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Projects

New facility for solid state fermentation of enzymes

Supported by NNE, Novozymes built a new facility for solid state fermentation of enzymes in India.

Tags: Biotech and API Facility design Front-end studies Project execution Asia

Projects

Transferring device production across borders

The transfer project aimed to produce NovoPen®4 locally in China as of end 2008 - at a significantly reduced unit cost and to quadruple the production capacity by September 2010.

Tags: Biotech and API Assembly and pack Automation and IT Project execution GMP and compliance Europe Asia

TechTalk

Make informed decisions - estimate unit cost before investment

A vital part of cost-effective pharma productions is balancing investment and unit cost. Find out how unit costs (or operating expenses) are calculated, and what the best route could be for your company.

Projects

Improving environmental performance with a district cooling system at pharma facility site

Customer challenge The customer wishes to improve overall performance, improve environmental performance and lower re-investments of cooling units at their facility site.

Tags: Health, safety and environment Front-end studies Optimization Sustainability Europe

TechTalk

Cut costs with strong automation design for distribution systems | TechTalk

To take a closer look at the physical model, a basic principle for structuring plant equipment into units is that a unit can never hold more than one batch. For example, if a tank and the distribution loop for a water system are placed in separate units , possibly due to a special system configuration, this means the operation of the two units need to be coordinated. Ultimately, a poor definition of units makes the automation solution more...

Projects

Quality strategy for biopharmaceutical manufacturing

Samsung Biologics’s biologics facility, completed in 2013, features a state -of-the-art quality program design by NNE. Then the team initiated the daunting task of performing quality risk assessment (QRA) on all process and utility units . With such a huge amount of units to be assessed, it was imperative to organize it so that time and resources are used in the most optimum way. We thus decided to divide all units into 16 groups according to...

Tags: Biotech and API GMP and compliance Asia

Projects

Flexible design for personalized medicine facility | NNE

Based on technology developed in the United States , Bioheart provides cell treatment for a heart attack by treating stem cell from the patient to implant his own cell after proliferation in the BHM’s production facility.

Tags: Biotech and API Facility design Process engineering Asia

TechTalk

Get closure analysis in pharma manufacturing systems | TechTalk

Understanding the process requires a detailed review of the Process Flow Diagrams (PFDs) and identification of the key unit operations. What is the process state and requirements? To define the process, you must compare your process unit operations with the definition and define a rating. The “closure rating” is a form of risk assessment which considers the closure scale (CS), bioburden control requirement or process requirement (PR) and...

Tags: Closed processes

TechTalk

A breakthrough for pharma manufacturing that is FDA approved

Ultimately a less rigid model that endorses continuous manufacturing solutions can only be beneficial - opening doors for personalized medicine, new dosage forms and cost-efficient clinical trials that meet some important needs of the future. quote Uniting global regulatory authorities Today, support from the European medicines agency (EMA) is formalized in the regulatory framework. Like the US, the FDA and EMA state that existing GMP regulati...

TechTalk

Data-based road map to continuous control strategy and real-time release | TechTalk

This ideal state is illustrated in Figure 1. Each unit operation is continuously monitored, the quality is predicted and proper action taken if this prediction is bad. Figure 1: For each unit operation PIs that can predict CQA and CPPs that can control PIs shall be found and their relations established. In addition, there can also be systematic factors like production units if parallel processing is done. If observations are outside predictio...