Newsletter | September 11, 2019

09.11.19 -- Project Execution Models For Biopharmaceutical Facilities

  Maximize Cycles. Minimize Volume.

What is the best way to improve productivity and efficiency of downstream operations? That depends — on your existing infrastructure, batch sizes, and facility utilization. This article will guide you in choosing an intensified chromatography strategy that best fits your facility.

Read article: Intensified Chromatography Strategies

Featured Editorial
Project Execution Models For Biopharmaceutical Facilities
By Erich H. Bozenhardt and Herman F. Bozenhardt

Project execution and management are often-covered, yet ill-understood topics in the biopharmaceutical industry. This article is not about the theory of management, but it is a primer on approaches to project execution, some of which may assist the reader in understanding their path of least risk.

Fixing The Follow-On Insulin Regulatory Approval “Dead Zone”
By Chad A. Landmon and Christopher M. Gallo, Ph.D., Axinn, Veltrop & Harkrider LLP

With all the attention on the costs of pharmaceutical products, there is an upcoming regulatory “dead zone” that will potentially delay market entry of certain insulin products, adversely impacting insulin prices for consumers and payors. A recent Senate bill has been proposed to address this regulatory anomaly. 

Industry Insights
Achieving Operational Efficiency In Today’s Fragmented Market
Article | By Joseph Makowiecki and Madhu Raghunathan, GE Healthcare Life Sciences

Meeting the goals of today’s industry requires a deeper look at how to continuously achieve maximum utilization and reduce waste without sacrificing quality in the race to be first to market. 

Are "Do-Overs" Practical In Biopharmaceutical Manufacturing?
Article | By Josh Eaton, Parenteral Drug Association (PDA)

What should a manufacturer do when an API or intermediate from a biopharma manufacturing process does not meet specification, or when a process has operated outside the validated operating range? 

Using A CMO To Streamline Process Characterization
White Paper | By Evan Pasenello and Daniel Sayut, AbbVie

While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex. 

Controlling Preanalytical Variability In Biospecimen Collections
E-Book | By Abdul Ally, Thermo Fisher Scientific

Health and lifestyle information of population study participants, linked to biospecimen samples, allow investigators to examine the intricate relationships between genetics, physiology, behavior, environment, and disease. This eBook is an introduction to some of the variables that must be considered when collecting biospecimens as part of a cohort study.

rAAV Production In Suspension CAP GT Cells In BioBLU Single-Use Vessels
Application Note | By Simon Fradin, Kerstin Hein, and Helmut Kewes, Cevec Pharmaceuticals GmbH; and Robert Glaser, Ulrike Rasche, and Ma Sha, Eppendorf

Researchers at Cevec Pharmaceuticals adapted a small-scale shake flasks rAAV production process to stirred-tank bioreactors and scaled it up in BioBLU Single-Use Vessels from a working volume of 2 L to 10 L. Scale-up in bioreactors was based on constant power input/volume. It led to comparable cell growth and virus production at both scales and to the original shake flask process.

Purification Of A Recombinant Monoclonal Antibody — Rituximab Biosimilar — With A Nonaffinity-Based Chromatographic Process
Poster | Bio-Rad Laboratories, Inc.

Protein A resins have two major disadvantages, high cost and low resin stability. We evaluated the purification of the recombinant antibody rituximab using a non-Protein A purification scheme. This included a cation exchange (CEX) resin for capture purification, followed by anion exchange (AEX) resin for intermediate, and a hydroxyapatite (mixed mode) media for polish purification. Simultaneous purification was performed with a Protein A workflow.

Single-Use Fermentor Process Optimization And Scale-Up Of Microbial Cultures
Poster | Thermo Fisher Scientific

Recent innovations in single-use technologies (SUT) have allowed traditional microbial fermentation processes to quickly capture the established benefits that have been proven over the past decade with animal cell culture processes when using disposable processing equipment.

Designing Complex Release Oral Solids
Infographic | Catalent

Learn how controlled and modified release can provide improved compliance and therapeutic effectiveness with the right release profile based on API properties, PK challenges, and patient needs.

Top 3 Reasons To Select BioFlex TPE Tubing
Meissner Filtration Products
ScreenFect A: DNA And siRNA Transfection Reagent
FUJIFILM Wako Chemicals U.S.A. Corp.
Process Impurities: Don’t Let PEI Or HCP Derail Your Biotherapy

Thursday, September 12, 2019 | 11:00 AM EDT

The manufacturing of a biotherapy involves multiple inputs, ranging in complexity from a transfection reagent to the host cell in which the therapy is manufactured. All of these process components should be removed prior to the therapy being available for human use. During this webinar we will review strategies within product characterization to de-risk the manufacturing process for cell and gene therapies and monoclonal antibodies (mAbs).

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