Manufacturing
Significant US-Based Manufacturing Capacity
For over 15 years, Exela Pharma Sciences has been building its manufacturing operations in the United States to permit the development and cGMP manufacturing process through final Drug Product. From early phase to clinical and commercial manufacturing, we provide integrated drug formulation, analytical, and aseptic and terminally sterilized fill finish solutions that enable life science innovators to develop and deliver successful sterile products to patients in need.
Tech Transfer
Our project management and process development teams are skilled at spotting inconsistencies and ready to help you through a successful Tech Transfer process. Together, we will work hand in hand with your team to transfer your current formulation or manufacturing process to our fill finish facilities.
We will work with you to identify and improve:
- Analytical and microbiological method requirements
- Material requirements
- Manufacturing processes
- Equipment cleaning methodologies
- Container closure integrity strategy
- Labeling and packaging requirements
- Supply chain needs
cGMP Parenteral Drug Product Manufacturing Capabilities
Vial Filling – Medium and High-Speed Automated Vial Filling Equipment
The vial filling equipment provide:
- Dose and volume consistency
- Reduced production costs
- Easier quality control processes
- Rapid scalability
- Minimize shrinkage and loss protection
IV Bags – IV Bag Filling
Intravenous (IV) bags offer a ready-to-use convenience saving precious time for healthcare givers and patients while also eliminating or reducing drug errors and contamination. Exela has IV bag manufacturing capabilities.
Pre-Filled Syringes
The global pre-filled syringe market is driven in part by the rapid growth in COVID-19 vaccines and in anticipation of future viruses for which pre-filled syringes are a suitable drug-delivery mechanism. The benefits of pre-filled syringes are many.
Exela has substantial prefilled syringe capacity to produce millions of units with additional capacity in the near future.
Lyophilization Services
Exela offers lyophilization for sensitive drug products. Our lyophilizer can handle most clinical supplies volumes and small to medium size commercial scale production.
Automated Inspection, Automated Labeling, and Automated Packaging Services
Exela received FDA approval in 2014 for inspection, labeling, packaging, warehousing, and shipping operations. We have a dedicated finishing/packaging facility that is equipped with modern high-speed inspection, labeling, and packaging machines.
Automated Inspection Services
- Exela has both semi-automated and fully automated high-speed vision systems for inspecting vials and syringes. We also employ manual inspection to handle smaller batches.
Automated Labeling Systems
- We have multiple automated high-speed labelers for both vials and syringes.
Automated Packaging Systems
- Automated high-speed Cartoners are used to package finished product.
Aseptic Fill Finish and Terminal Sterilization
At Exela we manufacture sterile, injectable products in our Class 100 (ISO 5) clean room and can also conduct aseptic processing using isolator systems which minimizes the extent of personnel involvement and separates the external cleanroom environment from the aseptic processing line. A very high level of stability can be achieved using isolators for aseptic processing. We maintain dedicated, self-contained cleanrooms for conducting sterile manufacturing and aseptic fill finish processes.
Terminal sterilization at Exela is achieved by using high-capacity autoclaves (water and steam).
Controlled Drug Products – Schedule II-IV in house DEA Capability
Exela is licensed by the Drug Enforcement Agency and the relevant authorities for many states, to handle Schedule II-V drug products. We are equipped with a highly secured DEA vault to store controlled drug substances and drug products. In addition, we have state-of-the-art software systems to support manufacturing and movement of Schedule II-V drug substance and drug products so that we can ensure compliance with the applicable quotas.
Stability Program
Exela understands that a well-designed, ICH-compliant stability program is central to every drug development plan. We offer comprehensive data and stability packages that complement our development and manufacturing services.
Exela has ample storage capacity for the incubation of both semi-permeable and impermeable containers under one roof.
Stability Program services include:
- Wide range of stability conditions available with a variety of chamber sizes
- Large walk-in controlled stability room
- Several stability chambers to conduct accelerated, intermediate and room temperature stability studies including for permeable containers (bags & syringes)
- Customer reviewed and approved stability protocol development
- Stability storage at accelerated and long-term ICH conditions
- Photostability
- Stability table preparation and maintenance
- Sample management capabilities during a study
- In-house stability testing