9ix- tech transfer - laura blade - galenicum

U n i v e r s i t y j o i n s

I n d u s t r y

T E C H T R A N S F E R �1 1 t h M a r c h , 2 0 1 5

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?






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?






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?






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�


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


Tech Transfer�


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


Tech Transfer�


FORMULA and DEFINITION OF THE PROCESS


Tech Transfer�


Kneading conditions:

Chopper: 7500 rpm Impeller: 150 rpm

Binding solution adition time: 4 min

Granulation time: 2min Chopper: 1500 rpm Impeller : 150 rpm


Tech Transfer�


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%


Tech Transfer�


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


Tech Transfer�


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


Tech Transfer�


Coating conditions: Pan speed: 5-7 rpm

Flow rate: 300 ml/min Inlet temperature air: 60ºC

Outlet temperature air: 50ºC Product temperature: 45ºC


Tech Transfer�


SUBMIT THE VARIATION TO THE HEALTH AUTORITHIES

APPROVAL FROM HEALTH AUTORITHIES: CMO2 MANUFACTURER, PACKAGER, CONTROLER AND RELEASER

ROUTINE PRODUCTION FOR ALL CUSTOMERS


Tech Transfer�

INDEX

-  WHO AM I?






PERSONALITY PROFILE


Tech Transfer�

WHAT DO YOU NEED TO WORK IN A TECH TRANSFER DPT?

  EDUCATION /EXPERIENCE and PERSONALITY PROFILE-SKILLS


Tech Transfer�


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…)


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!!!


Tech Transfer�

Thank you and Good Luck!!!�

9ix- tech transfer - laura blade - galenicum

Documents