01.16.22 -- The Data Integrity Body Of Knowledge Expands With New And Pending Guidances
 
Featured Editorial
The Data Integrity Body Of Knowledge Expands With New And Pending Guidances
By Kip Wolf, X-Vax Technology

Some of the contemporary guidance documents for data integrity in biopharmaceuticals and medical devices, both released and in draft, are explained here to better understand their scope and relationship to one another and to provide an example of the ever-changing landscape of data integrity challenges and potential solutions.
Calculating Process Capability Of Cleaning Processes: Analysis Of Total Organic Carbon (TOC) Data
By Andrew Walsh, Miquel Romero Obon, and Ovais Mohammad
How The EU’s Biopharma Industry Can Deliver More With Identification Of Medicinal Products (IDMP) Data Standards
By Frits Stulp, Iperion, a Deloitte business
Industry Insights
Expanding The Boundaries Of Subcutaneous Injections
By Ahmed Besheer
Leveraging Integration At Each Phase Of A Drug Delivery System Project
By Steven Kaufman and Adam Stops, Ph.D.
Using Softgel Innovations To Grow Market Share
By Vince Agostini, Drew Bradley, and David Hall
The Role Of Micronization With Dry Powder Inhaler Technologies
By Andrew Milner
Drive Efficiency, Reduce Waste: New Approach To Sustainable Chemistry
By Kenneth Ball, Pfizer CentreOne
Selecting A CMO Partner For Sterile Injectable Manufacturing
By Harmik Sohi
Four Reasons For The Rise In Blister Packaging
By Yves Massicotte
End-To-End Thinking During Drug Product Development
By Dr. Kashif Ghaffar, Pfizer CentreOne
Test Method Migration Considerations For Container Closure Integrity Testing (CCIT)
By Oliver Stauffer
Navigating Bioconjugate Development: A Q&A
Lonza
Commercial Manufacturing In Half The Time
Asymchem
Leveraging Lessons From The COVID-19 Pandemic To Accelerate The Development And Production Of Viral-Based Gene Therapies
Cytiva
Fixed-Dose Combination Drug Development: Designing A Life Cycle Strategy With Agility And Speed
Thermo Fisher Scientific
Advancements In Antibody-Drug Conjugates (ADCs) Using SMARTag Technology
Catalent
Data Integrity And Data Access Control For Filter Integrity Test Instruments
By Razan Jammal
Key Considerations For Labeling Your Cell Or Gene Therapy
By Abdul Ally and Amy Hendricks
Top Four Considerations For Tech Transfer Performance
By Lei Zheng
The Value Of Expertise In The Aseptic Fill/Finish Of Biologics
By Jon Best, Jeff Tremain, Ted Tharp, and Gene Wloch
Implementing Global Supply Risk Mitigation Through Multisourcing
By David King and Regina Choi-Rivera
How To Build A Robust Packaging Strategy For Rapid Commercialization
By Chris Howell and Brian Kunz
Fundamentals Of Real-Time Viable Particle Monitoring: How Does It Work?
By Patrick M. Hutchins, Ph.D.
Spray-Dried Dispersions Enable Local Delivery For Lung Cancer
By Kimberly Shepard, Ph.D.
Boost Performance With A Chromatography Resin Update
Cytiva
Excel IV: An Evolving Market Affirms The Value Of An Established Offering
B. Braun OEM Division
Scale-Up And Biologics License Application (BLA) Planning For Microbial Biomanufacturing
Lonza
Role Of Organic Co-Solvent (t-Butanol) In Frozen And Freeze-Dried Formulations
SP Scientific Products
Enhanced Single-Use Fermentor (S.U.F.) For Improved Cooling And Oxygen Mass Transfer
Thermo Fisher Scientific
Development Of An Aseptic Transfer System
ChargePoint Technology
Glovebox Design Encloses Milling Processes
Flow Sciences Inc.
Improved Bioavailability In 12 Weeks
Catalent
Engineering Drug Release In EVA-Based Implants
Celanese
Increasing Transparency And Confidence Through Real-Time Data Sharing
By John Chapin and John Morse
Modified-Release Oral Solid Dosage Technologies
By Holger Shen
GxP Facilities Compliance: Six Questions To Ask
By Travis McCready
Achieving Large-Scale Ophthalmic Production
By John Teixeira
Modern Containment Solutions In OSD Processes
By Scott Patterson
Mixing Selection Considerations For Pharmaceutical Tablet Coating Operations
By Matt Smith
Curing Your Complex Oral Solid Dose Challenges
By Amy Trotch and Kieran Coffey
How Does Media Selection Impact Performance Testing Of Poorly Soluble Drugs?
Lonza
Intensified, Improved Fed-Batch Production Process
Cytiva
Pharma Manufacturing’s Digital Journey
MasterControl, Inc.
Capture OTC Market Share For Geriatric And Pediatric Patients
Thermo Fisher Scientific
Overcoming Difficult Cleaning Residues In Life Sciences
Alconox Inc.
How Suppliers And Biomanufacturers Can Collaborate On Knowledge Transfer And Training
Pall
Accelerating Delivery In The Next Stage Of The COVID-19 Battle
Thermo Fisher Scientific