We specialize in manufacturing long-acting parenteral products (including microparticles and injectable solid implants), hydrophobic drug salts, and liposomes.

Our highly qualified and experienced team has manufactured materials for Phase I—III clinical trials for more than 15 years. Our knowledge of parenteral manufacturing operations and equipment allows us to design systems that reproducibly yield low bioburden and low particulate product. Manufacturing unit operations are designed and constructed by Brookwood’s team of experienced process engineers. We have successfully conducted many technology transfers of client processes into our facilities. Our process engineers and chemists can also scale your bench process to a robust, regulatory compliant process. We can manufacture aseptic product or make dosage forms that are terminally sterilized.

Brookwood’s facilities include:

  • 650 sq. ft. of classified area within each suite
  • Class 100 to 100,000
  • Temperature and RH controlled
  • Quarantine and storage areas for each suite
  • Qualified utilities
  • Qualified environmental monitoring
  • Qualified refrigerators and freezers

Additionally, Brookwood’s wholly owned subsidiary, Lakeshore Biomaterials, has a 500 sq. ft. of clean-room space (class 10,000, temperature and RH controlled) available for biomaterial contract manufacturing.

Our manufacturing experience includes:

  • Microencapsulation — injectable microparticles, nanoparticles, liposomes
  • Extrusion — injectable solid implants
  • Synthesis of injectable drug particles
  • Synthesis of biomaterials

Pharmaceutical Processing and Clinical Trial Manufacturing

Staff:

  • Project managers
  • Chemical and mechanical engineers
  • Chemists

Scale:

  • Microencapsulation - Grams to 7.5 kg
  • Synthesis - Grams to 75 kg

Equipment Selection:

  • Appropriate accuracy
  • Functionality
  • Sanitary design/cleanability
  • Materials of construction
  • Scalability
  • Cycle time considerations

Measurement:

  • Gas - Linear mass flow meters
  • Fluids - Corriolis effect flow meters
  • Mass - Load cells, balances
  • Temperature - RTDs, thermocouples

Control and Automation:

  • Primary - Single loop controllers
  • Secondary - Dual loop controllers
  • Jacket temperature control
  • Process fluid flow control
  • Equipment cycle control

Process Monitoring:

  • Integrated process monitoring
  • Flexible hub and socket design
  • Provides hard data and electronic data

Applications:

  • Microencapsulation
  • Extrusion
  • Chemical synthesis

Clincial Trial Material Manufacturing

Qualifications:

  • Trained and experienced staff
  • Documentation systems in place
  • Quality systems in place
  • Qualified and inspected facilities

Experience:

  • Phase I-III
  • Approximately 300 lots of CT material

Regulatory Considerations:

  • Sanitary design
  • FDA acceptable materials of construction
  • Raw materials
  • Equipment qualification
  • Process qualification
  • Cleaning qualification
  • Documentation

Pre-Production Activities :

Components

  • Vendor qualification (4-0009)
  • Receipt of components (4-0010)
  • Test specification development (4-0014)
  • Testing (6-0004)
  • QCU release (4-0005)

Equipment

  • Qualification and calibration (4-0022)
  • Cleaning (3-0004)

Personnel

  • Training (1-0007)
  • Growing qualification (2-0008)

Facility

  • Cleaning (3-0001/3-0005)
  • Air sampling (3-0003)
  • Microbial testing (3-0002)
  • Facility release (4-0012)

Documents

  • Test methods (6-0003)
  • MBPR development, review, approval (4-0015/4-0019)
  • Order for CT material (4-0016)

Production:

  • BPR ticket issuance (1-0014)
  • Label issuance (4-0013)
  • QCU clearance (4-0008)
  • In process samples (6-0004)

Post Production:

  • Fill/Finish ticket issuance (1-0014)
  • Labeling (4-0013)
  • Release testing (4-0014)
  • QCU audit (4-0007)
  • COA issuance (6-0001)

Facilities:

  • Three cleanroom suites that can be operated independently
  • Purpose built for parenteral formulations (low bioburden/particulates)
  • Class A aseptic areas using glove boxes and class 100 hoods
  • Class 100 to Class 100,000 (ISO 5 to ISO 8)
  • Supporting utilities

 

[Image] Clean room

Typical Brookwood cleanroom

[Image] Clean room