Manufacturing

This month, Sharon Strause, an industry consultant, provides a look back at "Computer System Validation Part I: Testing and Verification of Applications Software" by Leonard J. Goren.

The European Commission (EC) is seeking to introduce a black symbol to identify medicines that are subject to additional monitoring.

An operation spanning 16 African countries and conducted by the World Customs Organization (WCO) in partnership with the Institute of Research against Counterfeit Medicines (IRACM) led to the seizure of more than 82 million doses of counterfeit medicines.

This case study describes the process used to transition from a multi-use system to single-use tangential flow filtration for performing final buffer exchange steps.

Industry experts from GE Healthcare, Tarpon Biosystems, Polybatics, Merck Millipore, and Repligen discuss the challenges of adapting disposable technology to the chromatography process.

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.

Insights on single-use systems implementation and exploitation in biopharmaceutical manufacturing and processing, based on a QbD approach.

Is process-centered organization in biopharmaceutical manufacturing a stepping stone or a stumbling block?

Scaling up stem-cell cultures requires careful consideration of the bioreactor design.

Creating an effective nucleic acid-based vaccine requires protecting the fragile nucleic acid from degradation, effective transfection of the targeted cells, and producing high enough levels of antigen to evoke a robust immune response.

The author considers the types of tubing available to the industry and how to make an informed selection.

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

This article discusses the evaluation of a novel single-use fluidized bed centrifuge for harvesting of antibodies.

New US Pharmacopeial Convention (USP) standards provide a universal approach to organizing labels for prescription containers dispensed by US pharmacists in an effort to improve patient understanding.

Takeda's US subsidiary, Takeda America Holdings, is to acquire the vaccine specialist company LigoCyte Pharmaceuticals for an upfront payment of $60 million in a move intended to bolster and expand the company’s vaccine business.

Marco Chacon of Paragon Bioservices discusses the challenges associated with outsourced vaccine manufacturing.

Using an alternate moisture-generation method may provide more accurate data for regulatory submissions.

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.

Ties between the biotechnology industry and university research are crucial.

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

The authors describe a validation master plan for closed-vial filling technology.

Manufacturers and regulators struggle to control phony versions of crucial medicines.

There is no harmonized guidance on pre-use integrity testing of sterilizing filters, prompting discussion among users as to whether such testing is necessary.

A one-day sign off for batch records is considered a best practice in the industry.