Services of CreoSalus®

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cgmp

Aseptic Manufacturing

  • Veterinary controlled release injectable peptide delivery
  • Aseptic fill and terminal sterilization experience

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aseptic

cGMP Custom Peptides

  • Personalized peptides “sequence to needle…”
  • Process development
  • High throughput/on-time history
  • INAD/clinical trial compliance

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research

Research & Development

  • Custom peptide drug discovery
  • State of the art laboratory
  • Analytical method development
  • Analytical method validation/transfer
  • cGMP trained staff

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A LIST OF A LA CARTE PRODUCTS & SERVICES WE OFFER

PROCESSES

CreoSalus handles all aspects of process development for parenteral dosage forms, including peptides, solutions, suspensions and lyophilized products. We have mechanical and chemical engineers to optimize your process to reduce line loss, increase efficiency and mitigate risk. We have additional qualified third-party support to meet all needs.

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VIAL FILLING OF LIQUIDS

Our Chase Logeman filling line can support clinical and commercial cGMP sterile liquid vial filling from small scale through small commercial batches.

We also have experience for small volume hand fill glove box technology for small volume personalized medicine.

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TERMINAL STERILIZATION

CreoSalus has 20 years of experience with suspension handling and Gamma irradiation terminal sterilization partnered with Steris Isomedics. To provide optimal sterility in the pharmaceutical manufacturing process, we have experience and the capability of terminally sterilizing vials ranging from 2mL to 100mL.

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LABELING AND PACKAGING

CreoSalus has partnered with tertiary packaging services currently with Multi-Packaging Solutions. Whether products are for clinical trials or the commercial market, we can assist in the identification of cost-effective and efficient integrated labeling/packaging and distribution solutions for you. For clinical studies, we provide custom packaging and labeling guided by our expert project managers and quality and regulatory affairs teams.

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STORAGE AND SHIPPING

CreoSalus’s GMP operations support pharmaceutical packaging, returns, quarantine and controlled substances. Our secure warehousing and processes mitigate risks to product safety, identity, strength, purity and quality.
To avoid temperature excursions that can compromise product integrity, we offer validated temperature monitoring and GMP warehouse management for your materials in a variety of conditions, including:
• Ambient storage: +15°C to +30°C
• Refrigerated storage: +2°C to +8°C
• Frozen storage: -15°C to -25°C
• Ultra-low frozen storage: -70°C to -90°C
• Our team is experienced in shipping to all areas both domestically and internationally.

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MANUFACTURING

With years of experiences, CreoSalus is a leading player in the high throughput cGMP peptide production field, providing customers with high quality products, fast turnaround time and regulatory compliance.

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