OptiLeukin™ 2 – Recombinant human interleukin-2

Product Description

OptiLeukin 2™ is a recombinant human interleukin-2 (rhIL-2) produced on InVitria's ExpressTec expression platform — a non-bacterial, non-mammalian, animal-origin-free expression system designed for cell therapy manufacturing applications where consistent, well-characterized IL-2 bioactivity is critical. OptiLeukin 2 is available in three formats to support research, process development, and cGMP cell therapy manufacturing workflows: a 100 µg lyophilized powder, a liquid format, and a liquid closed-system format engineered for integration into closed-loop CAR-T, TIL, NK, Treg, and γδ T cell manufacturing processes. The closed-system cGMP format is released at ≥98% purity, ≤0.01 EU/µg endotoxin, and ED50 ≤1 pg/mL activity calibrated against the 1st International Standard for IL-2 — supporting the T-cell expansion, activation, and transduction requirements of autologous and allogeneic cell therapy programs from research through clinical manufacturing.

OptiLeukin 2 is distinct from the E. coli-derived recombinant IL-2 products that dominate the category. Because OptiLeukin 2 is produced in a non-bacterial expression system, the product has an endotoxin specification of ≤0.01 EU/µg, lower than the typical of E. coli-derived recombinant IL-2. The ExpressTec platform also expresses IL-2 in soluble, native form, eliminating the inclusion body solubilization and refolding steps that E. coli-expressed IL-2 typically requires — a manufacturing difference that reduces the potential for refolding-associated structural heterogeneity and residual process impurities. For cell therapy manufacturing programs where raw material qualification, CMC documentation, and process control are critical regulatory considerations, the non-bacterial expression profile simplifies adventitious agent qualification and supports ICH regulatory pathways.

OptiLeukin 2 has been characterized in InVitria's application note Sustained T Cell Proliferation and Early Memory Retention with OptiLeukin 2 Recombinant IL-2, which documents sustained T-cell proliferation and retention of favorable early memory-associated phenotypes (Tscm, Tcm) under defined expansion conditions — process attributes that are directly associated with improved CAR-T cell persistence and clinical durability. The closed-system format supports integration into closed-loop cell therapy manufacturing workflows where sterile, chemically defined raw materials are required. OptiLeukin 2 is manufactured under an ISO 9001:2015-certified, cGMP-compliant quality management system with full release testing on every lot including purity, endotoxin, activity, identity, sterility, and mycoplasma. Full regulatory documentation — including Certificate of Analysis, Safety Data Sheet, Guidelines for Use, Animal-Free Statement, and cGMP Statement — is available to support IND and BLA submissions for cell therapy and immunotherapy programs.

Advantages

Validated for T-Cell Memory Phenotype Preservation During Expansion

• InVitria's application note Sustained T Cell Proliferation and Early Memory Retention with OptiLeukin 2 Recombinant IL-2 documents sustained T-cell proliferation and retention of favorable early memory-associated phenotypes (Tscm, Tcm) under defined expansion conditions — process attributes directly associated with improved CAR-T cell persistence and clinical durability.
• OptiLeukin 2 supports the T-cell expansion, activation, and transduction requirements of autologous and allogeneic cell therapy programs where maintaining a less differentiated T-cell phenotype is a critical process attribute.
• Performance is comparable to leading GMP IL-2 products for T-cell proliferation and phenotype, supporting like-kind evaluation for programs seeking a cleaner raw material profile with simplified comparability justification.

Free of Bacterial Expression Host and Bacterial Endotoxin Source

• OptiLeukin 2 is produced on InVitria's ExpressTec expression platform — a non-bacterial, non-mammalian, animal-origin-free system — eliminating the bacterial endotoxin source intrinsic to E. coli-derived recombinant IL-2.
• Expression in soluble, native form eliminates the inclusion body solubilization and refolding steps required for E. coli-expressed IL-2 — simplifying the structural homogeneity and process impurity profile relevant to CMC documentation.

Closed-System Format for cGMP Cell Therapy Manufacturing

• OptiLeukin 2 is available in a closed-system format (catalog 777OLK107) designed for integration into closed-loop CAR-T, TIL, NK, Treg, and γδ T-cell manufacturing processes where sterile, chemically defined raw materials are required.
• Three SKU formats support research through cGMP manufacturing:  lyophilized powder,  liquid, and liquid closed-system format — providing format continuity as customer programs scale from research through clinical manufacturing.
• Activity is calibrated to the 1st International Standard for IL-2 with ED50 ≤1 pg/mL, supporting consistent cytokine performance across research, development, and manufacturing.

