STERILE & NON-STERILE GLOVE BOXES AND CONTAINMENT SYSTEMS FOR HPAPI PROCESSING

•  WEIGHING / HPAPI SYNTHESIS

•  CONJUGATION & PURIFICATION

•  LYOPHILIZATION AND FILLING

•  DRYING & COMPRESSION

•  MULTI-TASK SYSTEMS


ADC Manufacturing

Manufacturing antibody-drug conjugates (ADCs) poses unique challenges at each stage of processing—from initial HPAPI manipulation all the way to patient testing. ADC manufacturing facilities require major initial investment and extensive operator training. The weighing and dissolution of HPAPI, considered the most hazardous step, must be carried out in a negative pressure enclosure before it is transferred into a sterile environment. Once the HPAPI is weighed and dissolved in to a solution, it is slightly safer to handle—though it still must be channeled through a series of engineering controls, often spread over the space of several labs.


Cytotoxic Glovebox Workstation

Flow Sciences’ glovebox workstations have long been lauded for personnel and product protection, as well as exceeding containment performance and targets when dealing with even the most highly potent APIs. The Glovebox Workstation offers sub-nanogram containment, which is critical for ADC applications given the potency of materials. Decontamination has always been a concern for labs working on ADC— this rigid wall solution allows for companies to utilize better equipment that won’t be destroyed after a single use, and let manufacturers integrate enhanced washdown/cleaning protocols to satisfy increasing scrutiny on proper safe handling of conjugates. The Glovebox Workstation is the first step in an end-to-end process for research and development markets that are growing exponentially.

Standard Features

• DESIGNED FOR HPAPI MANIPULATION
• ISO 5 OR BETTER INTERIOR CLEANLINESS
• NEGATIVE PRESSURE HEPA FILTRATION
• GLASS OR ACRYLIC VIEWING PANELS
• MANY BASE (WORKTOP) OPTIONS
• STANDARD 4’, 5’, AND 6’ WIDTHS
• 6-7 PLACE BALANCE STABILITY
• UNIVERSAL SIDE PORT / TRANSFER PORT
• WITH OR WITHOUT STAND

Optional Features

• CUSTOM SIZING AND CONFIGURATION
• STAINLESS STEEL BASE OR SUPERSTRUCTURE
• CLEAN IN PLACE (CIP) & WASHDOWN
• JOINING OF OTHER CONTAINMENT SYSTEMS
• VACUUM AND OTHER SERVICE INTEGRATION


CONTAINMENT SOLUTIONS

War Head Synthesis

• Chemical Fume Hoods Connected to Glovebox Workstations for High Potency API handling to solution


Conjugation & Purification - Non-Sterile

Externally Vented Oversized Enclosures for Lab Equipment Including:
• Laser Particle Analysis
• HPLC Flash Chromatography
• Laser Diffraction
• Other Lab Process Equipment


Sterile Conjugation

The Microsphere provides a physical barrier between product and operator which
eliminates the need for a cleanroom while conjugating. During ADC processing, this is
where the antibody is purified to remove process-related contaminants (unconjugated
toxin and residual solvent).
• ISO 4 in the main chamber & ISO 5 in the antechamber
• Cost efficient unidirectional positive pressure C.A.I.
• Recovery rate of less than 60 seconds
• Ease of use, ergonomic, easy to install, maintain, and operate
• Optional TSPs : Total Service Plans that include certification, SOPs, and essentials


Lyophilization & Filling - Non-Sterile

• Benchtop Lyophilizer Containment Systems with Iris Ports
• Glovebox Workstations conjoined with Lyophilizers and Biological Safety Cabinets to introduce trays from freeze dryer directly into containment
• Other Lab Process Equipment


Aseptic Formulation

The Chemosphere allows for additional processing since ADCs for human clinical
applications must be manufactured in an aseptic biological environment that operates
according to cGMP. The formulation of the ADC takes place at this step.
• ISO Class 4 in the main chamber & ISO Class 5 in the antechamber
• Unidirectional and negative pressure C.A.C.I
• Alarms and interlocks for prevention and safety
• Fast recovery rate (less than 1 minute)
• Ease of use, ergonomic, easy to install, maintain, and operate
• Optional TSPs : Total Service Plans that include certification, SOPs, and essentials


Drying & Compression

• Safe localized containment for ovens and other lab equipment
• Integration ovens or through the sidewall or rear of the enclosure


Aseptic Filling / Sterility Testing

The Isotech Isophere Sterility Tester allows for decontamination of the ADC which utilizing
H202, which overcomes the problems associated with conventional surface disinfection
validation. It is safer while being less expensive than cleanroom alternatives.
• ISO 4 unidirectional airflow
• Eliminates the risk of high start-up costs, extended deadlines, and possible contamination
• Complete product/operator protection
• Small critical area: increased SAL
• Minimal energy requirements
• Filling equipment integration, interface with lyophilizers, autoclaves and DHS
• Decontamination with H2O2 generator
• IQ/OQ validation: documentation & execution


Multi-Task Systems - Conjoined Systems

• Integrations of various equipment types in a contained process line
• Various options of enclosure styles for connecting and joining


CONTACT US

Contact Us Below to Speak to a Containment Expert about Your Application and Get a Recommendation or Quote

  • What is being done inside of the enclosure? What type of material (powder, liquid, gas, nuisance odor) is being worked with? How does the material enter and exit the enclosure system? etc...
  • What type of filtration is required? Single HEPA, Dual HEPA, Carbon, House Exhaust, etc... What is the required OEL (Occupational Exposure Limit) for the process, or any other details about containment goals? What is the quantity of powder or liquid, task duration, composition of powder, etc...?
  • What equipment is being worked with? What is the equipment model, size, scope, function, and any other information that will affect the design of the enclosure, including movement, heat output, etc...? *State the specific equipment make and model if available*
  • Drop files here or
    • Are there any additional notes or information that should be considered? Are there any special design requirements?