GMP-compliant cannabinoid based therapeutic actives

GES Monthly Newsletter, Quarter 3 (July – September) 2024

Corporate Strategy Update

In Q3, we closed a Capital Raise for our expansion plans that includes a strategic pathway to maturing into a general pharmaceutical manufacturer:

  1. New site expansion focussed on generic pharmaceutical finished medicines containing cannabinoids
  2. Drug Master File development, submissions, and regulatory approval
  3. Clinical trials
  4. International vertical integration into Germany and the UK
  5. Expanded commercialization of new technologies for our new product development pipeline
  6. Audits to obtain EU GMP Part 1 and Brasilian ANVISA approval

We are excited to share the progress around the developments towards the end of the year.

Staff function August 2024

New Members

We have continued our growth, and as of September 2024, we have a full-time staff of 48 who have committed themselves to GES Labs’ vision. We also welcome new team leaders with years of global pharmaceutical experience, bringing mature growth into our Quality Management System (QMS) as we scale our supply chain to meet our clients’ demands on time and compliantly.

Roxanne Potgieter – Head of Quality

Roxanne joins with 15+ years of pharmaceutical manufacturing expertise. Having experience as Production Manager, Technical Expert, QA Pharmacist, QA Manager, Responsible Pharmacist, and Divisional QA leadership roles. She now leads our quality departments, bringing a strong international experience base to scale our business into the Future. She has worked at global and domestic successful pharmaceutical enterprises including Pharma Dynamics (a subsidiary of Lupin Ltd), Environ, Pharmaceutical Enterprises, NSF-CMi Africa, and ATP Manufacturing.

Monique Julius – Quality Assurance Manager

Monique joins with 15+ years of pharmaceutical manufacturing expertise. Having experience as a Distribution Pharmacist, Regulatory Manager, Responsible Pharmacist, Quality Assurance Executive, and QA Manager roles. She now together with Roxanne, provides QA support, mentorship, and leadership to our QA and QC teams. She has worked at strong pharmaceutical companies such as Barrs Pharmaceuticals, Opus Pharmaceuticals, Environ, The Biovac Institute, Vital Health Foods, and SekPharma.

We have a strong commitment to quality assurance, and we cannot wait to continue building our various custom systems that are quality-based and supply chain-focussed ensuring on-time, compliant delivery of our manufactured products globally.

We also have the following new team members joining us:

  • Saziso Gobeni (QC Team)
  • Kyle Scheepers (Production)
  • Vishal Magan (Engineering Technical Team)
  • Teri-Lee Homes (Production)
  • Tylo Hunter (Engineering Technical Team)

Expansion, & Optimization

As we continue to re-invest in our vision and growth, we completed a successful expansion plan that will allow us to commercialize our research and development pipeline.

To date, we have expanded in the following areas this year, which have been qualified and commercially operational:

More info: https://www.linkedin.com/pulse/exciting-upgrades-geslabs-elevating-manufacturing-capacities-enhanced-iyz9f/

  • Doubled cryo-ethanol extraction capacity
  • Quadrupled our wiped film distillation technologies
  • There is a tenfold increase in our ability to formulate MCT-cannabinoid formulations
Wiped Film Distillation

This expansion and optimization have led to some operational savings from an economies of scale perspective and we decided to pass on those savings into our value chain, giving our partners immediate working capital saving and their current product lines. These enhancements in our operations led to a 25% reduction in our manufacturing costs surrounding our cryo-ethanol production costs.

We are also expanding our business with a new site build. We will employ a two-strategic facility build-out. Our existing facility, GES Labs, will be focused on unlicensed medicine production supporting patients globally where specialized, and personalized medicines have to be considered.

New Product Development

Our research and development department together with our production department has been successful in bringing forward a high-quality, large-scale solventless production line leading to our – ultra full-spectrum medical cannabis products.

More info: https://www.linkedin.com/pulse/pioneering-solventless-production-geslabs-cvjae/

This new product development has led to bringing in new equipment to put together new product categories in:

  • Inhalation cartridges
  • Inhalation concentrate formats
  • Full-spectrum MCT-Rosin-THC oils
  • Pastilles-Rosin
  • Live resin inhalation products
  • THC-A manufacturing and standardized THC API

Our new product development strategy is running full steam ahead, and we expect a highly innovative pipeline, to which our existing partners will thrive in the coming months. Part of our expansion later this year, includes the development of a state-of-the-art research and development dedicated laboratory, fitted with world-class technologies on a pilot scale, ability to commercialize at record time.

