CAPABILITIES
OVERVIEW
Mission CDMO offers a wide range of contract services to accommodate the diverse development and commercialization needs of our customers. Our highly- skilled and dedicated employees work diligently to provide dynamic project support for product development and technical transfer activities. As your CDMO partner, we work as an extension of your own operations in executing your vision and exceeding your expectations.
DEVELOPMENT
Our experienced team of formulators and analytical chemists can readily develop and scale formulations, including semi-solids as well as solid and liquid oral dosage forms. We can support multiple Abbreviated New Drug Applications (ANDAs) and New Drug Applications (NDAs) and we are strongly positioned to meet the growing consumer demand for high-quality, American-made pharmaceutical products.Development Services offered:
- Pre-formulation Studies
- Formulation and Process Development
- Packaging Development
- Analytical Method Development and Validation
- Registration and Clinical Supply Manufacturing
ANALYTICAL
Offering a full spectrum of analytical services from method development to finished product release and ICH stability testing, Mission CDMO’s dedicated analysts are highly-proficient in advanced laboratory techniques and work diligently to provide the analytical support that our customers need. Our analytical team also works closely with our highly-experienced R&D department to aid development operations in new material qualifications and technical transfer activities. With the assistance of our analytical services group, Mission CDMO has the ability to not only maintain current quality and product partnerships, but also to excel in new product development and commercial growth.
Analytical Services offered:
- Method Transfer
- Cleaning Validation/Verification
- ICH Stability Testing and Storage
- USP/NF Testing
- In-Process and Release Testing
Analytical Instrumentation/Capabilities:
- GC (FID and headspace)
- HPLC (PDA/dual wavelength detectors/MS/ELSD/RI)
- UPLC
- IC (Conductivity)
- Atomic Absorption Spectrophotometer
- UV/VIS Spectrophotometer
- Franz Cell (IVRT)
- Dissolution (USP type 1 and 2)
- FT-IR
- ICP Mass Spec
- Laser Particle/Globule Size Analyzer
- TOC
- Osmometer
- Fluorometer
- Optical Microscope (Equipped with Camera)
- Polarimeter
- pH Meter
- Pycnometers
- Digital Rheometer
- Digital Viscometers
MANUFACTURING
Offering a full range of contract services and over seven decades of product development and manufacturing experience, Mission CDMO is the ideal partner for domestic and international pharmaceutical companies of all sizes. Our manufacturing facility currently features 275,000+ square feet of space in 4 buildings. We meticulously maintain this environmentally-controlled, highly-secured facility on our expansive 40-acre campus that is centrally located in Boerne, Texas. Mission CDMO strictly adheres to current Good Manufacturing Practices (cGMPs) and we are regularly audited by our customers and governmental health authorities. We are always inspection ready!
Technical Services offered:
- Process Development and Optimization
- Technology Transfer
- Scale-up
Semi-Solid (Topical) and Liquid (Topical and Oral) Capabilities:
- High- and Low-Shear Mixing
- Heating, Cooling, and Gradient-Capable Jacketed Vessels
- Pressure and Vacuum Rated Vessels
- Available Versator and Nitrogen Blanketing
Tablet Capabilities:
- High-Shear and Fluid-Bed Granulation
- Direct Compression
- Aqueous and Organic Coating
- Immediate and Controlled Release
- Blending
- Milling
- Particle Sizing
- Co-Melts
PACKAGING AND WAREHOUSING
Mission CDMO offers a wide range of packaging capabilities and configurations. Separate environmentally-controlled suites house each packaging line to prevent cross-contamination and protect process integrity and quality.
Our warehousing facilities provide a secure, environmentally-controlled storage space for raw materials, packaging components, and finished goods. We provide total turnkey component and product inventory sourcing and management with electronic data interchange (EDI) capabilities.
DSCSA Compliant (Serialization) and Unique Device Identification (UDI) Capabilities:
- Bottle Filling (Liquids, Semi-Solids, and Tablets)
- Tube Filling
- HDPE
- LDPE
- Aluminum
- Jar Filling
- Blister Packaging and Co-Packaging
- Sachets (Semi-Solids and Tablets)
- Cotton and Desiccant Placement
- Labeling (including Extended Content Labels)
- Cartoning
- Bundling
- Tray Packing
Warehouse:
- Environmentally-Controlled and Monitored
- Cold Storage
- National Association of Boards of Pharmacy® (NABP®) Drug Distributor Accreditation
- Licensed to ship into all 50 States
REGULATORY SUPPORT
Mission CDMO offers an array of regulatory services, with extensive experience in submitting multiple Abbreviated New Drug Applications (ANDAs) and New Drug Applications (NDAs). From the development phase to commercialization, Mission CDMO can provide regulatory assistance to our partners for any stage of your product life cycle.Regulatory Support Services offered:
- Regulatory Compliance Support
- Regulatory Agency Meetings
- Document Quality Review
- Regulatory Electronic Submission Preparation and Publishing Services
- Electronic (eCTD) Submissions via ESG
- Labeling Strategy and Target Product Profiles
- Licensing Services
- CMC Strategy and Authoring
- Advertising and Promotional Material Review/OPDP Submissions
- Pharmacovigilance Services
DEVELOPMENT
Our experienced team of formulators and analytical chemists can readily develop and scale formulations, including semi-solids as well as solid and liquid oral dosage forms. We can support multiple Abbreviated New Drug Applications (ANDAs) and New Drug Applications (NDAs) and we are strongly positioned to meet the growing consumer demand for high-quality, American-made pharmaceutical products.Development Services offered:
- Pre-formulation Studies
- Formulation and Process Development
- Packaging Development
- Analytical Method Development and Validation
- Registration and Clinical Supply Manufacturing
ANALYTICAL
Offering a full spectrum of analytical services from method development to finished product release and ICH stability testing, Mission CDMO’s dedicated analysts are highly-proficient in advanced laboratory techniques and work diligently to provide the analytical support that our customers need. Our analytical team also works closely with our highly-experienced R&D department to aid development operations in new material qualifications and technical transfer activities. With the assistance of our analytical services group, Mission CDMO has the ability to not only maintain current quality and product partnerships, but also to excel in new product development and commercial growth.
