GGALENICUM HEALTH 2
Tech Transfer�
INDEX
- WHO AM I?
- ACTIVITIES IN TECH TRANSFER DEPARTMENT
- BRIEF DESCRIPTION OF CHRONOLOGIC STEPS FOR A TRANSFER
- EXAMPLE OF A TRANSFER
- WHAT DO YOU NEED TO WORK IN A TECH TRANSFER DPT?
EDUCATION/ PROFESSIONAL EXPERIENCE
PERSONALITY PROFILE
GGALENICUM HEALTH 3
Tech Transfer�
WHO AM I?
- Laura Bladé
- 36 years old
- Pharmacist (UB) / Master Pharmaceutical Industry/ Different trainings trough my professional experience
- Experience in more than 13 years at the Pharmaceutical Industry (from 2002): Menarini, Almirall, Merck Serono and currently at Galenicum Health
- Future plans??? Learn…and learn…and learn…!!!
GGALENICUM HEALTH 4
Tech Transfer�
INDEX
- WHO AM I?
- ACTIVITIES IN TECH TRANSFER DEPARTMENT
- BRIEF DESCRIPTION OF CHRONOLOGIC STEPS FOR A TRANSFER
- EXAMPLE OF A TRANSFER
- WHAT DO YOU NEED TO WORK IN A TECH TRANSFER DPT?
EDUCATION/ PROFESSIONAL EXPERIENCE
PERSONALITY PROFILE
GGALENICUM HEALTH 5
Tech Transfer�ACTIVITIES IN TECH TRANSFER DEPARTMENT
Scale-up products to CMO
Transfer of products between 2 sites (same or different company)
Optimization of processes
Homologation of new materials (excipients, active ingredients, packaging materials)
Follow up of products in the market: changes in the manufacturing process, stability studies
TEAM WORK
Interaction with other departments: R&D / Production Area
Quality control / Analytical transfer Quality Assurance Regulatory Affairs
Supply Commercial/Marketing
GGALENICUM HEALTH 6
Tech Transfer�
INDEX
- WHO AM I?
- ACTIVITIES IN TECH TRANSFER DEPARTMENT
- BRIEF DESCRIPTION OF CHRONOLOGIC STEPS FOR A TRANSFER
- EXAMPLE OF A TRANSFER
- WHAT DO YOU NEED TO WORK IN A TECH TRANSFER DPT?
EDUCATION/ PROFESSIONAL EXPERIENCE
PERSONALITY PROFILE
GGALENICUM HEALTH 7
Tech Transfer�
BRIEF DESCRIPTION OF CHRONOLOGIC STEPS FOR A TRANSFER
1. CMO SEARCH TO PRODUCE A PRODUCT
2. NDA SIGNATURE BETWEEN COMPANIES
3. SHARING TECHNICAL INFORMATION FOR THE QUOTATION/EVALUATION COST AND DECISION
4. SUPPLY AGREEMENT/SHARING DETAILED TECHNICAL INFORMATION
5. GAP ANALYSIS AND CONTINUOUS FOLLOW UP BY TC’S, SCHEDULES, VISITS…
6. ANALYTICAL AND PROCESS TRANSFER BETWEEN COMPANIES
7. TRIALS/FEASIBILITY BATCHES/VALIDATION BATCHES
8. ANALYSIS OF BATCHES
9. PREPARATION OF DOCUMENTS TO SUBMIT VARIATIONS TO THE HEALTH AUTORITIES
10. SUBMIT VARIATIONS/APPROVAL FROM HEALTH AUTORITIES
11. ROUTINE PRODUCTION (FOLLOW UP, EVALUATION OF CHANGES IN MANUFACTURING PROCESS)
GGALENICUM HEALTH 8
Tech Transfer�
INDEX
- WHO AM I?
- ACTIVITIES IN TECH TRANSFER DEPARTMENT
- BRIEF DESCRIPTION OF CHRONOLOGIC STEPS FOR A TRANSFER
- EXAMPLE OF A TRANSFER
- WHAT DO YOU NEED TO WORK IN A TECH TRANSFER DPT?
