REGULATORY
Mycap® CCX Cell Culture Expansion System
Grow cells in the incubator and passage between flasks without ever opening a flask and never going into a biosafety cabinet with MYCAP® CCX.
Saudi Arabia Government Leaders Discuss Agile Manufacturing Beyond Borders
Learn how government leaders in Saudi Arabia planned for biopharma resilience beyond borders and used agile manufacturing to prepare for the unknown.
Cold Chain Expertise For Pharma And Biotech Firms In Regulatory And Quality
PCI is a market leader in the provision of Cold Chain management services and has extensive capacity and unrivaled expertise to accommodate our client’s refrigerated and frozen storage and distribution requirements.Our extensive Cold Chain storage areas are all full...
BioProcess Container (BPC) unpacking and installation Part 2
This video is part 2 of 2 videos that cover the unpacking and inspection of Thermo Scientific BioProcess Containers (BPCs), including both 2D and 3D BPCs, manifolds, and tubing assemblies. In this video we will cover unboxing, inspecting, product support.
Nanoassemblr Blaze mRNA Vaccine Demo
NxGen Technology delivers a scalable means to perform the critical particle formation step in a nanomedicine development process.
Best Practices For Cleanroom Project Delivery And Construction
By offering cleanroom design, manufacturing, and construction, we provide a complete cleanroom project delivery with guaranteed performance.
Accelerate Development With Excipient GMP Quality Cell Culture Solutions
Reduce risk and speed up timelines as you move towards commercialization. Learn about end-to-end services offering Excipient GMP cell culture solutions for streamlined development and regulatory success.
A Scalable Immobilized Metal Affinity Chromatography Media For Process Purification
Downstream process purification of proteins requires a resin with optimized bead size for ideal pressure/flow properties and decent dynamic binding capacity DBC that provides production efficiencies and good process economics. This video explains how our newly developed m...
Cleanroom Classification Zone Creation For ISO 14644, Annex 1, China GMP
Discover a particle counter that automatically determines the number of sample locations needed based on the sampling size of the area, enabling the easy selection of classification for certification.
Parteck® SRP 80 - Reliable Sustained Drug Delivery
Parteck® SRP 80, a functional excipient based on polyvinyl alcohol (PVA), provides reliable sustained drug delivery over long release periods.
Legal & Compliance Impact On Speed In The Antibody Market
In this segment of the Bioprocess Online Live event, Process Development For A Diverse mAb Pipeline, Bayer’s Sr. Director, Bioprocess Technologies, Amir Goudarzi, Ph.D., addresses questions on regulatory impacts on multi-specific antibodies’ path to m...
Supporting The Global Biopharma Industry With Single-Use Capacity Expansion
Explore Cytiva’s brand new single-use production facility in Wales, UK. This facility forms part of Cytiva’s >$1.5 billion investment in increased capacity to support the growing needs of the biopharmaceutical industry and to increase regional supply.
Who's Defining CMC Requirements?
CMC experts discuss what forces and organizations are defining CMC requirements for biologic therapies moving forward.
What Makes The Cell Therapy Business Model Unique?
Adaptimmune’s Adrian Rawcliffe discusses the current and emerging cell therapy landscape and the path to commercialization.
Level Up With Product Characterization
In the race to bring a new biotherapeutic to market, unexpected obstacles can slow you down or even knock you back a few steps. But with the right information at the right time, and an experienced partner to provide scientific, regulatory, and bioprocessing guidance and s...
Just Press Start To Begin Manually Counting Particles In Your Cleanroom
With the press of a button, you can immediately start taking particle counts in your cleanroom using a portable particle counter for easy cleanroom monitoring.
How Patient Access, Mistrust Burden Biosimilars
Celltrion VP of Medical Affairs Hetal Patel, PharmD, MBA addresses challenges such as access, affordability, and trust in biosimilars in this segment of our Bioprocess Online Live panel discussion Impact Of The Biosimilars Boom. She emphasizes the need for transp...
Globalization's Impact on Patient Access with ARM's COO, Rita Johnson-Greene
Rita Johnson-Greene, COO at Alliance for Regenerative Medicine (ARM) joined Cell & Gene: The Podcast Host, Erin Harris, on-site during the 2024 Meeting on the Mesa to record their discussion. Johnson-Greene shared information about the Joint Clinical Assessment (JCA) ...
How Biologic Therapeutics Are Developed
Scientists are harnessing the power of cellular machinery to produce therapeutic biologics that can target specific conditions. Learn about the process of developing a biologic treatment.
OsmoTECH® PRO Multi-Sample Micro-Osmometer From Advanced Instruments
Designed to meet the high sample throughput, regulatory compliance (including 21 CFR part 11), and data management needs of busy bioprocessing and biomanufacturing labs, the OsmoTECH PRO Multi-Sample Micro-Osmometer combines ease-of-use with accurate and precise osmolalit...
Monitor And Control Both Glucose And Lactate In Real-Time
Get faster process insights and dynamic control of substrate feeding without the loss of bioreactor or fermenter volume.
HyPerforma 5:1 Single-Use Bioreactor (S.U.B.) Setup And Installation Part 2
This video is part 2 of 3 videos that cover setup and installation topics related to the HyPerforma 5:1 Single-Use Bioreactor, or S.U.B. In this video we will cover initial BioProcess Container, or BPC, loading, drive shaft insertion, final installation steps.
How To Generate A High-Producing Cell Line In Fast-Track Mode
Cell line development processes can be quite time consuming and labor intensive. When our clients have a very challenging timeline, we can begin process development in parallel with cell line development, further accelerating timelines. What are the risks and how do you m...
CHO Fed-batch Portfolio: Cellvento® And EX-CELL® Advanced Media And Feeds
Cellvento® and EX-CELL® Advanced cell culture media supports consistent growth and performance from development to production. Get the enhanced performance, assured regulatory compliance and the security of supply necessary in today’s biopharmaceutical envir...
Is Evaporation Important For Optical Biosensors?
If your sample is open to evaporation effects causing your concentration to change, will your data, and potentially your conclusions, be unreliable?
Cellvento® 4CHO-X – Prepare Your CHO Cells For Higher Productivity By Optimizing Perfused Seed Train
Learn how to prepare your CHO cells for higher productivity by optimizing perfused seed train. Watch our video and learn how to increase fed-batch production as high as 36%!
Data Quality & Master Files With Dr. Robert Hariri
If ever a biotech unwittingly begged for FDA scrutiny by virtue of its business model, it was Celularity. The company is working on a host of biologic therapies, the development of which is dependent on the large-scale collection of stem cells harvested from afterbirth in...
Evaluating Quality Systems With Your Manufacturing Partners
The landscape surrounding regulatory guidance is constantly changing as the cell and gene therapy industry continues to evolve. Ken Bonnell, Senior Vice President of Quality and Regulatory Affairs, shares insight on what to look for and what is important when evaluating q...
Providing Value Optimized, Time Saving Oligo Solutions
Whether you are in the beginning research stages or ready to take your product to market, our scalable, high quality, and custom oligo and peptide solutions provide the quantities you need using the most reliable, robust, and cost-effective process available.
CDMO + Emerging Bio Partnership With Forge's John Maslowski And Ray's Jenny Holt
What constitutes a healthy, productive, and successful relationship between an emerging biopharma company and its contract development and manufacturing outsourcer (CDMO)? Jenny Holt, Chief Development Officer at the biopharma company Ray Therapeutics has some opinio...