1. The presentation describes the steps for performing a successful technology transfer in the pharmaceutical industry, including feasibility studies, scale-up, exhibit batches, stability studies, and process validation batches.
2. A key part of the technology transfer is developing a technology transfer plan that describes the items and contents being transferred along with detailed procedures and a transfer schedule.
3. Successful technology transfers require effective communication, overcoming challenges through risk assessment, and commitment between the transferring and receiving parties.
NEW ERA OF DRUG PRODUCT: OPPORTUNITIES AND CHALLENGESganpat420
Abstract
Introduction
Global pharmaceutical industry
Indian pharmaceutical industry
Indian Pharmaceutical Market
Opportunities
Challenges
Conclusion
References
Equipment used in pharmaceuticals dosage form manufacturing need to observe continuous qualification to monitor its performance and Concept of URS ,DQ, IQ,OQ,PQ,MQ...
NEW ERA OF DRUG PRODUCT: OPPORTUNITIES AND CHALLENGESganpat420
Abstract
Introduction
Global pharmaceutical industry
Indian pharmaceutical industry
Indian Pharmaceutical Market
Opportunities
Challenges
Conclusion
References
Equipment used in pharmaceuticals dosage form manufacturing need to observe continuous qualification to monitor its performance and Concept of URS ,DQ, IQ,OQ,PQ,MQ...
Manufacturing Control Systems. J R Controls provides control systems for the manufacturing industry. A typical control system will monitor the progress of parts through the manufacturing and finishing process.
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
ANALYSIS OF RAW MATERIALS, FINISHED PRODUCTS, PACKAGING MATERIALS, IPQC, CPCS...Khadeeja6
RAW MATERIALS
It is basically the chemical ingredients of a process. starting material, in production of final product.
FINISHED PRODUCTS
Marketable product, transportable pack, salable pack
PACKAGING MATERIAL
Providing presentation, protection, identification, information, containment, convenience compliance, integrity and stability for a product during storage, transportation display and until it is consumed or throughout its shelf life.
IPQC
Providing accurate, specific and definite description of the procedures to be employed from the receipt of raw materials to the release of the finished dosage form.
CPCSEA GUIDELINES
Role of CPCSEA is to monitor animal experiments through ethics committees set up in institutions (IAEC)
CPCSEA Nominee -important link between CPCSEA and IAEC
IAEC scrutinize all project proposals for experimentation on animals.
The validity of IAEC is for 3 years.
Manufacturing Control Systems. J R Controls provides control systems for the manufacturing industry. A typical control system will monitor the progress of parts through the manufacturing and finishing process.
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
ANALYSIS OF RAW MATERIALS, FINISHED PRODUCTS, PACKAGING MATERIALS, IPQC, CPCS...Khadeeja6
RAW MATERIALS
It is basically the chemical ingredients of a process. starting material, in production of final product.
FINISHED PRODUCTS
Marketable product, transportable pack, salable pack
PACKAGING MATERIAL
Providing presentation, protection, identification, information, containment, convenience compliance, integrity and stability for a product during storage, transportation display and until it is consumed or throughout its shelf life.
IPQC
Providing accurate, specific and definite description of the procedures to be employed from the receipt of raw materials to the release of the finished dosage form.
CPCSEA GUIDELINES
Role of CPCSEA is to monitor animal experiments through ethics committees set up in institutions (IAEC)
CPCSEA Nominee -important link between CPCSEA and IAEC
IAEC scrutinize all project proposals for experimentation on animals.
The validity of IAEC is for 3 years.
PILOT PLANT SCALE- UP TECHNIQUE
Plant, Pilot Plant, Scale-up, Objective, Significance, Steps in scale up, General considerations, Master Manufacturing Procedures, GMP consideration.
Technology Transfer and Scale-up in Pharmaceutical IndustryPranjalWagh1
Transfer of technology is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites”.
In Pharmaceutical Industry, technology transfer refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to full scale commercialization.
It is basically divided into three phases - Research Phase, Development Phase and Production Phase. The presentation elaborates on the technology transfer taking place in production phase. Production phase mainly concerns with validation studies and scale-up.
Validation studies such as performance qualification, cleaning validation and process validation is carried out by R&D department.
Scale-up involves the use of results obtained from lab studies for designing prototype of a product and pilot plant process, constructing pilot plant and further using pilot plant data for full-scale commercialization.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
A brief introduction of validation concept, its scope, advantage. Types of validation, stages of validation, Consideration in principle of validation. Prerequisites of validation, validation protocol, process validation, strategy of process validation of solid dosage form, validation report.
