Bioreactor Designed for Regulated Environments
The single-use ReadyToProcess WAVE 25 bioreactor system from GE Healthcare Life Sciences is a cell culture device for designed for working volumes in the 0.3 to 25 L range. The system consists of a rocker (ReadyToProcess WAVE 25), a gas mixer (ReadyToProcess CBCU), and a pump (ReadyToProcess Pump 25) operated by UNICORN software installed on a client computer.
The system is equipped with advanced sensors and automated controllers for temperature, liquid handling, pH, and dissolved oxygen (DO). The system can automatically determine suitable parameters for a run based on user-defined set points. Cellbag bioreactor attachment is straightforward and system operation is managed using UNICORN software.
The system is designed to meet the demands of a regulated environment. The software is suitable for use in a manner that complies with 21 CFR Part 11 and Good Automated Manufacturing Practice (GAMP) 5.
Current Issue
Fill/Finish Capacity Use for Biologics
There are significant differences between small molecules and biologics fill/finish capacity.
Drug Breakthroughs, with Some Reservations
New designations lead to faster drug approvals, but there is more work to be done.
Outsourcing
Baxter BioPharma Solutions Joins PBOA
Nelson Patterson has been elected to Pharma & Biopharma Outsourcing Association board.
Fill/Finish Capacity Use for Biologics
There are significant differences between small molecules and biologics fill/finish capacity.
New England CRO/CMO Council Debuts
New organization offers support to contract research organizations and contract manufacturing organizations in the New England area.
Year in Review: Key Outsourcing Trends
Outsourcing is taking on a greater role in the biopharmaceutical manufacturing industry.
Standards/Regulations
Compounding Committee Meets to Discuss Drugs Approved for Compounding
FDA’s Pharmacy Compounding Advisory Committee will meet in February to discuss the list of bulk drug substances that may or may not be compounded.
EMA Sets Elemental Impurities Implementation Dates
New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.
The Quest Continues for Quality Metrics
FDA aims is to collect data regularly from manufacturers that will indicate the ability of a firm and its facilities to produce high-quality therapies on a continual, error-free basis.
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