Analytical Services offered:
- Method Transfer
- Cleaning Validation/Verification
- ICH Stability Testing and Storage
- USP/NF Testing
- In-Process and Release Testing
Analytical Instrumentation/
Capabilities:
- GC (FID and headspace)
- HPLC (PDA/dual wavelength detectors/MS/ELSD/RI)
- UPLC
- IC (Conductivity)
- Atomic Absorption Spectrophotometer
- UV/VIS Spectrophotometer
- Franz Cell (IVRT)
- Dissolution (USP type 1 and 2)
- FT-IR
- ICP Mass Spec
- Laser Particle/Globule Size Analyzer
- TOC
- Osmometer
- Fluorometer
- Optical Microscope (Equipped with Camera)
- Polarimeter
- pH Meter
- Pycnometers
- Digital Rheometer
- Digital Viscometers
MANUFACTURING
Offering a full range of contract services and over seven decades of product development and manufacturing experience, Mission CDMO is the ideal partner for domestic and international pharmaceutical companies of all sizes. Our manufacturing facility currently features 275,000+ square feet of space in 4 buildings. We meticulously maintain this environmentally-controlled, highly-secured facility on our expansive 40-acre campus that is centrally located in Boerne, Texas. Mission CDMO strictly adheres to current Good Manufacturing Practices (cGMPs) and we are regularly audited by our customers and governmental health authorities. We are always inspection ready!
Technical Services offered:
- Process Development and Optimization
- Technology Transfer
- Scale-up
Semi-Solid (Topical) and Liquid (Topical and Oral) Capabilities:
- High- and Low-Shear Mixing
- Heating, Cooling, and Gradient-Capable Jacketed Vessels
- Pressure and Vacuum Rated Vessels
- Available Versator and Nitrogen Blanketing
Tablet Capabilities:
- High-Shear and Fluid-Bed Granulation
- Direct Compression
- Aqueous and Organic Coating
- Immediate and Controlled Release
- Blending
- Milling
- Particle Sizing
- Co-Melts
PACKAGING AND WAREHOUSING
Mission CDMO offers a wide range of packaging capabilities and configurations. Separate environmentally-controlled suites house each packaging line to prevent cross-contamination and protect process integrity and quality. Our warehousing facilities provide a secure, environmentally-controlled storage space for raw materials, packaging components, and finished goods. We provide total turnkey component and product inventory sourcing and management with electronic data interchange (EDI) capabilities.DSCSA Compliant (Serialization) and Unique Device Identification (UDI) Capabilities:
- Bottle Filling (Liquids, Semi-Solids, and Tablets)
- Tube Filling
- HDPE
- LDPE
- Aluminum
- Jar Filling
- Blister Packaging and Co-Packaging
- Sachets (Semi-Solids and Tablets)
- Cotton and Desiccant Placement
- Labeling (including Extended Content Labels)
- Cartoning
- Bundling
- Tray Packing
Warehouse:
- Environmentally-Controlled and Monitored
- Cold Storage
- National Association of Boards of Pharmacy® (NABP®) Drug Distributor Accreditation
- Licensed to ship into all 50 States
REGULATORY SUPPORT
Mission CDMO offers an array of regulatory services, with extensive experience in submitting multiple Abbreviated New Drug Applications (ANDAs) and New Drug Applications (NDAs). From the development phase to commercialization, Mission CDMO can provide regulatory assistance to our partners for any stage of your product life cycle.Regulatory Support Services offered:
- Regulatory Compliance Support
- Regulatory Agency Meetings
- Document Quality Review
- Regulatory Electronic Submission Preparation and Publishing Services
- Electronic (eCTD) Submissions via ESG
- Labeling Strategy and Target Product Profiles
- Licensing Services
- CMC Strategy and Authoring
- Advertising and Promotional Material Review/OPDP Submissions
- Pharmacovigilance Services