Newsletter | September 5, 2019

09.05.19 -- Project Execution Models For Biopharmaceutical Facilities

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

Project execution and project management are probably two of the topics that are most written about but least understood by the biopharmaceutical industry. This article is not about the theory of management but rather a primer on approaches to project execution, some of which may assist the reader in understanding their path of least risk.

Negotiating Quality Technical Agreements: Strategies For Nonquality Professionals
By Ray Sison, xCell Strategic Consulting, LLC

Of the four critical documents that must be negotiated and executed by both sponsor and CDMO (NDA, quotation, MSA/SA, and QTA), the QTA (quality technical agreement) is often the least-prioritized by the procurement team. Yet, in practice, the QTA will be the most useful for development- and clinical-stage companies, because it provides a framework for operations and a road map for building quality systems.

Industry Insights
Validation Of A Glovebox Workstation
White Paper | By Jan Eudy, cleanroom/contamination control consultant, ISO 9000/cGMP auditor, HACCP/food safety auditor

Many existing research labs, pharmaceutical and biopharmaceutical manufacturers, and contract manufacturing organizations (CMO’s) are not designed nor are they equipped with the engineering controls to safely handle the manufacture of ADC’s. The safe manufacture of ADC’s requires more modern facilities, equipment, and engineering controls as well as programs, practices, and procedures to adequately protect the operators and the work environment. Read the steps that must be taken to consider a glovebox workstation fully validated to manufacture ADCs safely.

Optimizing Process Efficiency In Upstream Manufacturing
White Paper | By Dr. Andreas Castan, GE Healthcare Life Sciences

Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency — a key goal for biopharma production.

Overcoming Bioavailability Challenges In Oral Formulation Development
White Paper | By Sundeep Sethia, Ph.D., Pharmaceutics International

With nearly 90 percent of the developmental pipeline drugs consisting of poorly soluble molecules, formulation experts must be prepared to address this obstacle by applying various approaches to improve an API’s pharmacokinetics. 

Accelerate Process Development With High-Throughput, Single-Use, Fully Automated Bioreactors
White Paper | By Mwai Ngibuini, Sartorius Stedim Biotech

Biopharma R&D teams everywhere face the same dilemma in the development of biologics and vaccines: to increase productivity to meet strict budgets and deadlines, while maintaining or improving data accuracy.

Aseptic Blow-Fill-Seal: A Sustainable Process For Packaging Pharma Liquids
White Paper | By Chuck Reed, past ISPE chairman, Packaging COP

Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and processes that provide critical advantages for sustainable initiatives.

Steps Ahead: Planning For Future Equipment Surpluses From The Point Of Procurement
White Paper | By Justin Kadis, Federal Equipment Company

Planning and preparation are the keys to success in any enterprise, and making plans for the possibility of equipment liquidation from the time of procurement is no exception. There are clear advantages to planning for your facility’s future, especially if it includes the opportunity for cost savings or a new way to look at purchasing budgets.

Patient-Centric Drug Design: A Clinical And Academic Perspective
Article | By Dr. Rachel Meyers, clinical associate professor in the Pharmacy Practice Department at the Ernest Mario School of Pharmacy, Rutgers University

Most issues in pediatric drug development arise from the fact that drugs are traditionally developed for adults and not children. Dr. Meyers shares the hurdles and improvements in pediatric drug development.

Critical Opportunity For Pharmaceutical And Process Understanding
Article | Dassault Systemes Americas

Continued process verification (CPV), process analytical technology (PAT), and quality by design (QbD) are driving pharma to improve product and process quality and efficiency.

Now & Next: Mavupharma
Q&A | Jubilant Biosys

Saurabh Kapure, vice president, business development, USA for Jubilant Biosys, recently sat down with Michael Gallatin, Ph.D., president and cofounder of Mavupharma (Mavu), the drug discovery and development company, to discuss some of the latest developments in the industry and at Mavu. In this Q&A, Dr. Gallatin shares his thoughts about Mavupharma, his role at the company, the evolution of biopharma, drug discovery, development, and the road ahead for the industry, with Saurabh.

Cell-Based Assays In A GMP Environment: Approaches For Clinical And Commercial Stability Studies
Webinar | By Ming Li, Ph.D., and Aryo A. Nikopour, Nitto Avecia Pharma Services

This presentation demonstrates that in vitro, cell-based assays are an indispensable tool to quantify the biological activities, and to support the potency tests, for biotherapeutics.

Why Are Lipid Formulations Commonly Used To Enhance Bioavailability?
Webinar | Thermo Fisher Scientific

In this webinar, Thermo Fisher Scientific's Kaspar van den Dries and Helena Teles discuss potential mechanisms of increased absorption with lipid formulations and appropriate screening tools that are used during the development approach of these formulations. They also cover subsequent steps to scale up and industrialize these formulations.

Protecting Oxygen-Sensitive Formulations Throughout The Product Life Cycle
Webinar | Lighthouse Instruments

Many biopharmaceutical drug formulations have some degree of oxygen sensitivity. Topics for this webinar include how oxygen levels in finished parenteral drug containers can be determined for oxygen scavenger and stability studies, for determining inherent primary packaging integrity, and for optimizing and qualifying inert gas purging systems during filling.

GE Healthcare Life Sciences Webinar: Smarter Development Of Chromatography Processes

September 24, 2019 | 11:00 a.m. EDT

Smart process development is a collection of approaches to make process development better and faster — providing the developers with tools to face the rapidly changing landscape. This webinar will review three fields that enable reduced timelines and improved outcomes of process development activities:

  • In-silico process development and data-driven decisions
  • Management of process variability through deeper process understanding
  • Use of high-throughput methodologies
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