The Proteintech Advantage

The Proteintech Advantage. A picture containing text items Description automatically generated.

HumanKine ® Recombinant Proteins. Cytokines Chemokines Growth Factors Interleukins Human Serum Albumin (HSA).

The HumanKine ® Advantage. All HumanKine ® products are expressed in HEK293 systems Native human conformation Native human post translational modifications Relevant biological activity.

The HumanKine ® Advantage. Authentic human proteins with optimized biological activity For humans, by human cells Products developed for advanced therapy manufacturers and regenerative medicine GMP compliant for ease of tech transfer.

The HumanKine ® Advantage. Cow. Animal-Component-Free.

HumanKine ® Case Studies.

FGF Basic-TS (Thermostable). FGF basic-TS is stable in culture for up to 3 days at 37 °C Superior stability to competitor products Maintains pluripotency on 3 day feeding schedule High purity and consistent lot-to-lot activity.

FGF Basic-TS: Millipore Study. EMD Millipore compared biological function of HumanKine ® FGF basic-TS and competitor FGF basic over 1 week HumanKine ® FGF basic-TS has enhanced stability vs standard FGF basic HumanKine ® FGF basic-TS has enhanced biological functionality human iPS (pluripotency) and neural progenitor cells (multipotency) in limited feeding schedule.

FGF Basic-TS: Millipore Study. A picture containing text, different, colorful Description automatically generated.

FGF Basic-TS: Hebe Cell Study. Comparison of HumanKine ® FGF basic-TS, competitor’s FGF basic-TS and standard FGF basic Greater expansion of ESCs with HumanKine ® FGF basic-TS in comparison to competitor products.

E. coli cells Human cells s 2000 — 1000 10 ILIß (ng/mL) E_ coli cells Human cells 3000 2000 1000 10 IL6 (ng/mL) Insect cells Human cells S 2000 — 1000 10 IL23 (ng/mL) Insect cells Human cells 3000 2000 1000 0.2 TGFß1 (ng/mL).

Human Vs bacterial-expressed proteins Higher efficiency production of IL-6 in rheumatoid synoviocytes using HumanKine ® TNF alpha vs E.coli expressed TNF alpha.

Human Vs bacterial-expressed proteins Size exclusion comparison of authentic human TNF alpha 51kDa trimer vs E.coli expressed monomer..

HumanKine ® BMP-2 promotes bone formation in vivo.

Lot-to-lot Consistency Example: Activin A. Chart Description automatically generated.

Lot-to-lot Consistency Example: BMP-4. 170 130 53 42 93 70 30 23 14 10 Lot 3 kDa DTT: + + - -.

Robust Long-Term Stability. Diagram Description automatically generated.

Human Wnt-3A Outperforms. Chart Description automatically generated.

Direct, Robust, Scalable Supply. Purpose built, large scale, GMP facility to fulfil increasing demand Optimized yield expressing in stable HEK293 systems Safety, efficacy and lot to lot consistency for therapeutic manufacturing Robust scalability from preclinical to clinical and commercial quantities Seamless transition from research to GMP grade, using same sequence and process.

GMP Quality. HumanKine ® GMP recombinant proteins offer safety, purity, stability, and potency to use in ex vivo manufacturing processes, as defined in USP (United States Pharmacopeia) Chapter <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products, USP Chapter <92> Growth Factors and Cytokines Used in Cell Therapy Manufacturing, WHO TRS, No. 822, 1992 Annex 1 Good Manufacturing Practices for Biological Products. In line with: European Ph.Eur 5.2.12 general chapter on raw materials of biological origin for the production of cell based and gene therapy medicinal products. Materials used during the manufacture of the active substance (e.g. culture media, growth factors) and that are not intended to form part of the active substance shall be considered as raw materials..

GMP Quality. Documented processes Raw material and vendor qualification Monitoring and qualification of cleanrooms, instruments and equipment Validated processes, SOPs and assays Well defined standards an in-process quality checks (IPQC) Systematic and organised training program for qualified personnel Documentation and traceability Deviations and corrective action preventative actions (CAPA) Final product QC release.

Risk Based Approach USP <1043>: Ancillary Materials for Cell, Gene and Tissue-Engineered Products Tier Criteria Examples Highlights Risk Tier 1 Intended as licenced drugs, biologics or medical devices. Suitability as a manufacturing component required because formulation, stability profile and other quality aspects may change once introduced to the manufacturing process. Implantable materials, injectable recombinant antibodies, IV bags, tubing, syringes Highly qualified, licenced / approved materials LOW Tier 2 Intended as ancillary materials. Well characterised and produced under QMS according to GMP guidelines, well suited for biological manufacturing but the material is not a licenced medical product. GMP cytokines, growth factors and recombinant proteins , culture media, immune-magnetic beads Produced to GMP, ACF, xeno free, endotoxin free. Recombinant GMP HSA , low risk alternative to FCS LOW Tier 3 Not intended for use in biological manufacturing. Can be approved by regulators as part of an in vitro diagnostic device. Requires much more qualification than tier 1 or 2. Monoclonal antibodies, research grade cytokines, process buffers Produced for research, not intended for use in cell and gene therapies MODERATE Tier 4 Industrial or research grade materials, may contain harmful impurities. May contain animal or human derived components with potential contaminants. Extensive qualification before use in biological product manufacturing. Fetal bovine serum, feeder cells Not intended for use as an ancillary material in cell or gene therapy, not manufactured to GMP. HIGH.

Seamless transition from RUO to GMP. HumanKine ® Research Grade Research and development HumanKine ® GMP Grade Technology transfer HumanKine ® GMP Grade Late phase clinical trials Preclinical development USP<1043> Risk 3 Early phase clinical trial USP <1043> Risk 2 Commercial manufacturing USP <1043> Risk 2.

Quality features RUO GMP QMS: Manufactured, tested, released & distributed under I SO 13485 Endotoxin testing Change control Equipment qualification Analytical methods Qualified Qualified & Validated Real time and accelerated stability studies Process validation 3 batches GMP Compliance Regulatory compliance: USP <1043>, Ph. Eur. 5.2.12, WHO TRS, No. 822, 1992 Annex 1 N/A.

CoraLite® Product Focus.

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WWW.PTGLAB.COM. IF analysis of fixed mouse testis tissue. Green: CoraLite®488 BOULE antibody (CL488-13720) Red: CoraLite®594 DAZL antibody (CL594-12633) Magenta: CoraLite®647 TNP1 antibody (CL647-17178).

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VVWW.PTGLAB'.COM. IF analysis of human breast cancer tissue. Red: CoraLite®594 HER2/ErbB2 monoclonal antibody (CL594-60391) Green: CoraLite®488 KI67antibody (CL488-27309).

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