Analytical method validation.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
1. Technology transfer plan &
exhibit
Presented by- Akshay Prakash Nehe
Final year B pharmacy, AVCOP Sangamner
Sem -7 Roll no. 52
2. Technology transfer
Technology transfer is very common
in pharmaceutical manufacturing
but is often taken for granted,
which can led to production
problems and increased costs. This
presentation describes various
steps for performing a successful
technology transfer
3. Transfer of technology
TOT- A logical procedure that controls the transfer of
an established process together with its
documentation of professional expertise to site
capable of reproducing the process and its support
functions to a predetermined level of performance
Ref no. 2
4. Flowchart of technology transfer in pharmaceutical
industry
Technology
developer
Technology receiving site
Feasibility studies
Scale-up
Exhibit batches
Stability studies
Process validation batches
Production batches
Ref no. 5
5. Technology transfer plan
• The TT plan is to describe items & contents of technology to be
transferred, and detailed procedures of individual transfer &
transfer schedule establish judgment criteria for the completion of
the transfer.
• The transferring party should prepare the plan before the
implementation of the transfer & reach an agreement on its
contents with the transferred party
• The Report- Both transferring & transferred parties should
document the TT report
• The exhibit- After taking scale-up batches of product,
manufacturing of exhibit batches takes place. In case of exhibit
bathes sizes are increased along with equipment & their processes
• This is done for filing purpose in regulatory agencies
Ref no. 6
6. Tech transfer documentation steps
Tech transfer
chapter/
proposal
Tech transfer
package
Gap
analysis/ Risk
assessment
Tech transfer
plan
• 1st
documentatio
n step
• Purpose- to
provide a
general
framework for
a tech transfer
& details its
scope
• Should include
description of
teams,
stakeholders,
changes
• Tech transfer’s
success
criteria
The tech
transfer
package should
contain as
much
information as
necessary to
ensure that the
receiving unit
can
successfully
complete the
tech transfer
on time and
within budget
Implementing
a risk
assessment
strategy and
mitigating
those risks will
bring a
robustness to
the transfer
process &
ultimately
prepare it for
validation
Detail execution
of every
important steps
& various
activities
7. Need of technology transfer
• The developer should not be financially sound to require
discovered drug to the whole development because it includes
various steps. In such cases, the collaboration of the developer with
a corporation is needed so the invention could reach to the
market.
• If demand rises for the product then with collaboration within
developer & producing units to induce reciprocally benefitted.
- Points with respect to actual technology or process developer.
Importance of Technology Transfer
• It leads to the economic expansion of pharmaceutical industry influencing
the economic performance of the nation
• It leads to collaboration of science and business which may result in the
introduction of a new drug or health tool to the market
• It is critical process which results in transferring the scientific findings of
the research labs to be available to the commercial units
Ref no. 3
8. Technology Transfer Team
QA
personnel’s
Engineering
personnel
Production
personnel
QC
personnel
QA
personnel
Researchers
• Controlling
temp, pressure
of particular
area
• Calibration
status of
machines &
equipment
Key persons
To make a bridge between
research technologist &
manufacturing unit
• Cross verify instructions
provided by QA personnel’s
• Confirm capacity &
capability of manufacturing
unit
• Setting up testing procedures &
testing specifications
• Validating methods with QA
personnel
• Check & update equipment status
• Quality testing of formulation, post
manufacturing
Perform final review
including
• Equipment
qualification
• Testing
procedures
• Conducting
validation
• Stability studies
• Release of
formulation to
commercializati
on
Getting ready general info
regarding formulation within
kind of written format -
Dossier
Ref no. 4
9. Technology Transfer protocol
• The TT protocol should list the intended sequential stages of the transfer.
The protocol should include;
• Objective;
• Scope;
• Key personnel & their responsibilities;
• A parallel comparison of materials methods & equipment;
• The transfer stages with documented evidence that each critical stage has
been satisfactorily accomplished before the next commences;
• Identification of critical control points;
• Experimental design & acceptance criteria for analytical methods
• Info on trial production batches, qualification batches & process
validation;
• Change control for any process deviation encountered;
• Assessment of end product;
• Arrangements for keeping retention samples of active ingredients,
intermediates and finished products & info on ref substances where
applicable.
• Conclusion, including signed-off approval by project manager.
Ref no. 2
10. Planned transfer activities
• Pilot batches
i. To perform functionality characterization of the active ingredient & critical
excipients
ii. Manufacturing of small pilot batches to confirm feasibility of product using
API & excipients that receiving unit should using.
• Stability batch
i. Based on recommendation of technical report, company manufacture
stability batch to issue manufacturing/packaging protocol, batch reports as
well as stability protocol
ii. Evaluate & confirm critical process parameters & implement in-process
testing controls during stability batch
• Scale up
i. Scale up refers to rise within batch size of the product
ii. Product generated at this stage to access qualification & determine whether
a new tooling or packaging configuration is required or not
• Other studies
i. Perform a process validation, cleaning validation/validation, bulk holding
time, and packaging validation studies
• A report generated by this studies is needed for filing to restrictive agencies.
Ref no. 1
11. Examples side-by-side process comparison
Sending unit Receiving unit
• Pre-blend
Screen excipient A & B through a #12
mesh screen using a Sweco screener.
Blend both for 5 minutes in a 10-cubic-
foot V-blender.