Regulatory-Ready Documentation and Manufacturing

• OptiLeukin 2 is manufactured under an ISO 9001:2015-certified, cGMP-compliant quality management system with full release testing on every lot including purity (≥98%), endotoxin (≤0.01 EU/µg), activity, identity, sterility, and mycoplasma (closed-system cGMP format).
• Complete regulatory package available: Certificate of Analysis, Safety Data Sheet, Guidelines for Use, Certificate of Origin and Animal-Free / TSE-BSE Statement, ISO 9001 certificate, and cGMP Statement.
• Animal-origin-free profile simplifies ICH adventitious agent qualification and supports IND/BLA-stage CMC documentation for cell therapy, gene therapy, and immunotherapy programs.

Applications

CAR-T and T-Cell Manufacturing. OptiLeukin 2™ supports T-cell activation, expansion, and transduction workflows in CAR-T, TCR-engineered, and other T-cell–based cell therapy manufacturing processes. InVitria's application note Sustained T Cell Proliferation and Early Memory Retention with OptiLeukin 2 Recombinant IL-2 documents sustained T-cell proliferation and retention of favorable early memory-associated phenotypes (Tscm, Tcm) under defined expansion conditions — process attributes directly associated with improved CAR-T cell persistence and clinical durability. The closed-system format is designed for integration into closed-loop CAR-T manufacturing workflows where sterile, chemically defined raw materials are required, while the bacteria-free expression profile and ≤0.01 EU/µg endotoxin specification support raw material qualification for IND/BLA-stage cell therapy programs. OptiLeukin 2 is suitable for both autologous and allogeneic T-cell therapy manufacturing at research, process development, and clinical scales.

NK and γδ T-Cell Expansion for Allogeneic Cell Therapy. OptiLeukin 2 supports NK cell and γδ T-cell expansion workflows in allogeneic "off-the-shelf" cell therapy manufacturing programs. IL-2 signaling drives NK cell proliferation, cytotoxicity, and effector function, and is similarly critical for γδ T-cell expansion protocols that require sustained cytokine support to achieve clinically relevant cell doses. The defined, animal-origin-free composition supports chemically defined manufacturing workflows where elimination of serum and bacterial-derived raw materials is a process development priority, and the International Standard activity specification supports consistent cytokine performance across expansion cycles. The closed-system cGMP format enables seamless integration into allogeneic manufacturing platforms where scale, consistency, and regulatory-ready raw materials drive supplier selection.

Regulatory T-Cell (Treg) and TIL Manufacturing. OptiLeukin 2 supports regulatory T-cell (Treg) and tumor-infiltrating lymphocyte (TIL) expansion workflows in emerging cell therapy modalities for autoimmune disease and solid tumor indications. Treg manufacturing processes depend on IL-2 signaling for cell expansion while maintaining the FOXP3+ regulatory phenotype — a process-critical quality attribute where consistent, well-characterized cytokine performance affects product specification. TIL manufacturing, which supports solid tumor cell therapy approaches, similarly depends on high-dose IL-2 during the rapid expansion protocol (REP) phase. OptiLeukin 2's recombinant, bacteria-free profile and tight endotoxin specification support the raw material qualification requirements of both Treg and TIL clinical manufacturing programs.

iPSC-Derived Immune Cell Differentiation. OptiLeukin 2 supports serum-free and chemically defined culture of iPSC-derived immune cell lineages, including iPSC-derived NK cells (iNK), iPSC-derived T cells (iT), and other immune-modulatory cell populations being developed for next-generation allogeneic cell therapies. IL-2 signaling drives proliferation and functional maturation of differentiated immune cell lineages during iPSC-based manufacturing platforms where fully defined, animal-origin-free raw materials are critical to the translational requirements of regenerative medicine programs. The ExpressTec expression platform and defined release specifications align with the CMC and regulatory expectations for iPSC-derived cell therapy products progressing toward IND and BLA submissions.

Serum-Free and Chemically Defined Immune Cell Media Formulation. Beyond dedicated cell therapy manufacturing workflows, OptiLeukin 2 serves as a reliable IL-2 component in the formulation of fully chemically defined and serum-free media systems across immune cell culture applications. The product is compatible with common basal media used in T-cell and NK-cell culture including RPMI 1640, X-VIVO 15, AIM V, and proprietary serum-free formulations, and is designed for use in combination with defined cytokine and supplement cocktails during process development. Working concentration is determined empirically based on cell type, activation method, and culture density, typically bracketed during process development to balance proliferation rate and phenotype outcomes. The three format provide format continuity as customer programs scale from research through cGMP clinical manufacturing, with the closed-system cGMP format (catalog 777OLK107) supporting integration into closed-loop cell therapy manufacturing processes.

