customer benefited from the procurement of larger lot sizes that were not capable of being handled within their facility, resulting in annual savings for raw materials and QC testing.

Can Innovation Drive Down Cell Therapy Manufacturing Costs?

The high cost of producing new cell and gene therapies is one of the largest issues facing the industry. After launching Kymriah and Yescarta, Novartis’s price tags were $475,000 and $375,000, respectively. Advancements in manufacturing are driving costs down, but not at the required pace.

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