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Closed Processing for Biomanufacturing

Closed Processing

The facility of the future will require transformation in how biologics are developed and manufactured. Closed processing mitigates contamination and safety risks, maximizes new and existing facility and asset utilization, while enabling sustainable multi-modal manufacturing. With closed processing costly cleanroom and environmental control measures are reduced without compromising product quality. Simplified space design, smaller cleanroom footprints, and increased operational flexibility allow for dramatic cost savings and future-readiness, today.

Operators in a closed processing CNC space

Close your process. Open your possibilities.

With closed processing, you can:

  • Mitigate contamination and safety risks
  • Reduce costly and environmentally demanding cleanroom control measures without compromising product quality
  • Enable connected and continuous process manufacturing
  • Maximize operational flexibility
  • Enable sustainable multi-modal manufacturing

Download our white paper – "Perspectives on: The Adoption of Fully Closed Processing for Biopharmaceutical Manufacturing"

We conducted a global market survey on fully closed processing and gathered industry viewpoints on the topic. Our white paper provides key findings from the research, as well as insights and perspectives from industry experts on the shift towards closed processing and its effects on the facility of the future. Complete the form below to download our paper.

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Value drivers & benefits of closed bioprocessing

Microbe 47% reduction in contamination risk  
Microbe 81% reduction in gowning costs
Microbe 47% reduction in labor time due to reduced gowning, room cleaning, and equipment sanitization  
Microbe Up to 53% reduction in environmental monitoring
Microbe Up to 65% reduction in energy consumption
Gain More Market Insights

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Putting Biologics on the Fast Lane Podcast
Putting Biologics on the Fast Lane Podcast

Tune in & enter the world of Bioprocessing 4.0 with Merrilee Whitney, Chris Hwang and Kelvin Lee. In this podcast we discuss how to accelerate the production of biologics to a rapid pace. 

Related Webinars

Webinar on the benefits of single use closed processing for biopharmaceutical manufacturing
Closed Concept for Biopharmaceutical Manufacturing Webinar

Uncover the benefits and challenges associated with closed processing and learn how innovations in closed single-use systems are driving greater manufacturing efficiency.

Single-use tangential flow filtration for closed processing webinar
Single-Use Tangential Flow Filtration for Closed Processing Webinar

In this webinar, we present the design and performance testing of a single-use manufacturing-scale TFF system that can be operated in functionally or fully closed mode.

Webinar on regulatory expectations when implementing closed single use systems for final filtration and filling operations.
Single-Use Systems - A Prerequisite for Closed Processing in Final Filtration and Filling Operation Webinar

Learn about regulatory expectations when implementing single-use systems for final filtration and filling applications.

Webinar on updates to EU GMP Annex 1 and how this impacts sterilizing filtration in single use systems
How Updates to EU GMP Annex 1 Impact Sterilizing Filtration in Single-Use Systems Webinar

In this webinar, we discuss important elements of the revision to EU GMP Annex 1 and how single-use filtration systems can contribute to a holistic contamination control strategy.

