Newsletter | January 6, 2021

01.06.21 -- Moving Beyond Human Error In Biopharma Investigations And CAPA Programs

 
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Featured Editorial
Industry Insights
Leading The Edge Of Innovation Into Cell Culture Media Quality

In this white paper, we highlight the breadth of programs implemented across our organization to safeguard the quality of the cell culture media that are used in our customer processes.

Navigate The CMC Regulatory Landscape For Cell And Gene Therapies

The curing potential of cell and gene therapies is driving the industry to gain a better understanding of the evolving regulatory guidelines for these products, in order to bring them to market faster.

Cell-Based Potency Assay In Functional Characterization Of Therapeutic mAbs

Because characterization and comparison of originator and biosimilar candidate monoclonal antibodies (mAbs) is challenging due to their complex and variable structures, a range of analytical techniques should be employed.

Explore Alternative Analytical Methods To Solve Process Challenges

Successful and rapid analytical method development plays a key role in ensuring the development of robust processes to produce high-quality products. 

Application-Specific Enhancements To Single-Use Bioreactors

Product yield, production cost, and development timeline demands require perfusion, intensified fed-batch processes, and adherent cell culture solutions that address the specific needs of diverse bioproduction processes.

Aseptic Filling Operations: In-House Or Outsourced?

Pouring millions into the infrastructure and quality systems necessary to move away from manual filling is unrealistic and detracts from your strengths in drug development. 

Challenges And Solutions In Biologics Finished Product Manufacturing

While it's possible to develop a formulation that meets desired finished product characteristics in the lab, how do you ensure your formulation is practical for industrial-scale manufacturing?

Considerations For Your First Clinical Trial

It's important to understand that CROs do not typically manage the comprehensive clinical trial supply chain. This paper reviews seven clinical trial supply best practices to help ensure a successful trial.

Advantages Of Single-Layer Film vs. Multilayer Film In Bioprocessing

Speed and flexibility are critical to succeed in the bioprocessing market. Plastics technology enables small-batch, single-use packaging solutions for customized drugs to serve a smaller patient population.

Can You Afford Not To Outsource Buffer Preparation?

The decision whether or not to outsource buffer preparation is not clear-cut, but it provides an opportunity to balance risk with reward. This paper examines the benefits of outsourcing.

Automated High-Throughput mAb Purification Using Fibro Technology

Read how the Fibro PrismA unit provides a time advantage with comparable recovery and product quality attributes to resin-based columns.

Best Strategies To Accelerate Biologics Development And Commercialization

How a practical implementation of modernized cell line development workflow using high-yield cell lines and automated systems accelerates biologics development and commercialization.

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