Exelead Biopharma a MilliporeSigma company
COMPANY PROFILE
Description
Exelead Biopharma, a MilliporeSigma company, specialises in lipid-based and pegylation manufacturing services, providing comprehensive contract manufacturing and development solutions to biotechnology and pharmaceutical companies. As a Contract Manufacturing Organisation (CMO) and Contract Development and Manufacturing Organisation (CDMO), Exelead delivers end-to-end services that encompass a wide range of pharmaceutical needs, including finished dosage formulation and cell and gene therapy.
Services include:
- Regulatory Services
- Protein and Peptide
- Injectables
- Clinical Dose
- Packaging
- Clinical Packaging
- Analytical Services
- 505(b)(2)
- Accelerated Stability Studies
- Agglomeration
- Anti-Counterfeiting Technology
- Aseptic Fill/Finish
- Assay Development
- Bioanalytical Services
- Biological Testing
- Biologics
- Bioprocess Validation
- Bioprocessing
- Biosimilars
- Biostatistics
- Calibration
- cGMP Synthesis
- Chemical Analysis
- Chromatography
- CIP Process Systems
- Clean in Place / Sterilization in Place (CIP/SIP)
- Clean Room Services
- Clinical Analysis
- Clinical Monitoring
- Clinical Trials
- Chemistry (CMC)
- Manufacturing
- Cold Chain Management
- Commissioning
- Consulting
- Records Management
- Six Sigma
- Contaminant Analysis
- Contract Development and Manufacturing (CDMO)
- Contract Manufacturing (CMO)
- Contract Packaging
- Contract Research (CRO)
- Sourcing
- Custom Synthesis
- Distribution
- Documentation Support Services
- Downstream Processing
- Drug Delivery Devices
- Drug Development
- Electronic Data Management
- Endotoxin Testing & Removal
- Engineering and Design Services
- Enterprise Resource Planning
- Environmental Analysis
- Environmental Monitoring
- Testing
- Facility Design & Construction
- Facility Management Services
- Filling
- Syringe
- Vials
- Filtration
- Forced Degradation Studies
- Formulation Development
- Controlled Release
- Genomics and Screening
- Auditing
- Hazardous Waste Management
- IND/NDA Submissions
- Software & Technology
- 21CFR11 / Annex 11
- Data Management
- Process Automation
- Lead Optimization
- Lipids/Phospholipids
- Supply Chain & Logistics
- Lot Release Testing
- Aseptic Fill-Finish
- Bioequivalence
- Clinical Trial Materials
- Controlled Substances
- Ethical
- Generics
- Inhalables
- Liquids
- Nasal Delivery
- Nutraceuticals
- Oligonucleotides
- Ophthalmics
- OTC
- Parenterals
- Small Volume
- Peptides
- Proteins
- Solutions & Suspensions
- Pre-filled
- Vaccines
- Mass Spectrometry
- Materials Analysis
- Clinical Studies
- Metabolic Analysis
- Process Development
- Micro FT-IR Analysis
- Microbiological Control Services
- Microbiological Testing
- Microencapsulation
- Microscopic Analysis
- Nonclinical Research
- Anti-Counterfeiting
- Closures
- Design & Testing
- Contract Development
- Aseptic Fill-Finish
- Glass
- Labelling
- Particle Characterization
- Particle Size Analysis
- Particle Size Classification
- Pharmacodynamics
- Pharmacogenomics
- Physical Testing
- Pilot-Scale Filling
- Preclinical Study Design
- Preclinical Testing
- Preformulation
- Process Analytical Technology (PAT)
- Process Characterization
- Process R&D
- Process Validation Studies
- Project Management
- Quality QA/QC
- R&D Services
- RNAi Technology
- Serialization
- Shipping
- Size Reduction
- Stability
- ICH
- Statistical Analysis
- Sterility Testing
- Sterilization
- Supply Chain Auditing
- Supply Chain Management
- System Integration
- Target Profiling
- Training
- Trays
- UV-VIS Spectrophotometer Analysis
- Validation
- Clinical
- Cleaning Equipment
- Virology
- Warehousing
- Water Testing
- Wet Chemical Analysis
Exelead Biopharma a MilliporeSigma company continues to support the pharmaceutical industry with its extensive range of services designed to meet the evolving needs of drug development and manufacturing. For more information, visit exeleadbiopharma.com.
Capabilities
- Accelerated Stability Studies
- Agglomeration
- Analytical Services
- Anti-Counterfeiting
- Asceptic Fill-Finish
- Assay Development
- Auditing
- Bioanalytical Services
- Bioequivalence
- Biological Testing
- Biologics
- Bioprocess Validation
- Bioprocessing
- Biosimilars
- Biostatistics
- Calibration
- cGMP Synthesis
- Chemical Analysis
- Chemistry (CMC)
- Chromatography
- CIP Process Systems
- Clean in Place / Sterilization in Place (CIP/SIP)
- Clean Room Services
- Cleaning Equipment
- Clinical
- Clinical Analysis
- Clinical Dose
- Clinical Monitoring
- Clinical Packaging
- Clinical Studies
- Clinical Trial Materials
- Clinical Trials
- Closures
- Cold Chain Management
- Commissioning
- Consulting
- Contaminant Analysis
- Contract Development
- Contract Development and Manufacturing (CDMO)
- Contract Packaging
- Contract Research (CRO)
- Controlled Release
- Controlled Substances
- Custom Synthesis
- Data Management
- Design & Testing
- Documentation Support Services
- Downstream Processing
- Drug Delivery Devices
- Drug Development
- Electronic Data Management
- Endotoxin Testing & Removal
- Engineering and Design Services
- Enterprise Resource Planning
- Environmental Analysis
- Environmental Monitoring
- Ethical
- Facility Design & Construction
- Facility Management Services
- Filling
- Filtration
- Forced Degradation Studies
- Formulation Development
- Generics
- Genomics and Screening
- Glass
- Hazardous Waste Management
- ICH
- IND/NDA Submissions
- Inhalables
- Injectables
- Labelling
- Lead Optimization
- Lipids/Phospholipids
- Liquids
- Lot Release Testing
- Mass Spectrometry
- Materials Analysis
- Metabolic Analysis
- Micro FT-IR Analysis
- Microbiological Control Services
- Microbiological Testing
- Microencapsulation
- Microscopic Analysis
- Nasal Delivery
- Nonclinical Research
- Nutraceuticals
- Oligonucleotides
- Ophthalmics
- OTC
- Packaging
- Parenterals
- Particle Size Analysis
- Peptides
- Pharmacodynamics
- Pharmacogenomics
- Physical Testing
- Pilot-Scale Filling
- Preclinical Study Design
- Preclinical Testing
- Preformulation
- Process Analytical Technology (PAT)
- Process Automation
- Process Characterization
- Process Development
- Process Validation Studies
- Project Management
- Protein and Peptide
- Proteins
- Quality QA/QC
- Records Management
- Regulatory Services
- Research & Development
- RNAi Technology
- Serialization
- Shipping
- Six Sigma
- Size Reduction
- Software & Technology
- Solutions & Suspensions
- Sourcing
- Stability Studies
- Statistical Analysis
- Sterility Testing
- Sterilization
- Supply Chain & Logistics
- Supply Chain Auditing
- Supply Chain Management
- Syringe
- System Integration
- Target Profiling
- Testing
- Training
- Trays
- UV-VIS Spectrophotometer Analysis
- Vaccines
- Validation
- Vials
- Virology
- Warehousing
- Water Testing
- Wet Chemical Analysis