Manufacturing

Micelle BioPharma is continuously expanding its US and global strategic partnerships. As a US-based, fully-integrated, specialty pharmaceutical company, Micelle BioPharma can provide assistance with your project whether you are looking for Soft Gel Manufacturing, contract Soft Gel Manufacturing, leveraging Micelle BioPharma’s platform Advanced Lipid Technologies® to clinically improve your lipophilic drug candidate, expanding your current drug portfolio through In-Licensing Agreements or seeking to establish or expand the US marketing and distribution of your approved drugs.

SOFTGEL DRUG MANUFACTURING

Micelle BioPharma is one of the very few manufacturing facilities in the US with an isolated softgel manufacturing suite for drug products with containment needs. We offer you the opportunity to develop and manufacture superior drug products with an experienced team focused on safety and quality on a timeline that beats the competition. Our suite has been audited by the FDA for manufacturing of products containing hormones, and we are the only FDA-inspected drug manufacturing facility in the United States that can manufacture and package your softgel product into bottles at the same facility.

Isolated Suite Features

  • Single-pass HEPA filtered air for both inlet and exhaust air
  • Separate rooms for gowning, dispensing/compounding, encapsulation, printing, polishing and inspection
  • High speed softgel
  • encapsulation capable of manufacturing up to 30,000,000 capsules a month. All waste water is collected and managed separately.

Micelle BioPharma has extensive experience manufacturing softgel hormone drug products containing the estradiol, progesterone, and for oral administration or as vaginal suppositories. We are well qualified to safely handle and manufacture hormone-containing products, as well as other potent compounds requiring containment. Micelle BioPharma offers complete end-to-end services from analytical development and validation, pre-formulation, deformulation, and formulation development to cGMP manufacturing and quality control testing of clinical and commercial pharmaceutical products, as well as stability storage and testing at our facility in Riviera Beach, Florida.

With our state-of-the-art isolated suite now on-line capable of producing 30,000,000 capsules a month, Micelle BioPharma has the capacity and availability to meet most project needs. If you are ready to manufacture a softgel product requiring an isolated suite, we can be your turnkey solution. Instead of waiting in line to access the overwhelmed capacity of other vendors, contact us to secure your slot to advance your project today!

SOFTGEL DRUG MANUFACTURING

As drug discovery yields more complex lipophilic drug compounds to treat modern diseases, the pharmaceutical industry has a pressing need to adapt. When typical tableting formulations are no longer possible due to the physicochemical properties of the active pharmaceutical ingredient (API), innovation in encapsulation is required. Micelle BioPharma is among the leaders at the forefront of this advancement in formulation technology as one of only 3 approved contract-manufacturing facilities for softgel drug products in the United States. With our current softgel lines, which comprises our state-of-the art isolated suite as well as standard manufacturing area, we can manufacture in excess of 90,000,000 capsules a month.

Softgels Enhance Solubility

Micellle understands the challenges poor solubility of novel drug molecules pose to the development process. Softgels paired with the right excipient mixture allow for an API that might otherwise be insoluble and impermeable to the gastrointestinal tract to be administered orally while having optimum exposure. We have mastered a variety of cutting edge formulation techniques utilizing softgels to mediate drug bioavailability issues. With our Advanced Lipid Technology (ALT®), we have pioneered a new tool to overcome the Food Effect and First Pass Effect of drug absorption. In fact, we can license our proprietary ALT platform in the development of your product or work with you to design a dosage form that meets your target drug profile.

Micelle BioPharma Softgel Services

We are a team of innovators, dedicated to maintaining the highest standards in drug development and manufacturing. At our facility in Riviera Beach, Florida, we can take your compound from early development to commercialization, providing expert guidance through a quality-by-design approach.

  • Analytical development and validation
  • Pre-formulation, deformulation, and formulation development of softgel
  • Fills and shells cGMP manufacturing and quality control testing
  • Stability storage and testing
  • Pilot, exhibit, clinical and commercial scale batches

Furthermore, we are the only FDA-inspected drug manufacturing facility in the United States that can manufacture and package your softgel product into bottles at the same facility.

Micelle BioPharma’s recently expanded capacity now produces up to 30 million softgels in our isolated suite per month and 60 million softgels in our standard manufacturing area. We have the availability to handle most capacity needs, so let us help you bring your softgel product to market. Avoid waiting in line to access the overwhelmed capacity of other vendors, and contact us to secure your slot to advance your project today!