The authors describe considerations and best practices for meeting drug substance uniformity.
Phil Wagner
Advertisement
Articles by Phil Wagner
Advertisement
Latest Updated Articles
Advertisement
Advertisement
- News
- Multimedia
- Publication
- Conferences
- Resources
- Subscribe
- Webcasts
- BioBusiness
- BioPharm Products
- BioPharm Sponsored Ad
- Biopharmaceutical Analysis
- Analytical Best Practices
- Analytical Methods
- Lab Furnishings and Equipment
- Contract Analytical Services
- Finished Product Analysis
- Drug Substance Analysis
- Biopharmaceutical Analysis: GC-MS
- Biopharmaceutical Analysis: Mass Spectrometry
- Biopharmaceutical Analysis: ICP-MS
- Biopharmaceutical Analysis: NMR
- Biopharmaceutical Analysis: Raman
- Biopharmaceutical Analysis: Gas Chromatography
- Biopharmaceutical Analysis: LC-MS
- Biopharmaceutical Analysis: HPLC/UHPLC
- Analytical Instrumentation
- Biosimilars and Biobetters
- Deals, Development and Manufacturing
- Development
- Formulation
- Process Validation
- Drug Delivery
- Process Development
- Scale Up
- Excipients
- API Synthesis and Manufacturing, Large Molecule
- Formulation and Drug Delivery, Combination Drugs
- Early Phase Development
- Formulation and Drug Delivery, Biologic Drugs
- Formulation and Drug Delivery, Parenterals
- Formulation and Drug Delivery, Specialty Dosage Forms
- Formulation and Drug Delivery, Controlled Release
- Formulation and Drug Delivery, Liquids
- Formulation and Drug Delivery, Solid Dosage
- Formulation and Drug Delivery, Other
- Discovery Pipeline
- Disposables Advisor
- Downstream Processing
- Elements of Biopharmaceutical Production
- From the CEO
- From the Editor
- Inside Standards
- Interphex Keynote Sessions
- Manufacturing
- Manufacturing, Monoclonal Antibodies
- Manufacturing Systems, Single-Use
- Vaccine Development and Manufacturing
- Manufacturing, Aseptic Processing
- Manufacturing, Fill/Finish
- Facility Design and Engineering
- Process Control, Automation, and PAT
- Supply Chain/Logistics
- Manufacturing Best Practices
- Information Technology
- Technology Transfer
- Manufacturing Equipment, Upstream Processing
- Manufacturing Equipment, Biologics
- Cleanroom Equipment and Supplies
- Manufacturing, Parenterals and Injectables
- Clinical Trial Materials
- Manufacturing, Biosimilars and Biobetters
- Manufacturing, Lyophilization
- Manufacturing, Combination Drugs
- Manufacturing, Solid Dosage Drugs
- Manufacturing, Topical Drugs
- Manufacturing, Biologics
- Manufacturing, Specialty Dosage Forms
- Manufacturing, Nucleic Acids
- Manufacturing, Liquid Drug Products
- Manufacturing, Drug Products
- Manufacturing, Cell Therapies
- Manufacturing, Recombinant Proteins
- Manufacturing, Continuous Biologics Processing
- Manufacturing, Gene Therapies
- Packaging, Labeling, and Distribution Systems
- Outsourcing
- Clinical Trial Services
- Perspectives on Outsourcing
- Contract Services, Regulatory Consulting
- Contract Packaging, Logistics, and Distribution
- Contract Manufacturing, Sterile, Aseptic Processing
- Contract Manufacturing, Biopharmaceutical Production
- Contract Manufacturing, Drug Substance, API
- Contract Manufacturing, Finished Drug Product
- Contract Manufacturing, General
- Contract Services, Formulation and Drug Delivery
- Peer-Reviewed Research
- Pharmacopoeial Compliance Series
- Quality/GMPs
- Ask the Expert
- Regulatory/GMP Compliance
- Compliance Notes
- Regulatory Beat
- European Regulatory Watch
- Adverse Events and Recalls
- Regulatory/GMP Compliance, Europe
- Regulatory/GMP Compliance, Emerging Markets
- Audits and Inspections
- Anticounterfeiting, Track and Trace Systems
- Quality by Design
- Compendial Compliance
- Standard Operating Procedures (SOPs)
- Quality Control/Quality Assurance
- Regulatory Filings and Submissions
- Regulatory Authority Actions
- Therapeutic Specific Areas
- Upstream Processing
- Viewpoints
- Weighing Up Big Pharma