Newsletter | January 8, 2020

01.08.20 -- Design Of Experiments 101: Understanding DOE's Foundational Elements

Featured Editorial
Design Of Experiments 101: Understanding DOE’s Foundational Elements
By Mark Durivage, Quality Systems Compliance LLC

DOE (design of experiments) is a very powerful tool that can be used to characterize a process. This article discusses several types of experiments, as well as the basic statistical tools and techniques, that can be used when performing a DOE.

Biosimilars: Lessons Learned From Regulatory Approvals
By Sarfaraz K. Niazi, Ph.D., and Sunitha Lokesh

This article, based on the EMA’s European public assessment reports (EPARs) and the FDA’s biologics license application (BLA) reviews identifies many inconsistencies that require revision of regulatory guidance to assure faster approval of biosimilars.

Industry Insights
Incorporate Data Integrity Into Your Pharma Quality Management System
Article | By Anthony Warchut, PAREXEL

A viable quality management system (QMS) cannot be based upon anything except data and records that are attributable, legible, contemporaneous, original, accurate, complete, and easily retrievable.

Quality Assurance And Your CDMO
Article | By Chantale G. Robles, Grifols Recombinant Protein CDMO Services

The result of regulatory compliance with quality standards is binary, but the processes employed to get there don't need to be rigid, inefficient, and expensive. Learn how innovation drives efficiencies.

What Makes It So Hard To Select A CMO?
Article | By Kate Hammeke, ISR Reports

Learn the unexpected findings from the Industry Standard Research Outsourcing Models survey from the perspective of a market researcher.

Is Your CMO Ready For Serialization And Aggregation?
White Paper | By Lloyd Mager, AbbVie

While some are waiting for mandates for traceability, serialization, and aggregation, others are recognizing the inevitability of these strategies. Does your CMO have a dedicated traceability operation in place?

Scalable Freeze And Thaw Platform For Pharmaceutical Bulk Drug Substance
Application Note | By Daniel Nägeli, Single Use Support

Did you know that slow freezing kills up to 20 percent of the protein solutions in biopharmaceutical liquids? This case study shows how fast freezing with a plate freezer reduces the risk of cryoconcentration dramatically.

Development Of Binding Assays To Measure Interactions Between Fc Regions Of Therapeutic mAbs and Fc Receptors
Poster | By D. Raghu, Y.T. Hsu, L. Kelly, P. Hamill, and M. McKee, MilliporeSigma

It is crucial to evaluate the binding interaction of mAbs with Fc receptors in the early phase of drug development to understand the potential biological activity of the product in vivo.

Continuous Flow Manufacturing Of Pharmaceutical Ingredients
White Paper | Ajinomoto Bio-Pharma Services

Strong growth is anticipated for continuous flow manufacturing of APIs as it offers important advantages over traditional batch manufacturing in terms of quality, safety, and sustainability of the overall process.

Closed And Semiautomated Processing Of CAR T Cells
Application Note | GE Healthcare Life Sciences

This application note describes the details of a robust CAR T cell manufacturing workflow that can be adapted for cGMP compliance in commercial production of CAR T cells.

Cell Line Development Platform For Bispecific Antibody Expression
Poster | JSR Life Sciences

Bispecific antibodies (bsAbs) represent a fast-growing, albeit developmentally challenging, class of molecules offering new therapeutic perspectives. A single-cell system is the most attractive strategy.

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