Research at an industrial perspective

1. Rajesh L. Dumpala
(B.Pharm, M. Pharm.) PhD. ( Pursuing)
Research Scientist,
Alembic Research Centre. Vadodara
M. +919016119159
E.Mail:-rdumpala64@gmail.com
1
RESEARCH AT AN INDUSTRIAL PERSPECTIVE

2. 2
Contents
• Objective
• Brief details of Product development Flow
• Stages of Product Development
• Why Technology Transfer
• When does Technology Transfer occur ?
• Function of Technology Transfer

3. Objective:
The objective is to know the product development cycle in brief &
different stages/departments involved from product identification to
development & commercialization.
There are various department & various stages involved in this and are
elaborated further.
Product Flow

4. R&D
DQA F&D
T.T
IPR ADL Clinical
B.E
P.M
(Project
Management)
Research & Development
4

5. 5
Product Identification Business Development (Intl. Marketing)
Product Development
Formulation Development & Analytical
Development Laboratory
Development
Trials/Scaleup/PO/EB
Batches
F&D,Technology Transfer, Production, QA
& QC
Prevalidation /Scale up
Validation Batches
Revalidation & Trouble
Shooting
Technology Transfer, Production, QC & QA
Product Flow

6. Stages of Product Development
6

7. Business Development (Intl. Marketing)
Identify the molecule/products which is valuable with respect
volume & revenue added in annual grid to Formulation
development dept. to develop generic version of the innovator
product available in the particular market.
Stage 1 :

8. Innovator products details review, literature review,
Stage 2 :
Formulation development of any products involved following stages
Literature Search:
Product development activity is initiated with the Literature search & Patent survey.
Various Books & web site shall be referred but not limited to Physicians Desk Reference,
Merck Index, USP, CAS, BP, Ph.EUR, Martindale, BPC, Vidal and Florey. Internet
search, Orange book, Rx list, FOI (Freedom of information), and Other Product
information, Patent Search, Orange book patents and Reference listed drug product in
orange book. Details about the patent search shall be provided by Patent Cell on request
of Product development scientist.

9. Stages of Product Development
Stage 3 : Active Sourcing
- Evaluate at least two suppliers fully.
- Request for the samples, COA and Specifications.
Preformulation Studies
This first learning phase is known as preformulation
It can be defined as an investigation of physical and chemical properties of a drug substance - alone and
or when combined with excipients.
A Preformulation study involves
API Characterization (Description, Melting Point,Solubility, PSD, Bulk Density, Flow Properties,
Hygroscopicity, Effect of particle size on dissolution, Polymorphism (XRD, DSC, IR) Assay, Stressed
Analysis, Impurity profile, Optical rotation, Enantiomeric purity, residual solvents, Degradants (if any) and
Solubility & Stability at different pH.) Selection of Excipients, Drug excipients Compatibility studies –
Compatibility mixture ratios
9

10. Stages of Product Development
Stage 4 : Active Evaluation
- DMF availability
- Compliance with USP monograph
- Impurity profile and stability
- Potential Polymorphic forms
- Commitment for physical specifications
Stage 5 : Active Purchasing
Stage 6 : Active Testing
10

11. Stage 7 : Innovator's Product Purchasing
Stage 8 : Innovator's Product Testing
- Evaluate physical parameters such as
- Tablet shape
- Tablet color
- Pack sizes containers materials
- Closure types ; cotton and desiccants
- Innovator Physical / Chemical Testing such as
- Weight / Thickness / Hardness
- LOD
- Friability
- Disintegration
- Dissolution
- Related Substance
Stages of Product Development
11

12. Stage 9 : Innovator's Product Testing (Continue)
- Microscopic observation such as
- Particle size
- Crystal shape
- Identification of specific Excipient
Stage 10 : Bulk Active Testing
- Physical characterization of bulk batch
- Polymorphism
- Particle size distribution
- Bulk density & Tapped density
- Microscopic observation
Stages of Product Development
12

13. Stage 11 : Bulk Active Testing (Continue)
- Chemical characterization
- Assay
- Stressed Analysis
- Impurity profile
- Optical rotation
- O.V.I. Testing
Stage 12 : Excipients Selection
- Pre-Formulation Studies
Stage 13 : Container Closure System
- Manufacturers and suppliers
- Material composition
- Requirement of cotton and desiccants
- Manufacturer's DMF numbers for all component parts
Stages of Product Development
13

14. Stage 14 : Selection of Manufacturing Process
- Granulation
- Wet Granulation
- Dry Granulation
- Dry Mixing
- Slugging Method
- Blending Time Optimization
- Evaluation of Physical Properties of Granules
- Flow properties
- Bulk Density & Tap Density
- Particle-size distribution
- Compressibility
- Hausner’s Ratio
Stages of Product Development
14

15. Stage 15 : Selection of Manufacturing Process (Continue)
- Evaluation Physical Properties of Compressed Tablets
- Weight
- Thickness
- Hardness
- LOD
- Friability
- Disintegration
Stage 16 : Bulk Active Purchased
Stage 17 : Analytical Evaluation
- Dissolution - in USP medium (Multipoint profiles) and other relevant media versus Innovator's product
- Validation of analytical package i.e. Assay; Dissolution, Content Uniformity completed prior to Process Qualification
Stages of Product Development
15

16. Stage 18 : Process Optimization
Stage 19 : Analytical Evaluation
Stage 20 : Scale Up
Stage 21 : Process Qualification - Pre-Exhibit / PO Batch
Stage 22 : Pivotal Production - Exhibit / Submission Batch
Stage 23 : Bio Study Results Evaluation
Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological
equivalence of two proprietary preparations of a drug. If two products are said to
be bioequivalent it means that they would be expected to be, for all intents and purposes, the
same.
Stages of Product Development
16

17. 17
Stages of Product Development Cont…
Stage 24 : Pre-Submission Auditing
Stage 25 : Submission
Stage 26 : Process Validation
Process Validation is defined as the collection and evaluation of data,
from the process design stage throughout production, which
establishes scientific evidence that a process is capable of
consistently delivering quality products.
Stage 27 : Process Re-validation

18. Why Technology Transfer
18

19. 19

20. When does Technology
Transfer occur ?
● Idea to Discovery Lab
● Discovery Lab to Development Lab
● Development Lab to Kilo Lab
● Lab to Pilot Plant
● Kilo Lab to Pilot Plant
● Pilot Plant to Semi-works (other pilot plant)
● Pilot Plant/ Semi-works to Manufacturing
● Manufacturing to Manufacturing
20

21. Function of Technology Transfer
◙ Documentation
- Product Development Report (PDR)
- Master Formula Card (MFC)
- Sampling Protocol
- Master Packaging Card (MPC)
- Standard Test Procedure (STP)
- Raw Material Inprocess, Finished & Shelf Life Specification
◙ Execution of Scale Up, PO / Pre-Exhibit, Exhibit, Validation Batches
◙ Cost Reduction
◙ Contract Manufacturing
◙ Manufacturing Site Transfer
◙ Commercial Trouble Shooting
◙ SUPAC Level Changes (Annual Reportable, CBE & PAS) 21

22. FLOW OF FORMULATION & DEVELOPMENT
AT
RESEARCH CENTRE
22

23. Pharma Industry
23

24. Upcoming IT industry providing services
to
Pharma industry
24

25. Doctors give life to human and we pharmacists give life to medicines.
Questions ?
25

26. Thank YouIf you salute your duties, No need to salute anybody
If you don’t salute your duties, You have to salute everybody.
26