Commercial Manufacturing

commercial-manufacturing

A Purpose-Built Facility for Complex Drug Products

While CMO market capacity is adequate for mainstream products, there is a lack of manufacturing capacity for the rapidly growing sub-segment of complex drug products. Such a facility requires not only purpose-built infrastructure, but also a highly specialized staff. To fill this gap, we have established commercial production for complex drug products, leveraging our decades of knowhow as a leading product developer and clinical stage manufacturer. The facility is separate but adjacent to the existing development and clinical trial manufacturing site, offering customers a seamless flow from development through manufacturing – a one stop shop. Our customer-focused staff thrives in a dynamic, highly technical environment. Our team and our facility are ideally sized for complex drug product manufacturing, so you can rest assured that your drug product will get the care and focus it needs to succeed.

Facility and Equipment

Processing Rooms

  • 6,000 ft2 Commercial Space
  • 500 ft2 Grade C Flexible Space / Processing Room
  • 320 ft2 Grade A Filling Room
  • Grade A Lyophilizer Loading / Unloading Room

Foundational Equipment

  • Bausch Model 515 Filler with In-Line Weight Checker (30 - 60 vials/minute) with Restricted Access Barrier System (RABS) Isolation Technology
  • Syringe Filler
  • Millrock 120 ft2 Lyophilizer (Capacity: 25,000 10 mL / 65,000 2 mL vials)

Utilities

  • Water for Injection (WFI)
  • Clean Steam
  • Clean Compressed Air
  • Clean Compressed Nitrogen
  • Process Waste System

Dedicated QC Laboratory

  • State of the Art Equipment
  • Release and Stability Testing
  • ICH-Compliant Stability Program
  • Raw Materials and Component Testing
  • Environmental Testing

Wide Breadth of Technical Capabilities

Our commercial facility possesses a wide range of capabilities built around complex drug product development and manufacturing, including:

  • Aseptic Production: Our facility contains ISO 5 Filling Suites for both clinical and commercial production. This includes our Grade A RABS aseptic filling suite, which can process vials, ophthalmic bottles, syringes, cartridges, and dual chamber devices.
  • Lyophilization: We have a 120 ft2 lyophilizer that builds upon our existing R&D and clinical lyophilization capability (2 R&D and 2 small-scale clinical lyophilizers). Our commercial lyophilizer is supported with both Clean-In-Place and Steam-In-Place capabilities allowing for aseptic processing.
  • Particle Size Reduction: Particle Sciences is a leader in nanomilling (wet, dry, and aseptic), microfluidization, and spray drying. We are presently the only for-hire organization that can perform nanomilling under aseptic conditions at a commercial scale using commercially-available or proprietary mills.
  • Unique Polymer Processing: Particle Sciences specializes in drug/device combination product development and manufacturing. Our polymer processing capabilities include hot melt extrusion, co-extrusion, and injection molding. Particle Sciences has also established preferred relationships with the world’s leading polymer suppliers, ensuring a seamless path to commercialization.
  • Non-Traditional Dosage Forms: Our passion for complex drug product development means that we can handle just about project, including dosage forms like nanoparticles, resorbable microspheres, films/patches, and lipid-based systems.

An Analytical and Quality Control Team You Can Trust

We have built a strong Quality team comprised of Quality Control (QC) and Quality Assurance (QA) that works closely with our development and manufacturing staff to ensure your product is manufactured successfully and to the highest quality standards. Our dedication to complex drug products means that our QC team possess core strengths in analytical method development, physical characterization, forced degradation, commercial validation, and long-term stability testing. Particle Sciences’ staff has extensive experience with a variety of APIs (small and large molecules) and can develop methods to evaluate properties such as assay and related substances, in vitro release, and encapsulation efficiency.

Stability testing and a well-designed ICH-compliant stability program are critical elements of a rigorous drug formulation and development plan, and our facility is equipped with state-of-the-art temperature and humidity controlled/monitored chambers for accelerated and long-term stability testing, including standard ICH conditions, controlled low humidity for semi-permeable containers, and photostability. Finally, our floating quality assurance (QA) group establishes continuity across our organization. Our QA team is integrated into everything we do, and they possess the experience and mindset to deal with the unique challenges of complex drug product manufacturing.