Nitto Avecia Pharma Services Parenteral Manufacturing

March 5th, 2019 by aveciapharma

Lab worker in a clean room wearing protective gear

Nitto Avecia Pharma Services is a FDA inspected cGMP contract development and manufacturing organization supporting the pharmaceutical and biopharmaceutical industries from early phase through post-market life cycle management. With a state-of-the-art facility, experienced staff, and robust quality infrastructure, Avecia Pharma delivers client-centric solutions in a timely manner.

Nitto Avecia Pharma Services has a state-of-the-art facility capable of handling an array of unique products. The facility is complemented by a well-trained and knowledgeable staff with a proven track record of developing processes for some of the most sensitive and complex products. Avecia Pharma’s manufacturing department produces batches at the highest quality as the team works hand-in-hand with the Formulation and Quality teams as well as other resources to develop the documentation, process flow, material list and equipment recipes needed in the successful transfer from a lab environment into manufacturing.

Nitto Avecia Pharma Services has received licenses for Pharmaceutical Drug and Device Manufacturing by the California Food and Drug Branch in addition to receiving an ISO 13485 certificate for contract manufacturing and formulation of pharmaceutical, biopharmaceutical, and medical device products.

Complete Package of Services

  • Toxicology, clinical trial and commercial manufacturing
  • cGMP aseptic filling/lyo (2-100mL vials)
  • Custom hand fills
  • Process assessment and validation
  • Lyophilization
  • Terminal sterilization
  • Inert gas purge and overlay
  • Documentation preparation (including CMC submission)
  • Formulation/product development
  • Analytical development
  • Biopharmaceutical development
  • CMC analytical testing

Leading-Edge Facility

  • Three GMP manufacturing suites
  • Passive RABS filling line
  • Dedicated air-handling in each suite
  • Formulation lab and pilot suite
  • Video viewing of production
  • Flexible and scalable
  • No seasonal uncertainties

Expertise in Multiple Dosage Forms

  • Liquid
  • Lyophilized
  • Emulsions
  • Suspensions
  • Liposome

State-of-the-Art Equipment

  • Filling Machine with 100% vial weight check capability
  • Water for Injection (WFI) generation and storage
  • Pure Steam generation and distribution
  • Lyophilizer/Freeze dryer
  • Depyrogenation oven

Posted in: Pharmaceutical Online

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