Cell & Gene

Ease of integration in aseptic isolator system manufactured by Tema Sinergie. Filling and capping All-in-one cGMP compliant filling and capping machine. Ease of integration Ease of integration in any aseptic isolator system manufactured by Tema Sinergie Safety Interlock system with integrated light barriers which interrupts the automatic process for operator safety. Data management Batch filling report automatically generated at the end of the production phase.

Guest Column | July 8, 2026 By Mark F. Witcher, Ph.D., biopharma operations subject matter expert CDMOs are a vital part of the pharmaceutical and medical device industries. Building, executing, and maintaining an effective sponsor/CDMO working relationship is critical to developing, commercializing, and manufacturing many important therapies and products.

The Dispensing Isolator is a GMP Class 2 containment enclosure designed for the most challenging containment levels during manipulations of potentially hazardous compounds for production activities. The isolator system is equipped with a turbulent air flow system, and constantly guarantees a negative pressure gradient between the chambers and the lab environment. The high air quality of the isolated environment is assured by High Efficiency Particulate Air (HEPA H14) filters.

A contamination control strategy is only as strong as its execution on the manufacturing floor. Even when validation is robust, routine cleaning and disinfection often introduce risk through inconsistent manual technique, incomplete residue removal, and day-to-day deviations that can weaken cleanroom control and expose facilities to Annex 1 scrutiny. Closing that gap requires more than documented procedures.

Tema Sinergie AB-PTC Series is a comprehensive range of Pass Through Box (cGMP Class A/ISO 5) designed for pharmaceutical companies that require an isolated environment for external bio-decontamination of materials prior to their transfer into classified environments.

CAP-IS (Compact Aseptic Processing Isolator System) is a cGMP Class A/ISO 5 isolation system, specifically designed for pharmaceutical production laboratories. The system is engineered to provide top-tier aseptic performance even in confined spaces: within just 2.5 meters, it integrates a process chamber connected to a transfer chamber and a built-in VPHP bio-decontamination system. Fully compatible with the new Glove Leak Test System – AGLTS 2.

The Aseptic Filling Isolator is a custom-designed cGMP Class A/ISO 5 isolator system specifically designed for batch scale pharmaceutical production of injectable products for pre-clinical and clinical trial studies. This specific AP-IS Series isolator has been designed to meet mandatory user requirements and fully integrates AseptiFill, our automatic vials filling and capping machine.

Designed for pharmaceutical quality control and microbiology laboratories. Tema Sinergie QA Microbiology Isolators (ST-IS Series) provides a comprehensive range of aseptic isolators, fully compliant with the strictest cGMP and international regulations, specifically designed for Sterility Testing and pharmaceutical quality control activities.

Continuous bioprocessing promises greater efficiency, but linking upstream and downstream unit operations into one coordinated workflow remains a major hurdle. While many intensification efforts focus on individual steps, stronger insight comes from seeing how multiple operations work together in practice.

Antibody-drug conjugates are reshaping cancer treatment, but their success depends on more than targeted biology alone. Upstream bioprocessing now plays a defining role in whether ADC programs scale efficiently, maintain product quality, and stay on track for clinical and commercial milestones.