Lyophilization Technology

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Lyophilization Technology
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
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• Instructor Profile
• Mr. Jerry Dalfors has
  extensive (40 years) of business administration,
  consultative, technical and managerial experience
  in the development and manufacture of highly
  regulated biopharmaceutical products including
  injectables, biologics, medical devices and oral
  dosages. He has held permanent employee,
  temporary employee and company representative
  management positions with a multitude of the
  major pharmaceutical and biotechnology companies
  in the US. He has worked with or assisted more
  than two dozen companies with the establishment
  of controlled document/quality systems, FDA
  briefing and submittal documents, project
  management of several multimillion dollar
  projects including design, start-up and
  validation to assure fast track FDA approval by
  maintaining strict regulatory compliance during
  all phases of engineering, construction,
  commissioning and validation, and has written
  numerous submission documents for product,
  process and facility approval/licensing which
  also required the development of quality systems
  which included customer complaint management,
  deviation management, CAPA and associated site
  wide employee training.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
3

• Description
• Lyophilization cycles consist of
  three phases Freezing, primary drying, and
  secondary drying. Conditions in the dryer are
  varied through the cycle to ensure that the
  resulting product has the desired physical and
  chemical properties and that the required
  stability and sterility is achieved and
  maintained.
• During the freezing phase, the goal is to freeze
  the mobile water of the product. Significant
  super cooling may be encountered, so the product
  temperature may have to be much lower than the
  actual freezing point of the solution before
  freezing occurs. Generating very large frozen
  particles due to the initial freezing process can
  cause the sedimentation rate to go way up causing
  a much longer cycle than effective design of the
  process can accomplish making the process more
  cost effective and higher quality. 

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
4

• Why Should you Attend
• The fundamental principles and
  technology are coupled with practical aspects of
  lyophilization in the training program.
  Principles and concepts presented are later used
  to discuss real world practical applications. The
  long term training sessions include participants
  in development, operations, engineering,
  technical services, quality, validation, and
  regulatory affairs. Brief on-line training
  addresses critical aspects of freeze drying to
  ensure compliance, validation and minimization of
  patient risk based on the development of the
  product proven to have been during the clinical
  trials before the product was transferred into
  commercial scale operations.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
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• Objectives of the Presentation
• The key objectives of the presentation
  are to discuss about
• Essentially a brief discussion about each of the
  Critical Aspects and related affects of Variables
• Lyophilization 101 - Comprehension on each step
  of the Freeze Drying/Lyophilization Process
• Understanding why various steps of the process
  become more advantageous and cost effective
• Sublimation Rate Variability
• Heat Transfer, Loss of Protein Activity
• Freezing Affects on Primary Drying
• Optimization of Primary Drying and Proof of the
  effectiveness of Secondary Drying
• Effects of Freezing Method and Excipients on
  Protein Surface
• Influence of Packing Density and the container
  selection
• Residual Moisture Regulatory Considerations by
  the FDA

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
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• Who can Benefit
• Development, Regulatory and
  Validation individuals attempting to demonstrate
  effective lyophilization that is of consistent
  (meeting current validation statistical
  standards), high quality and minimizing patient
  risk 

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
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• Live Session - How it works
• Username and Password will be sent to you 24
  hours prior to the webinar
• Presentation handouts in pdf formate will be
  mailed to you
• Login to the session using the username and
  password provided to you
• Get answer to your queries through interactive
  QA sessions via chat
• Please let us know your thoughts and views at the
  end of webinar, your valuable feedback will help
  us improve
• Get certification of attendance.

• Recorded Session - How it works
• A link will be provided to you upon purchase of
  the recorded session
• Please click on the link to access the session
• Presentation handouts in pdf formate will be
  mailed to you
• Get certification of attendance.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
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Get Connected

• www.onlinecompliancepanel.com

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com