Live Rosin R&D Development – Cannabinoids wt%
Live Rosin R&D Development – Terpene wt%
Live Rosin Product as above results

We are committed as always to these values

  • Quality products
  • Innovative solutions
  • High quality of service offering
  • A product offering, that is current, in-demand, and sustainable
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CBD Isolate Natural

Parameters
Specification
Formulation
>98% CBD
Appearance
White crystalline powder
Packaging
1kg HDPE container
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
24-months (stability ongoing)
Extraction
Ethanol
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

Distillate + Strain-Specific Terpenes

Parameters
Specification
Formulation
440mg (0.5ml) or 880mg (1ml) THC distillate + Chemotype terpenes
Appearance
Yellow-gold viscous liquid, solid at room temperature
Packaging
1ml SS316 510-Thread cartridge
0.5ml SS316 510-Thread cartridge
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
18 months (on-going)
Extraction
Cryo-ethanol extraction
Low temperature Decarboxylation to preserve terpenes
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 18 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)
Strains
"Day Blend", "Night Blend", UK Cheese, Blueberry Kush, Black Cherry Punch, Royal Gorilla, Karels Haze, Critical Kush, Creamy Kees, White Lemon, Original Blitz, Sour OG Cheese, Mandarin Cookies, Jungle Pie, Slurricane, Gooseberry Pie

Distillate + Botanical Terpenes

Parameters
Specification
Formulation
440mg (0.5ml) or 880mg (1ml) THC distillate + Botanical terpenes and/or Flavours
Appearance
Yellow-gold viscous liquid, solid at room temperature
Packaging
1ml SS316 510-Thread cartridge
0.5ml SS316 510-Thread cartridge
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
18 months (on-going)
Extraction
Cryo-ethanol extraction
Low temperature Decarboxylation to preserve terpenes
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 18 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)
Options
Blueberry Haze, Grape, Blue Dream, Orange, GG#4 (Live Resin)

Live Rosin Strain Specific

Parameters
Specification
Formulation
375mg (0.5ml) or 750mg (1ml) THC Live Rosin
Appearance
Yellow-gold viscous liquid, solid at room temperature
Packaging
1ml SS316 510-Thread Cartridge
0.5ml SS316 510-Thread Cartridge
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
18 months (on-going)
Extraction
EP-grade water and low temperature pressing, fresh frozen cannabis flower
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 18 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)
Strains
GMO Cookies, Wedding Cake, Guerilla Cookies, Platinum Slurricane, Duraflame, East Coast Sour Diesel, Ice Box, Stawguava, Cheetah Piss, Moonshine Haze

Live Resin Strain Specific

Parameters
Specification
Formulation
440mg (0.5ml) or 880mg (1ml) THC Live Resin
Appearance
Yellow-gold viscous liquid, solid at room temperature
Packaging
1ml All-Ceramic 510-Thread Cartridge
0.5ml All-Ceramic 510-Thread Cartridge
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
18 months (on-going)
Extraction
Low temperature hydrocarbon, fresh frozen cannabis flower
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 18 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)
Strains
Sour Tangie, OG Kush, Apes in Space

Full-Spectrum Decarboxylated Crude Oil

Parameters
Specification
Formulation
>70% THC <2% CBD
Appearance
Dark Amber liquid, solid at room temperature
Packaging
Insert Argon purged. Amber glass bottle 50ml, 500ml and 2.5L. Glass Type III Polypropylene (PE) Cap
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
24-months (stability ongoing)
Extraction
Cryo-ethanol extraction
Low temperature Decarboxylation to preserve terpenes
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)
Strains
Black Cherry Punch (Hybrid-Indica), Blueberry Kush (Indica), Critical Kush (Indica), Creamy Kees (Hybrid-Indica), Royal Go- rilla (Hybrid-Sativa), Karel’s Haze (Hybrid-Sativa), Bafokeng Choice-White Lemon (Hybrid-Sativa), UK Cheese (Sativa), Original Blitz (Indica) | *More strains on request

Broad-Spectrum Distillate

Parameters
Specification
Formulation
>88% THC <2% CBD
Appearance
Clear yellow-gold viscous liquid, solid at room temperature
Packaging
Insert Argon purged. Amber glass bottle 50ml, 500ml and 2.5L. Glass Type III Polypropylene (PE) Cap
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
24-months (stability ongoing)
Extraction
Cryo-ethanol extraction
Low temperature Decarboxylation to preserve terpenes
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)
Strains
Black Cherry Punch (Hybrid-Indica), Blueberry Kush (Indica), Critical Kush (Indica), Creamy Kees (Hybrid-Indica), Royal Go- rilla (Hybrid-Sativa), Karel’s Haze (Hybrid-Sativa), Bafokeng Choice-White Lemon (Hybrid-Sativa), UK Cheese (Sativa), Original Blitz (Indica)| More strains on request

Live Rosin

Parameters
Specification
Formulation
>70% THC <2% CBD
Appearance
Viscous semi-solid at room temperature, yellow-gold
Packaging
Insert Argon purged. Amber glass bottle 5ml, 50ml, 250ml. Glass Type III Polypropylene (PE) Cap
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
24-months (stability ongoing)
Extraction
Low temperature EP-grade water, fresh frozen cannabis
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)
Strains
GMO Cookies, Wedding Cake, Guerilla Cookies, Platinum Slurricane, Duraflame, East Coast Sour Diesel, Ice Box, Stawguava, Cheetah Piss, Moonshine Haze

