Slide Decks - Pharma - Probiotics

Our Services

LyoTech AB is a privately owned consulting company that offers qualified consultants with extensive knowledge in pharmaceuticals and biotechnology. We are a staffing and consulting company that offer highly skilled consultants to cover temporary work loads or to drive longer projects and act as expert help. We offer consultants in, for example, the following areas:

• Project management for all types of pharmaceuticals industry related issues (with or without project management models)
• We work with companies in start-up and established biotech.
• Development of a biotechnological drugs, especially by lyophilization
• Manufacturing knowledge, from lab to manufacturing scale (We do not produce drugs ourselves, we are not a CMO)
• Review documentation related to biotechnological manufacturing (PAT, Process control, QA)
• Help your company to choose and communicate with a contract manufacturing partner (öka er beställarkompetens!)
• Product development and process design
• Continous product improvements
• Aseptic technology and microbiology
• Cryobiology, including formulation and lyophilization of probiotics and cells

QbD and PAT

Quality by Design (QbD) and Process Analytical Technology (PAT) are systems for designing, analyzing, and controlling manufacturing processes based on understanding of the scientific and engineering principals involved and identification of the variables which affect product quality. PAT is consistent with the current FDA belief that quality cannot be tested into products, but should be built-in by design.

The desired state of manufacturing is that:

• Product quality and performance are ensured through the design of effective and efficient manufacturing processes – processes are robust but still optimized!
• Product and process specifications are based on a mechanistic understanding of how formulation and process factors affect the product
• Quality assurance is continuous and real time
• Risk-based regulatory approaches recognize both the level of scientific understanding and the capability of process control related to product quality and performance
  

The primary goal of PAT is to provide processes which consistently generate products of predetermined quality.

Citation from Inspection guidelines from FDA

"Scale-up for the lyophilized product requires a knowledge of the many variables that may have an effect on the product. Some of the variables would include freezing rate and temperature ramping rate. As with the scale-up of other drug products, there should be a development report that discusses the process and logic for the cycle. Probably more so than any other product, scale-up of the lyophilization cycle is very difficult."
(Ref. http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074909.htm)

Statistics on lyo TRENDS