Services/Solutions CLINICAL DIAGNOSTICS CLINICAL PHARMA SCIENCES - - PowerPoint PPT Presentation

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Services/Solutions CLINICAL DIAGNOSTICS CLINICAL PHARMA SCIENCES - - PowerPoint PPT Presentation

Feb 27, 2024 360 likes •560 views

1 Services/Solutions CLINICAL DIAGNOSTICS CLINICAL PHARMA SCIENCES SERVICES & BIOMARKERS TECHNOLOGIES SERVICES API services Pharmaceutical Internal diagnostic Clinical Packaging Interactive response development

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SLIDE 1

1

Services/Solutions

  • Clinical Packaging
  • Distribution
  • Storage
  • Blinding
  • Commercial drug

procurement

  • Supply chain

management

PHARMA SERVICES CLINICAL TECHNOLOGIES DIAGNOSTICS & BIOMARKERS CLINICAL SERVICES SCIENCES

  • Interactive response

technology (IRT)

  • Electronic patient

reported outcomes

  • Bio statistical

services

  • Pharmaceutical

development Services

  • Commercial

manufacturing

  • Commercial

Packaging

  • Product launch,

distribution and

  • ther commercial

services

  • API services
  • Chemical

development

  • Analytical services
  • Solid state services
  • Biocatalysis
  • Peptides
  • Internal diagnostic

development

  • Biomarker

discovery

  • Companion

diagnostics development

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SLIDE 2

2

Services/Solutions

SCIENCES

  • API services
  • Chemical

development

  • Analytical services
  • Solid state services
  • Biocatalysis
  • Peptides
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SLIDE 3

3

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SLIDE 4

4

Peptide Capabilities

Non-GMP custom synthesis GMP manufacture Analytical support Pre- formulation Radiolabelling

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SLIDE 5

5

Chemistry capabilities

Plant GMP Kilolab nonGMP Lab nonGMP

Pre-clinical Early Phase Late Phase Commercial

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SLIDE 6

6

Chemistry capabilities

Plant GMP Kilolab nonGMP Lab nonGMP

Pre-clinical Early Phase Late Phase Commercial

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SLIDE 7

7

Chemistry capabilities

Plant GMP Kilolab nonGMP Lab nonGMP

Pre-clinical Early Phase Late Phase Commercial

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SLIDE 8

8

Solid State Services

Drug substance Drug Product Solid State

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SLIDE 9

9

Analytical labs at both UK and US sites

Analytical services

Drug substance Standalone Drug product

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SLIDE 10

10

Services/Solutions

  • Clinical Packaging
  • Distribution
  • Storage
  • Blinding
  • Commercial drug

procurement

  • Supply chain

management

PHARMA SERVICES CLINICAL TECHNOLOGIES DIAGNOSTICS & BIOMARKERS CLINICAL SERVICES SCIENCES

  • Interactive response

technology (IRT)

  • Electronic patient

reported outcomes

  • Bio statistical

services

  • Pharmaceutical

development Services

  • Commercial

manufacturing

  • Commercial

Packaging

  • Product launch,

distribution and

  • ther commercial

services

  • API services
  • Chemical

development

  • Analytical services
  • Solid state services
  • Biocatalysis
  • Peptides
  • Internal diagnostic

development

  • Biomarker

discovery

  • Companion

diagnostics development

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SLIDE 11

11

Services/Solutions

PHARMA SERVICES

  • Pharmaceutical

development Services

  • Commercial

manufacturing

  • Commercial

Packaging

  • Product launch,

distribution and

  • ther commercial

services

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SLIDE 12

12

Pharmaceutical Development Services

90-100 Analytical Staff 40 Formulation Staff 20 Project Management Staff

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SLIDE 13

13

  • Development of solid oral dose presentations
  • Manufacturing of prototype:
  • Blends and Granulates
  • Tablets
  • Formulated Capsules and Drug in Capsule
  • Powder in Sachet
  • API in bottle & oral liquid formulations
  • Clinical supply phase I (First in Man Trials)
  • First in man trials in health patients
  • Small batch GMP manufacture
  • Shipment to trial site or client

Early Stage Development

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14

  • Development of immediate release oral dose formulations
  • Tablets, minitabs and sublingual tablets
  • Capsules
  • Powders for sachet
  • Development of modified release oral dose formulations
  • Swellable matrix
  • Delayed release coatings
  • Permeable coatings
  • Coated pellets
  • Enteric coated Tablets and pellets
  • Clinical Supply for Phase IIa/IIb
  • Larger trials looking a dose tolerability in healthy patients
  • Larger batch manufacture

Scale-up Development

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SLIDE 15

15

  • Further formulation development, scale up, & process

investigations

  • Clinical Supply for Phase III and Registration Batches
  • Very large multisite trials looking at effectiveness of treatment
  • Large batch manufacture (> 1 million dosage units)
  • 1st Commercial batches manufacture

Early Stage Development

Later Stage Development

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16

Dry Blending

  • Up to 2,500Kg

Fluid Bed Drying

  • Up to 250Kg

Compression

  • Up to 300,000

tablets/hr

Encapsulation

  • Up to 100,000

capsules/hr

Coating

  • Up to 300Kg

Commercial Solid Oral Dose Manufacturing

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SLIDE 17

17

Niche /

  • rphan drugs:
  • 5k vials / annum

Standard commercial supply:

  • 500Kg blend =

10-20 million tablets per batch

Large scale commercial supply:

  • >400 million

sachets / annum

Commercial Solid Oral Dose Manufacturing

  • 55 Commercial clients
  • Processing 75 commercial products
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18

Process Equipment Capacity

Compression ~ 6.2 billion tablets Encapsulation ~ 1 billion capsules Blister packaging ~ 565 million blisters Bottle packaging ~ 52 million bottles Sachet packaging ~ 1 billion sachets Stickpack ~ 10 million stickpacks Wallet packaging ~ 41 million wallets Vial / ampoule labelling ~ 146 million units Syringe labelling ~ 20 million units

Commercial Solid Oral Dose Packaging

*24 / 7, 45wks p.a.

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SLIDE 19

19

Commercial Product Launch

Pre-submission Submission Commercial Supply

  • QP Declaration &

Site of Release

  • Packaging Design
  • Artwork
  • Shipment

Validation

  • EU Import Testing
  • Product Ordering
  • Serialization
  • Product

Distribution to Pharmacy