Live Resin

Parameters
Specification
Formulation
> 85% THC <2% THC
Appearance
Yellow-gold, semi-solid at room temperature
Packaging
Insert Argon purged. Amber glass bottle 50ml, 500ml and 2.5L. Glass Type III Polypropylene (PE) Cap
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
24-months (stability ongoing)
Extraction
Low temperature hydrocarbon, fresh frozen cannabis flower
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)
Strains
Sour Tangie, OG Kush, Apes in Space

D9-THC API (95+%) Natural

Parameters
Specification
Formulation
> 95% THC, minors according to pharmaceutical monograph
Product Type
API
Appearance
Clear viscous liquid, solid at room temperature
Packaging
Insert Argon purged. Amber glass bottle 50ml, 500ml and 2.5L. Glass Type III Polypropylene (PE) Cap
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
12-months
Extraction
Solvent extraction
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 12 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

Sativa Strains*

Karels Haze

THC: 30%

Mandarin Cookies

THC: 27%

Original Blitz

THC: 27%

Jungle Pie

THC: 26%

* More available on request

CBD Dominant

100mg/ml CBD <4mg/ml THC – 30ml
Parameters
Specification
Formulation
Full spectrum CBD extract with pharma grade MCT oil
Product Type
MCT oral formulation
Appearance
Clear to amber liquid at room temperature
Packaging
30ml amber dropper bottle with a child-resistant lid and syringe
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
12-months
Extraction
Cryo-ethanol extraction
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

CBD Dominant

200mg/ml CBD <4mg/ml THC – 30ml
Parameters
Specification
Formulation
Full spectrum CBD extract with pharma grade MCT oil
Product Type
MCT oral formulation
Appearance
Clear to amber liquid at room temperature
Packaging
30ml amber dropper bottle with a child-resistant lid and syringe
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
12-months
Extraction
Cryo-ethanol extraction
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

CBD Dominant

200mg/ml CBD <ND THC – 30ml

Parameters
Specification
Formulation
CBD isolate with pharma grade MCT oil
Product Type
MCT oral formulation
Appearance
Clear to amber liquid at room temperature
Packaging
30ml amber bottle with glass pipette dropper
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
12-months
Extraction
Cryo-ethanol extraction
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

Balanced

15mg/ml CBD – 15mg/ml THC – 30ml
Parameters
Specification
Formulation
Full spectrum THC and CBD extract with pharma grade MCT oil
Product Type
Oral MCT formulation
Appearance
Clear to amber liquid at room temperature
Packaging
30ml amber bottle with child-resistant lid and 1ml syringe
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
12-months
Extraction
Cryo-ethanol extraction
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

Balanced

25mg/ml CBD – 25mg/ml THC – 30ml

Parameters
Specification
Formulation
Full spectrum THC and CBD extract with pharma grade MCT oil
Product Type
Oral MCT formulation
Appearance
Clear to amber liquid at room temperature
Packaging
30ml amber bottle with child-resistant lid and 1ml syringe
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
12-months
Extraction
Cryo-ethanol extraction
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

THC Dominant

<1mg/ml CBD -15mg/ml THC – 50ml

Parameters
Specification
Formulation
Full spectrum THC extract with pharma grade MCT oil
Product Type
Oral MCT formulation
Appearance
Clear viscous liquid, solid a room temperature
Packaging
50ml amber bottle with child-resistant lid and 1ml syringe
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
12-months
Extraction
Cryo-ethanol extraction
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

THC Dominant

<1mg/ml CBD – 25mg/ml THC – 30ml
Parameters
Specification
Formulation
> 95% THC, minors according to DAC monograph
Product Type
DAC Dronabinol in oily base, MCT-oil formulated according to NRF 22.8
Appearance
Clear viscous liquid, solid a room temperature
Packaging
Insert Argon purged. Amber glass bottle 50ml, 500ml and 2.5L. Glass Type III Polypropylene (PE) Cap
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
12-months
Extraction
Cryo-ethanol extraction
Chromatography purification
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

THC Solution 25mg/ml

Parameters
Specification
Product Type
Purified THC in oily base, MCT-Oil
Formulation
25mg/ml THC
Appearance
Clear, almost colourless to slightly yellowish viscous solution
Packaging
50ml, 200ml or 500ml amber glass jar Type III, white CR screw cap, magisterial preparation format with TE cap (PP), 2 x THC strip, reaction tube, sterile pipett
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
Ongoing - expected 12 months
Extraction
Solvent extraction and formulation
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

Indica Strains*

Critical Kush

THC: 25%

Black Cherry Punch

THC: 25%

Blueberry Kush

THC: 24%

Gooseberry Pie

THC: 22%

Chemdog x UK Cheese

THC: 21%

Bubba OG

THC: 20%

Blueberry Muffin

THC: 20%

* More available on request

Hybrid Strains*

Sour OG Cheese

THC: 27%

Royal Gorilla

THC: 25%

White Lemon

THC: 24%

Blunicorn

THC: 20%

Creamy Kees

THC: 20%

UK Cheese

THC: 20%

Orange Velvet Underground

THC: 20%

* More available on request