EDUCATION/ PROFESSIONAL EXPERIENCE
PERSONALITY PROFILE
GGALENICUM HEALTH 9
Tech Transfer�
EXAMPLE OF A TRANSFER: ANSUTANIN®
PREVIOUS INFORMATION
- Product in the market for more than 5 years
- Film-coated tablets for Alzheimer illness (by Wet granulation process in HSM)
- Reason of the transfer between CMO1 to CMO2: Economic reason and Supply problems
- CMO1 located in India, CMO2 located in Europe
- Additional difficulty: CMO1 does not know the necessity of the transfer of the product
s
GGALENICUM HEALTH 10
Tech Transfer�
EXAMPLE OF A TRANSFER: ANSUTANIN®
1. Study of all requirements to submit the necessary variations to the Health Autorities
(Ex. Validation protocol and 2 certificates of analysis of 2 industrial batches)
2. Check technical documentation from the Dossier
Main points: Manufacturing and packaging process
Specifications and analytical methods of the raw materials (API and excipients) and packaging materials
Specifications and analytical methods of finished product
Check standards, columns and all kind of analytical material needed for the transfer or the validation
Knowledge of the stability of the product
3. Operational documentation from CMO1 (India) not available
GGALENICUM HEALTH 11
Tech Transfer�
EXAMPLE OF A TRANSFER: ANSUTANIN®
ANALITYCAL ACTIVITIES
- ANALYTICAL TRANSFER FOR API (PREVIOUS STARTING VALIDATION BATCHES): Comparing results between supplier of API and CMO2
- EXCIPIENTS ARE INCLUDED IN Ph. EUR. : VALIDATION IS NOT REQUIERED
- ANALYTICAL TRANSFER FOR FINISHED PRODUCT (before starting production batches): Comparing results between CMO1 and CMO2
MANUFACTURING PROCESS ACTIVITIES
- Pilot batches / Validation batches : MANUFACTURING AND ANALYSIS
GGALENICUM HEALTH 12
Tech Transfer�
EXAMPLE OF A TRANSFER: ANSUTANIN®
FORMULA and DEFINITION OF THE PROCESS
GGALENICUM HEALTH 13
Tech Transfer�
EXAMPLE OF A TRANSFER: ANSUTANIN®
Kneading conditions:
Chopper: 7500 rpm Impeller: 150 rpm
Binding solution adition time: 4 min
Granulation time: 2min Chopper: 1500 rpm Impeller : 150 rpm
GGALENICUM HEALTH 14
Tech Transfer�
EXAMPLE OF A TRANSFER: ANSUTANIN®
Drying conditions: Inlet air temperature: 35ºC
Outlet air temperature: 30ºC Product temperature: 25-35ºC Air flow rate: 3000-5000 m3/h
LOD required at the end of the process: < 1.5%
GGALENICUM HEALTH 15
Tech Transfer�
EXAMPLE OF A TRANSFER: ANSUTANIN®
Blending conditions: 1- Blend of the granulate with diluent:
Speed: 14 rpm Time: 20 min
Number of tumbles: 280 tumbles 2-Blend with Lubricant
Speed: 14 rpm Time: 4 min
Number of tumbles: 56 tumbles
GGALENICUM HEALTH 16
Tech Transfer�
EXAMPLE OF A TRANSFER: ANSUTANIN®
Tabletting conditions: Precompresion force: 2 kN
Main pressure: 18 kN Number of stations: 37 Type of tooling: Euro D
Depth of fill: 12 mm Upper punch penetration: 4 mm
Speed: 150.000 tablets/hour
GGALENICUM HEALTH 17
Tech Transfer�
EXAMPLE OF A TRANSFER: ANSUTANIN®
Coating conditions: Pan speed: 5-7 rpm
Flow rate: 300 ml/min Inlet temperature air: 60ºC
Outlet temperature air: 50ºC Product temperature: 45ºC
GGALENICUM HEALTH 18
Tech Transfer�
EXAMPLE OF A TRANSFER: ANSUTANIN®
SUBMIT THE VARIATION TO THE HEALTH AUTORITHIES
APPROVAL FROM HEALTH AUTORITHIES: CMO2 MANUFACTURER, PACKAGER, CONTROLER AND RELEASER
ROUTINE PRODUCTION FOR ALL CUSTOMERS
GGALENICUM HEALTH 19
Tech Transfer�
INDEX
- WHO AM I?
- ACTIVITIES IN TECH TRANSFER DEPARTMENT
- BRIEF DESCRIPTION OF CHRONOLOGIC STEPS FOR A TRANSFER
- EXAMPLE OF A TRANSFER
- WHAT DO YOU NEED TO WORK IN A TECH TRANSFER DPT?
EDUCATION/ PROFESSIONAL EXPERIENCE
PERSONALITY PROFILE
GGALENICUM HEALTH 20
Tech Transfer�
WHAT DO YOU NEED TO WORK IN A TECH TRANSFER DPT?
EDUCATION /EXPERIENCE and PERSONALITY PROFILE-SKILLS
GGALENICUM HEALTH 21
Tech Transfer�
EDUCATION/ PROFESSIONAL EXPERIENCE
Degree of Pharmacy, Engineering, Chemistry (in general)
Specialization during the degree: trainees in pharma companies, subjects related to the Pharmaceutical industry
Languages (English is a MUST, others are “nice to have”)
Computer skills (Word, Excel, Ppt, Access, Project)
Experience (or not) in Production area, Pharma Tech area, Tech Transfer or Galenical departments
Knowledge in software for Pharma industry (SAP, LIMS, Mango, Documentum, Platon, Navision, Trackwise…)
GGALENICUM HEALTH 22
Tech Transfer�
PERSONALITY PROFILE
- Energetic, dynamic, proactive, persevering, strong, awake, ordered, meticulous person
- Self-sufficient
- Curious: why? When? What? Where?
- Capacity to understand CMO’s, people and problems: empathy
- Ability to relate different ideas and synthesize information
- Prospective view: anticipate at possible problems
- Conviction power and excellent communication skills
- Capacity to take decisions quickly and efficiently
- Management, coordination activities and leadership skills
and the most important thing is: ENJOY YOUR JOB!!!