Single-use bioprocessing equipment engineer and expert Paul Priebe has some advice for you. Next time you catch yourself questioning an equipment standard (or the lack thereof), take a good look in the mirror.
- New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies
- How To Unlock Efficiency In MES Integrations
- Nitrosamines: New WHO Guidance Provides Expanded Risk Assessment Considerations
- SUS, PAT, And Other Tech Advancing Upstream Bioprocessing
- Integrating Quality Processes And Documentation After A Merger
- GMP Plant Uniform Lockers And Procedures: Best Practices
- What Time Is Best To Bring My CDMO On Board?
GUEST COLUMNISTS
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How To Unlock Efficiency In MES Integrations
This article outlines the significant benefits and framework for manufacturing execution system (MES) integration with systems such as enterprise resource planning.
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Nitrosamines: New WHO Guidance Provides Expanded Risk Assessment Considerations
Nitrosamines are potential contaminants of drug products. Contamination can occur from synthesizing APIs and excipients, from leaching into the product from primary packaging, and more.
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SUS, PAT, And Other Tech Advancing Upstream Bioprocessing
As the sector grows, technology and techniques are becoming more sophisticated, including single-use systems, automation, and bioreactors.
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Integrating Quality Processes And Documentation After A Merger
If your company is undergoing a merger, you must juggle operations while ensuring minimal disruptions. You'll need a holistic view of QMS and SOPs to harmonize procedures.
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GMP Plant Uniform Lockers And Procedures: Best Practices
As the use of GMP plant uniforms has gained acceptance, locker room layouts have arisen across companies and sites. This article examines alternatives and optimized approaches.
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What Time Is Best To Bring My CDMO On Board?
The answer might be sooner than you think and entail more transparency than you're used to.
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FDA Publishes Final Guidance On Reporting Listed Drug Amounts
Despite earlier efforts to shore up the U.S. drug supply chain, COVID-19 still brought shortages. A new FDA reporting system aims to reduce future supply risks.
BIOSIMILAR WHITE PAPERS
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Manufacturing Challenges With High Concentration Biologics
Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.
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Frontiers In Digital Bioprocessing: Modular Plant Automation And Cloud5/26/2022
As the biopharmaceutical industry is embracing digital transformation and thus evolves in its digital maturity, future-ready concepts will play a leading role in the shift toward bioprocessing 4.0.
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Taking Charge Of Your Stability Program10/5/2022
Conducting stability studies is a critical aspect of the drug development process. Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more.
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Quantitation Of Monoclonal Antibodies In Serum2/8/2024
Monoclonal antibodies (mAbs) are a rapidly growing group of targeted therapeutics. Gain insight into the importance of optimized bioanalytical assay platforms for mAb development.
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Five Essentials For Accurate Oligonucleotide Chemistry3/4/2024
Explore five key areas in oligonucleotide chemistry where improvements will have a huge influence on your synthesis quality.
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Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars2/9/2024
The presence of anti-drug antibodies (ADAs) can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.
BIOSIMILAR APP NOTES & CASE STUDIES
- TFF For Laboratory And Process Development Applications
- Generating A Robust Host Cell Line For A Cell Line Development Platform
- Getting CMC Right For Emerging Technologies
- Maximize Product Recovery In Bulk Filtration And Filling Flow Paths
- How To Ensure Correct Component Selection When Outsourcing To A CMO
BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS
The debate over whether the biosimilar regulatory paradigm can shift away from comparative efficacy trials has intensified over the past few years. This collection of articles serves as a snapshot of the many different components of this ongoing discussion.
More Content CollectionsBIOSIMILAR DEVELOPMENT NEWS
- Teva And Alvotech Announce SIMLANDI® (adalimumab-ryvk) Injection Now Available In The US
- Be The Most Trusted Biotech Company
- Boehringer Ingelheim Expands Access To Adalimumab-adbm Injection, The Company's Biosimilar To Humira®
- Xbrane And Stada Partner With Valorum Biologics To Commercialize Ranibizumab Biosimilar Candidate In The US
- mAbxience Appoints Jurgen Van Broeck As New CEO
- Celltrion USA's adalimumab-aaty Biosimilar To HUMIRA® Now Available At Low Wholesale Acquisition Cost
- Rani Therapeutics To Present Clinical And Preclinical Data On Oral Delivery Of An Ustekinumab Biosimilar Via The RaniPill® Capsule At Digestive Disease Week 2024
- Biosimilars Canada Announces Re-Election Of Board Chair And Vice-Chair
NEWSLETTER ARCHIVE
- 05.16.24 -- Integrating Quality Processes And Documentation After A Merger
- 05.14.24 -- Let's deviate from deviations - Sterile drugs.
- 05.09.24 -- Sandoz, Amgen Resolve Denosumab Patent Litigation
- 05.02.24 -- Designing Highly Agile Biopharma Manufacturing Facilities
- 04.25.24 -- How Continuous Manufacturing Is Shaping Biopharma