Related Product Categories
Connection/Disconnection for Bioprocessing
Our single-use or stainless steel-based fluid transfer systems feature Lynx sterile connectors and various tubing types to provide sterile fluid transfer between steps in your aseptic bioprocess.
Chromatography Systems for Bioprocessing
Single-use and multi-use chromatography systems are critical for the separation of your valuable molecules. We provide standard and custom systems from pilot to process-scale, offering robust and consistent performance with the processing flexibility you need.
Final Sterile Filtration & Filling
Enhance final filtration and sterile fill processes with pre-sterilized, single-use systems for optimized operations.
Sterile Sampling
Flexible. Safe. Contamination free. Closed system ensures aseptic processing conditions. With configurable holders and single-use sampling assemblies, NovaSeptum® GO sterile sampling system provides representative samples for QC labs testing for bioburden, endotoxin, process sterility, and monitoring pH and osmolality.
Single-Use Assemblies
Streamline biopharma manufacturing with Mobius® 2D and 3D single-use assemblies. From transport to final fill, achieve flexible fluid management.
Sterile Filters
Secure microbial safety with sterile filtration and disposable filters. Choose the right sterilizing filter for effective bioburden control.
Prefilters & Bioburden Control
Boost efficiency: Prefilters remove particulates, enhance column protection, and sterilization. Explore cost-effective options for process improvement.
Tangential Flow Filtration Holders & Systems
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Bacterial Retention Testing
Required by regulatory bodies worldwide, bacterial retention testing (BRT) is a critical step in filter validation. Our skilled validation specialists conduct BRT using each end-user’s worst-case biopharmaceutical processing conditions to ensure a best-case outcome.
Validation Services Consultancy
For local assistance and rapid response to your filtration validation needs, BioReliance® Validation Services offers a global network of highest-quality laboratories with in-country and in-region experts at strategic geographic centers.
Cell Bank Manufacturing
Produce your master and working cell banks in our cGMP compliant facilities, supporting clinical development across a wide range of cell lines with capacity up to 1,000 vials. We can also produce your end-of-production cell bank.
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Biopharma 4.0: Digital Transformation to an Intensified, Closed, Connected, or Continuous Bioprocess
Bioprocessing 4.0 is the convergence of advanced upstream and downstream bioprocessing technologies, PAT, data analytics, automation, and control software for the biomanufacturing facility of the future. The BioContinuum™ Platform provides these building blocks and expertise to help you gain new levels of performance and productivity.
Monoclonal Antibody Manufacturing
Monoclonal antibody manufacturing is a highly templated approach used to produce mAb-based immunotherapies. Robust, scalable process solutions are required at every step to ensure high therapeutic concentration and process safety, while meeting speed-to-market and cost containment concerns.
Antibody-Drug Conjugate (ADC) Manufacturing
Antibody-drug conjugation (ADC) technology uses monoclonal antibodies (mAbs) to deliver potent, highly active pharmaceutical ingredients (HPAPIs) to targeted cells. Learn about processes and areas of expertise required to advance your ADC to market.
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Growing use of gene therapies is driving rapid innovation in an evolving global market. Manufacturers bringing new gene therapies to life face complex challenges, requiring an experienced partner capable of integrating vector manufacturing, testing, safety, process development, and regulatory compliance.
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From early phase development, through downstream purification to large scale vaccine production: learn more about vaccine process development and application expertise.
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Introducing a new cell therapy demands optimal performance in upstream and downstream processing, process development, testing, and manufacturing. World-class products and partners are critical to success, speeding advancement of therapeutics that are effective, safe, and affordable.

Related Products

Pellicon® Capsule with Ultracel® Membrane
Lynx® CDR (Connect, Disconnect, and Reconnect) Connector
Lynx® S2S (Sterile to Sterile) Connector 
Lynx® ST (Steam-to) Connector
NovaSeal™ Crimping Tool
NovaSeptum® SURe assemblies for single-use processes 

External Articles

BioPharm International: Perceptions and Considerations for Adopting Closed Processing
Express Pharma: Is closed processing a reality? 
Proof of Closure: Life Cycle of Closed Systems | Pharmaceutical Engineering (ispe.org)
Biosimilar Development: Transition To Closed Processing Systems For The Expansion Of Suspension Cells And Introduction Of Ballroom Format Cleanrooms For Cell Banking

Related Resources

Brochure: Process Development and Drug Manufacturing: Support Services
We provide comprehensive services for drug development and manufacturing, including technical and regulatory expertise and process development support.

BioContinuum™ Platform: Your enabler of the biomanufacturing facility of the future!

Advanced biomanufacturing technologies for upstream intensification
Upstream (USP) Process Intensification
  • Seed Train Intensification
  • Production & Harvest Intensification
Advanced biomanufacturing technologies for downstream intensification
Downstream (DSP) Process Intensification
  • Intensified Capture
  • Virus Inactivation
  • Flow Through Polishing
  • Single-Pass TFF
PAT for bioprocess monitoring and control of CPPs and CQAs
Process Analytical Technology (PAT)
  • Raman Spectroscopy
  • Automated Aseptic Sampling
Two scientists in the lab reviewing bioprocessing data visualizations on a computer monitor
Bioprocessing Data Analytics Software
  • Bio4C ProcessPad™ Software
Female scientist in lab coat using laptop using control software to automate, monitor, and control a bioprocess unit operation
Bioprocessing Automation and Control Software
  • Bio4C Orchestrator™ Software
  • Bio4C ACE™ Software
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