Client Support Services Offered by Contract Manufacturers

Client Support Services Offered by Contract Manufacturers

By providing a professional, reliable and high quality service to its clients, Luina Bio ticks all the boxes when it comes to choosing a contract manufacturer

 

The pharmaceutical products (like drugs or biologics) used in therapeutics for human diseases and disorders must be safe, effective and of good quality. Current Good Manufacturing Practices (cGMP) is designed to ensure that manufacturers are able to consistently produce products that meet the quality, purity and strength appropriate to their intended use.

Technical expertise is critical when deciding which contract development and manufacturing organisation (CDMO) to partner with. However, other key variables of importance that also distinguish the best CDMOs are timelines, efficiency, flexibility and organizational expertise.

With over 20 years’ experience in the development and production of recombinant proteins and vaccines, human and veterinary products and live biotherapeutics, Luina Bio is a leading Australian CDMO. It offers professional services to biopharmaceutical and biotech companies, research institutes, veterinary drug companies and universities.

At its manufacturing facility in Brisbane, the company conducts microbial aerobic and anaerobic fermentation, technical transfer, cell banking, process development and validation, analytical development, and cGMP production and stability studies for clients in America, Asia, Australia and Europe.

The company has undertaken a wealth of diverse and challenging projects, a selection of which include:

  • Recombinant protein from coli for a phase 3 trial in the US under IND
  • Production of anaerobic BSL-2 Live Biotherapeutics for a Phase 1 trial in the US
  • Recombinant protein from coli conjugated to a carbohydrate for a phase 2 in the US under IND and phase 2/3 trial in the EU;
  • Fermentation sourced semisynthetic carbohydrate for a phase 3 clinical trial in Asia;
  • Whole-cell killed vaccine for a phase 2 trial in the US and Australia under IND.

Luina Bio also offers a range of client support services that complement its cGMP manufacturing capabilities. These include:

  • Process Development
  • Analytical Development
  • Process validation
  • Project management
  • Manufacturing advice
  • GMP document preparation
  • CMC or dossier package development
  • Stability studies

In addition to its manufacturing and project management expertise, Luina Bio offers validation and regulatory advice capabilities. It can prepare all necessary cGMP documents as well as the chemistry, manufacturing and control dossiers. And can also offer stability studies both for Master cell banks, drug product and drug substance.

Luina Bio’s approach is to be open, honest and up-front when things go wrong. By utilizing its change control system early in the manufacturing phase, the company can agree with the customer to change or modify a production process and justify that change to the authority once production has begun.

It also has a corrective and preventive action system to solve and address issues concerning any nonconformities that may be encountered and prevent them from happening again in the

 

Categories: Biomanufacturing, Quality

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