Facility Design and Engineering

Additional challenges to the new cleanroom paradigm from concurrent multiproduct manufacturing of bulk drug substances in a controlled non-classified (CNC) ballroom environment.

The move to single-use manufacturing has prompted a paradigm shift in facility design.

NIBRT's Michael Lacey provides an overview of biopharmaceutical facility design and operation.

This article describes best practices for implementing a single-use process train at a bioproduction facility.

The combination of single-use platform technology with modular facility construction is a template for flexible manufacturing.

A brief case study of a facility-fit analysis provides insight into how to adjust capacity when moving from clinical-to commercial-scale production.

The authors explain why Catalent decided to transition from stainless steel to single-use systems.

GE Healthcare Life Sciences' ReadyToProcess platform aims to streamline bioprocessing.

Patrick Jackson of Vindon Scientific offers key considerations for choosing an outsourced sample storage facility.

Anne Marie Dixon of Cleanroom Management Associates, gives us an update on her 1988 article, "Clean Room Management."

ISPE has published a new guidance titled ISPE Good Practice Guide: Quality Laboratory Facilities, which defines design guidelines for quality laboratories.

Using a competency-based approach to effectively train biopharmaceutical industry staff.

The authors re-examine environmental controls in the context of technical advances in manufacturing.

Case studies show TOC is effective for cleaning validation.

An algorithmic approach to fine tune facility design and predict capacity.

How to improve facility design and predict capacity.

A case study compares capital costs, operating expenses, and NPV for a new MAb plant.

To assess current trends in cleanrooms and engineering & facilities, BioPharm International turned to Parrish Galliher, founder and chief technology officer, Xcellerex, Inc.; Jim Maslowski, owner, PDC Aseptic Filling Systems; Morgan Polen, vice president, application technology, Lighthouse Worldwide Solutions; and Benoît Verjans, commercial director, Aseptic Technologies.

A close-up look at Pfizer's biotherapeutics plant in Shanbally, Ireland.

The development of a skilled labor force is essential for an expanding biopharmaceutical industry.

In new disposables projects, it is critical that engineering, procurement, and operations groups work together early on to manage supply chain risk.

Four reasons why outsourcing may be the best option, and key factors to consider when selecting a provider.

There could be a serious glut of commercial scale mammalian cell culture capacity over the next five years. Then again, there could be a significant shortage. It all depends on how things develop in expression technology, the new product pipeline, and corporate strategies.

When making critical decisions such as whether to build or buy critical capabilities, companies need a decision-making approach that weighs risks and rewards as a science with adequate inputs, repeatable processes, and measurable results. The method must also accommodate the human factor by encouraging wide participation and providing the kind of neutral decision criteria that satisfies participants about the objectivity of the process.

Manufacturers of biopharmaceuticals can improve productivity by taking patient wellness into account.

In addition to making technical developments, vendors are also looking at ways to improve supply-chain security. By offering standard, off-the-shelf products, vendors are able to shorten lead times and improve the security of supply.

Bayer Schering Pharma AG, (Berlin, Germany) has completed the acquisition of a biologics manufacturing facility in Emeryville, CA, from Novartis.

Discovery Laboratories (Warrington, PA) could see the end of its struggle to launch its Surfaxin (lucinactant) drug on the US market soon, as the manufacturing issues it has faced have been resolved.

PAREXEL Consulting (Boston, MA) has hired three senior GMP consultants based in Europe with the hope of helping its clients address complexities of European Union directives in areas such as manufacturing regulations, quality, and safety.