Smart Manufacturing Helps Your Business

HELPING YOUR INDUSTRY

Why Attwill Medical?

  • Facilities and process control systems.
  • Cost effective and time efficient.
  • A focus on you.
WHY ATTWILL
Attwill Medical Solutions is ISO 9001:2000 and ISO 13485:2003 Certified

[ BACK ]

Pharmaceutical

It's one thing to provide fully cGMP compliant facilities, equipment and procedures to our pharmaceutical partners. It's another to be able to apply them in a smart, strategic way throughout the bulk lyophilization process. Working closely with you, we're adept at the development, scale-up and implementation of a fully cGMP compliant process all the way from formulation through lyophilization to product packaging.

  • US FDA registered drug manufacturing facility
  • cGMP compliant facilities, equipment and procedures
  • ISO 7 (Class 10,000) temperature and humidity controlled processing suites
  • Lyophilization batch sizes from grams to tons
  • Formulation and lyophilization of APIs (Active Pharmaceutical Ingredients)
  • Lyophilization cycle development, scale-up and optimization
  • Flexible and compliant bulk packaging (grams to multi-kg)
  • cGMP compliant receiving, storage and shipping of materials, packaging and product
  • Strong working relationships with manufacturers of APIs and with contract manufacturers of finished pharmaceutical products.
  • Compliance consulting

From Start-up to Success: Working with a Pharmaceutical Partner

The stakes are extremely high for a pharmaceutical start-up company, especially one bringing its first drug candidate to clinical trial. Our client was relying heavily on Anteco Pharma to work with their R&D staff in developing, scaling-up and implementing a cGMP compliant lyophilization process for a novel enzyme derived from tissue culture.

We helped our client by providing the experimental design and development of an optimized lyophilization process. This included documentation of the design and development; preparation of cGMP compliant manufacturing documents, and validation of the lyophilization process. We also coordinated our efforts with the client's new quality organization.

The process in place, we proceeded with the cGMP manufacture and packaging of the client's clinical material. We also provided the coordination and documentation of cGMP compliant storage and shipping of the clinical products and analytical samples.

Our client was off and running and our combined efforts resulted in a drug candidate with early positive results in phase 1 clinical trials.