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Biotechnology Principles in Practice®

Biotechnology - Honeyman Group...pharmaceutical manufacturer newly introducing biotechnology. The course considers the range of bio-pharmaceutical products produced, from gene therapy

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Page 1: Biotechnology - Honeyman Group...pharmaceutical manufacturer newly introducing biotechnology. The course considers the range of bio-pharmaceutical products produced, from gene therapy

Biotechnology

Principles in Practice®

Page 2: Biotechnology - Honeyman Group...pharmaceutical manufacturer newly introducing biotechnology. The course considers the range of bio-pharmaceutical products produced, from gene therapy

2

Overview

This course provides a general overview of

biotechnology for those introducing bio-

pharma processes as a start-up manufacturer

or as an established traditional

pharmaceutical manufacturer newly

introducing biotechnology.

The course considers the range of bio-

pharmaceutical products produced, from

gene therapy to monoclonal antibodies, new

clinical trials and scale-up to manufacture.

Introducing regulations and guidelines, we will

also look at what makes biotechnology

different from traditional pharmaceutical

manufacturing, upstream and downstream,

from cell culture processing to purification

methods and separation technologies.

BIOTECHNOLOGY

PRINCIPLES IN PRACTICE®

To gain an understanding of the different types of biotechnology processes

Current and future GMP requirements for biotechnology

Typical product lifecycle phases and regulatory requirements

Steps involved in the manufacture of clinical batches including scale up, product characterisation, and control of process inputs and outputs

How the product can influence facility design and the use of disposable technologies

Differences between the production of a variety of cell substrates e.g. mammalian, bacterial, viral, and plant cell products

Upstream processing including cell culture, fermentation, harvest

Downstream processing including typical purification techniques

Analytical techniques employed to verify final product purity

Fill Finish activities, storage and distribution of product

Principles of process and equipment validation

Course Objectives & Learning Outcomes

Who Should Attend?

Ideal for anyone new to the

industry or processes, as well as

being a good refresher for those

more experienced individuals.

The course is suitable for

different functional groups within

the organisation including:

Operations, Quality Assurance,

QP’s Engineering, and

Validation.

2 DAYS

Click for full details

Page 3: Biotechnology - Honeyman Group...pharmaceutical manufacturer newly introducing biotechnology. The course considers the range of bio-pharmaceutical products produced, from gene therapy

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BIOTECHNOLOGY

PRINCIPLES IN PRACTICE®

Course Programme

Day One

cGMP in Biotechnology, Regulations and

Standards, Biotech Products, Licensing,

Development, Clinical Batches, Scale-up,

Raw Materials, Control of Plant, Animal, Viral

and Bacterial Derived Products. Facility

Structure and Organisation for Biotech

Production, Disposable Technology.

Day Two

Upstream Processing: Crude Biotech

Products Prior to Purification, Downstream

Processing: Production, Primary and

Secondary Purification Requirements,

Techniques and In-process Activities.

Analytical Techniques: Absence of Viruses,

DNA and Plasmid Confirmation, Purity and

Stability, Final Product Purity and Definition.

Fill-finish and Storage/Distribution:

Formulation, Fill/Finish, Final Containers,

Controls Required, Storage and Distribution

of Final Product, Including Hospital or Clinic

Requirements. Validation: Processes,

Equipment, Virus Filtration, IQ/OQ/PQ.

All courses can be booked online:

Cleanrooms: Principles in Practice®

Pharmaceutical Water Systems

Microbiology for Non-Microbiologists

Sterile Product Manufacture

Cleaning Validation

Pharmaceutical Sterilisation

Microbial Risk Management In

Cleanroom Operations

Biotechnology: Principles in Practice®

"Very good overview of

Biotech, exactly what I

needed to put into context

what we are planning for

our new R&D

facility”

CEO,

EirGen Pharma

Page 4: Biotechnology - Honeyman Group...pharmaceutical manufacturer newly introducing biotechnology. The course considers the range of bio-pharmaceutical products produced, from gene therapy

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Honeyman Group Limited

UK OPERATIONS CENTRE & HEAD OFFICE

Harmire Enterprise Park

Harmire Road

Barnard Castle

County Durham

DL12 8BN

United Kingdom

+44 (0) 1833 690101

Honeyman Group Limited

IRELAND OPERATIONS CENTRE

Old Airport Road

Santry

Dublin 9

D09 HP96

Ireland

+353 (0) 15563488

www.honeymangroup.com

Proud winners of:

V1.5