Manufacturing

An environmental life cycle assessment comparison of single-use and conventional bioprocessing technology

Single-use technologies offer an attractive option for biopharmaceutical manufacturing, but their environmental impact needs be considered. This paper documents the findings of a Life Cycle Assessment (LCA) study comparing single-use and conventional bioprocessing technology for the production of monoclonal antibodies (MAbs). The study examines the life cycle environmental impacts at 100 L, 500 L, and 2000 L. The results presented focus on the 2000 L production scale. This assessment was reviewed by a third-party review panel. The results demonstrate that…

Six Essential Workflow Steps for Paperless, Automated, End-to-End Environmental Monitoring

The consequences of microbiological contamination range from FDA warning letters through product quarantines and recalls all the way to plant shutdowns. This makes quality control, specifically microbiological and environmental monitoring (EM) a mission-critical priority for pharmaceutical and biotechnology drug manufacturing operations.
Are you currently struggling with integrating a home-grown, paper-based or semi-automated EM system to your LIMS only to find out that it’s error-prone and resource hungry? Are your current LIMS or IT systems over extended when it comes to customizing automated, paperless, mobile data capture and workflow management for EM? Are you searching for a proven, best-practices approach to automate EM and LIMS workflows and reporting in a cGMP environment without hindering new product development and production?

This whitepaper provides an overview of the essential workflow steps for implementing a paperless, automated, end-to-end environmental monitoring solution to increase productivity, reduce compliance risk and generate a healthy return on investment.

Anticipating Success: Meeting the Inherent Challenges of Complex Drug Substances

Realizing the full potential of a novel injectable drug compound is no small task. In the months and years that lead from the exciting discovery phase to the rigorous demands of a commercial launch, unexpected scientific and technical challenges can slow development to a halt, often at key stages. A careful, systematic approach to identifying where and why these roadblocks can occur is fundamental to staying on course. Just as important is a robust, repeatable process design focused on retaining…

Designing Quality into the Product: Early Developability Assessment in Biopharmaceutical Development

The ultimate objective in the development of any new therapeutic candidate is the validation of its mechanism of action and therapeutic efficacy in a clinical setting. Three important areas of product development critical to determining the success of a new drug candidate are: manufacturing, safety, and delivery of the product to patients. Early attrition observed during preclinical stages can often extend development timelines or require additional process optimization, therefore costing the developer more time and money. It is desirable to…

How to Achieve Greater Efficiency in Biopharmaceutical Process Development

Read about GE Healthcare Life Sciences’ support from efficient process development to production through products, consulting services as well as specific, individual collaborations. “Our aim is to help bioprocessing teams to map the optimal plan to transform an idea into results, with greater flexibility and confidence, reducing time and costs along the way. Our global team of bioprocessing experts will support you in the optimization and troubleshooting of existing unit operations or in the design of efficient and cost-effective processes…

Going Paperless from Lab to Plant

The drive to “go paperless” is a strategic initiative that offers demonstrable operational benefits in improving productivity, reducing cycle times and leveraging experimental and operational data along the entire research-development-manufacturing continuum. This technology brief reviews recent initiatives by science-based organizations to develop and deploy software that spans the lab-to-commercialization lifecycle using data standardization/harmonization technology and electronic lab notebooks (ELNs) to streamline technology transfer. Organizations adopting these proven informatics solutions can experience: Enhanced productivity Faster time to market Improved compliance More…

The “early health” Vision

New approaches to vaccine production are needed. GE Healthcare Life Sciences contributes to the “early health” vision by supporting advances in vaccine development through innovative manufacturing solutions that help to shorten time-to-market, increase output, and assure quality.

Preclinical Immunogenicity Assessment

Protein therapeutics can potentially elicit immune responses when administered in humans. These antidrug antibodies could result in partial or complete loss of drug efficacy and other complications that have the potential to cause severe adverse effects in the patient. In this webcast, Philippe Stas, Head of Applied Protein Services at Lonza, discusses the benefits of preclinical immunogenicity assessment, including:

• Early-stage Risk Assessment
• Improved Quality and Safety of Drugs
• Reduced Attrition Rate in Drug Development Programs

View this webcast to learn more about managing drug-induced immune responses at the earliest possible stage to produce safer and more cost-effective protein therapeutics.