Author Archives: BPI Contributor

Accelerated Development, Manufacturing and Monitoring of Viral Vectors

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The goals of process intensification are to enhance production while shortening timelines, lessening contamination and environmental risks to products and operators, and reducing operating footprints. Previous publications from Sartorius Stedim Biotech (SSB) have highlighted key elements of such activities. In this report, the authors extend the scope of this discussion to tools and technologies that enable intensification of viral vector manufacturing processes. The first article summarizes presentations from a 2018 seminar for viral vaccine manufacturers. Three guest presentations highlighted the…

August 29, 2018

Accelerating Biopharmaceutical Development with High-Throughput Glycan Screening and Multiple Attribute Methodology

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Part 1 Development of biopharmaceuticals comprises many integrated steps, beginning with research and discovery and optimally ending with a commercial therapeutic molecule. Early screening of large numbers of clones and cell culture expression conditions is essential to identifying proteins that carry to greatest likelihood of clinical and commercial success. Part one of this report reviews how high-throughput glycan screening can significantly improve current analytical strategies relating to cell line development. Part 2 Minor impurities and changes in attributes such as…

August 28, 2018

Optimizing Unit Operations In Biopharmaceutical Manufacturing

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There are many critical material-handling challenges regarding flow rates, pressure levels and the prevention of shear in the chromatography, virus filtration and TFF processes that are used in the manufacture of biopharmaceuticals. In order for these unique operations to be implemented successfully while handling fluids that can be sensitive, delicate and expensive, the operator must be aware of their specific operating characteristics and choose a pumping technology that can meet the strict demands for successful operation. While lobe and peristaltic…

August 28, 2018

Pfizer CentreOne Contract Manufacturing

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Pfizer CentreOne is a global contract development and manufacturing organization (CDMO) embedded within Pfizer. We focus on custom API synthesis, sterile injectable fill–finish, and highly potent oral solid dose; and we are a leading supplier of steroid and hormone APIs and intermediates. For more than 40 years, we’ve manufactured complex compounds for our biopharmaceutical partners, guiding their drugs safely from development through commercialization. The Value of the Embedded-CDMO Model: Your molecule is manufactured in the same facilities that produce Pfizer’s…

August 24, 2018

eBook: Biopharmaceutical Training – Train Your Team to Meet Evolving Industry Needs

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Welcome to this year’s focus on industry training programs. In the past three years we’ve brought this information to you in several forms: as a full supplement issue (2016), a featured report (2017) – and now this ebook. Each program that we’ve profiled offers its unique approach to training present and future biotechnologists. The best of the programs offer hands-on training with current equipment provided by supplier partners and with up-to-date approaches to documentation and regulatory requirements. Many university- and…

August 10, 2018

The DeltaV™ PK Controller: Powerful Standalone — Easily Integrated

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The PK Controller brings ground-breaking innovation and technology that is powerful standalone for small units and easily integrates into a plant-wide DCS. With faster logic execution, built-in native Ethernet ports and native device protocols, the DeltaV™ PK Controller addresses a wide variety of applications and system sizes. The fit-for-purpose controller enables you to have a single native database and system allowing you to shorten project schedule and accommodate late changes. What is Powerful Standalone? Operate and configure your standalone applications…

July 30, 2018

Accelerating Intensified Bioprocesses with High-Throughput Small-Scale Tools

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While many biopharmaceutical companies are exploring paths toward continuous processing, many tools already exist for implementing process intensification. As the authors of this special report illustrate, hybrid continuous processes that benefit from single-use technologies along with continuing improvements in perfusion cell culture already now are enabling improvements in cost reduction and accelerating time to market. And novel high-throughput and automated small-scale systems are helping development scientists gather more information in less time than before, reduce their development footprints, and make…

June 26, 2018

KrosFlo KR2i with KONDUiT: Turnkey Benchtop System for Walkaway TFF Automation

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This webcast features: Philip Yuen, PhD, Application Scientist, Repligen Perform efficient, fully automated downstream tangential flow filtration with volumes from 1mL to 10 Liters. Fully integrated and easy to use out of the box, the Spectrum® KrosFlo® KR2i TFF System from Repligen is the lowest priced fully automated system available today that delivers precise and reproducible control and documentation of TFF processes. The system is compatible with hollow fiber or flat sheet filters, and offers a number of user-defined set-point…

June 25, 2018

Setting Up a Rapid Mycoplasma Assay Supporting Recombinant Production

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This webcast features: Kent Persson, PhD, Project Manager, Octapharma Octapharma AB in Stockholm, Sweden, is the site for the NUWIQ® production, a recombinant human FVIII produced in human cells. Regulatory guidelines states that recombinant bulk harvest need to be tested for mycoplasma prior to further processing. The presentation will give the overview on a nearly completed journey on replacing an out-sourced mycoplasma test with Thermo Fisher’s MycoSEQ qPCR assay. Octapharma in Stockholm has recently been sought regulatory approval for the…

May 25, 2018

EZ BioPac® Powder Transfer Gets Your Biologic to Market Faster, with Less Risk

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This whitepaper quantifies how one simple change can drastically reduce the time it takes to get biologics manufactured. Getting media and buffer into large-scale, continuous bioprocessing has been burdensome, time consuming and messy. Upgrading to modern single-use powder handling in your process gets your product to market without time wasted on complicated weigh and dispense steps, cleaning validations, or worries about powder in the air and in the room.

May 11, 2018