• Blending
Screen excipients C & D and API through
a #12 mesh screen using a Sweco
screener. Add Excipients C, D, and pre-
blend between two equal parts of API.
Mix for 10 minutes in a 60-cubic-foot V-
blender with intensifier bar operating
• Compression
Compress tablets on a Korsch XL400
tablet press at 42-50 rpm (88,200-
105)tablets per hour. Tablet core is a 3/8-
inch round, flat, beveled tablet with a
“C” logo embossed on one side and
“250” on the reverse
• Pre-blend
Order of addition, hand versus
automated mixing and screening,
screen size, type and size of
equipment, mixing time
• Blending
For each blending step: order of
addition, ingredient quantities,
screen size, mixing time, mixing
speed.
• Compression
Model and make of tablet press,
compression, speed range,
description of logo on both sides.
Ref no. 1
12. Example of initial risk management
Item Level of change Risk Risk mitigation
Active ingredients Major Will use different
supplier of directly
compressible active
ingredients
granulation
Tested lots from three
suppliers for chemical
& physical properties.
Will conduct pilot
plant studies.
Excipients Minor Will use the same
suppliers
Sources were already
qualified at receiving
site.
Composition/formulat
ion
Minor Change to % of
lubricant used within
SUPAC limits
Will monitor sticking
issues during pilot
plant.
Batch size Minor RS will run a similar
batch size to that of
the sending site
within EWV
Will perform blend-
time studies on pilot
& scale up batches.
Major equipment Moderate Moving from a high
shear blender to a V-
blender
Will perform-/-
batches to confirm
the uniformity of final
blend
13. Item Level of change Risk Risk mitigate
In-process controls Minor Will maintain same
or more stringent in-
process controls
Will confirm in-
process controls in
pilot and scale-up
studies.
Analytical test
methods – Raw
materials and
finished products
None No changes planned
or will use USP
methods
Will verify all the
compendial methods.
Will transfer finished
products.
Finished product
specifications
None No changes planned Will use the same
release specifications
Stability
Primary packaging
components
None
Moderate
No changes planned
Planning to change
the bottle supplier.
Will use the same
type of resin but
from different
supplier
Will use the same
stability
specifications
Will perform
accelerated & long-
term stability studies
on pilot study
batches
Ref no, 1
14. TT agencies in India
• Asian & Pacific center for transfer of technology (APCTT)
• National Research Development corporation (NRDC)
• Technology information, Forecasting and assessment Council
(TIFAC)
• Biotech Consortium India Limited (BCIL)
• Technology Bureau for Small Enterprises(TBSE)
• Small Industries Development Bank of India (SIDBI)
Ref no. 2
15. Success of technology transfer “C”
Communication
Efficient & effective communication
Certainty
Successful TT includes increased
certainty & decreased risks
Challenges
Overcome them to establish well TT
with risk assessments
Capacity
Enhancing that TT that supports the
sustainable development thus
strengthening capacity for TT
Commitment
Good commitment to
overcome challenges
Ref no. 3
16. Barriers of technology transfer
The basic challenges faces by the organization while
transferring the technology can broadly be defined as
• Economic factors
Poor business administration, lack of business agreement,
lack of pre risk management
• Technical factors
The difference in the infrastructure of research lab and
manufacturing unit leads to technical issues
• Miscellaneous factors
Inadequate funding in imp areas like research centers leads to
incompetent results
• Labour issues
In pharma sector highly skilled and experienced persons are
required , lack in their no. may results in low production
Ref no. 4
17. Successful TT example
• Eli Lily has entered in technology transfer agreement with Shasun
chemicals & Drugs for the manufacturing of Anti TB drug CYCLOSERINE
produced by Shasun to meet Eli Lily global demand
Conclusion
• A tech transfer plan is a living document that captures all activities &
changes & risk involved in a technology transfer, A valuable tool that a
project manager or a technical lead maintains from the project inception
up to the completion of all activities
• TT can be considered successful if a receiving unit can routinely reproduce
the transferred product, process or method against a predefined set of
specifications.
• Technology transfer provides an opportunity to reduce cost on drug
discovery & development thus major pharmaceutical companies look for
technology transfer opportunity as it reduces risk, cost , & rate of failure
Ref no. 6
18. Reference
1. Technology transfer, by Anthony grenier, Copyright @CSE publishing
March 2019 Tablet & capsules
2. Study material by Dr. N. Patra BP 702 T. Industrial pharmacy II
3. Technology transfer in pharmaceutical industry; transfer of process from
development to commercialization : IJPSR (2013), vol. 4, issue 5 review article
by Rahul dogra, Rajeev garg & Prakash jadhav
4. TT: An overview process, review article by K. Pandey, H. Joshi.., published
@IJCPR in 2018
5. Technology transfer; case studies from real world, @PDA Israel, by Ofer
Dublinsky in March 2019
6. Technology transfer in pharmaceutical industry by K. Amneet, Sharma o. p
R&D dept in morepen labs @IJCPR in 2013