OptiLeukin 2 Frequently Asked Questions (FAQs)

Product Overview

What Is OptiLeukin 2 and How Does It Support Immune Cell Expansion?

OptiLeukin 2 is a recombinant human interleukin-2 (rhIL-2) produced on InVitria's ExpressTec expression platform — a non-bacterial, non-mammalian, animal-origin-free expression system. OptiLeukin 2 is available in three formats: a 100 µg lyophilized powder (catalog 555OLK0070), liquid format (777OLK108), and a closed-system format (catalog 777OLK107). The closed-system cGMP format delivers ≥98% purity, ≤0.01 EU/µg endotoxin, and ED50 ≤1 pg/mL activity calibrated against the International Standard, supporting T-cell, Treg, TIL, NK, and γδ T-cell expansion workflows across research, process development, and clinical manufacturing.

What Is OptiLeukin 2 Made From?

OptiLeukin 2 is produced recombinantly on InVitria's ExpressTec expression platform — a non-bacterial, non-mammalian, non-human expression system with no animal-derived, human-derived, or blood-derived materials. The product is manufactured without any animal-derived components in raw materials, processing aids, or manufacturing equipment — supporting ICH compliance and simplifying adventitious agent qualification for cell therapy, gene therapy, and immunotherapy regulatory submissions.

Composition and Specifications

What Are the Release Specifications for OptiLeukin 2?

The closed-system cGMP format (catalog 777OLK107) is released at ≥98% purity, ≤0.01 EU/µg endotoxin, ED50 ≤1 pg/mL activity (International Standard), sterile, mycoplasma-negative, and with identity confirmed against the reference standard. Every lot is released with full Certificate of Analysis documentation covering purity, endotoxin, activity, identity, sterility, mycoplasma, pH, protein concentration, and host cell protein content.

How Is OptiLeukin 2 Potency Measured and Verified Across Lots?

OptiLeukin 2 potency is calibrated against the  International Standard for IL-2 with an ED50 specification of ≤1 pg/mL, released on every lot. Programs typically confirm performance in their specific expansion protocol and verify comparability to prior lots during process development to ensure consistent cytokine performance across research, development, and manufacturing phases.

Regulatory and Quality

Is OptiLeukin 2 cGMP-Manufactured and Animal-Origin-Free?

Yes. OptiLeukin 2 is manufactured under an ISO 9001:2015-certified, cGMP-compliant quality management system. The product is 100% animal-origin-free — raw materials, the recombinant protein expression platform, manufacturing equipment, and product-contact packaging are all free of animal-derived components.

What Quality Documentation Is Available for OptiLeukin 2?

OptiLeukin 2 is supported by a Certificate of Analysis, Safety Data Sheet, Guidelines for Use, application notes describing immune cell expansion performance, Certificate of Origin and Animal-Free / TSE-BSE Statement, ISO 9001 certificate, and cGMP Statement. Additional Quality and Regulatory documentation is available on request, including materials for IND-supporting packages and supplier qualification.

Does OptiLeukin 2 Support ICH Q5A Compliance?

Yes. OptiLeukin 2 is produced on a non-bacterial, non-mammalian, non-human expression system with no animal-derived, human-derived, or plasma-derived raw materials, aligning with ICH Q5A guidance on viral safety evaluation of biotechnology products derived from cell lines. The absence of bacterial, animal, and plasma source materials eliminates the adventitious agent qualification burden associated with E. coli-derived, HEK293-derived, and plasma-containing IL-2 sources — simplifying CMC documentation for biopharmaceutical, cell therapy, and gene therapy programs.

Does InVitria Provide a Drug Master File (DMF) or Equivalent Regulatory Documentation for OptiLeukin 2?

InVitria provides a product-specific Technical Summary for OptiLeukin 2 containing CMC-style documentation — including manufacturing process, raw material controls, characterization data, release specifications, and lot analysis — designed to support customer regulatory submissions globally, including IND, BLA, and comparable filings under FDA, EMA, and other regulatory authorities. Unlike a Drug Master File, the Technical Summary is provided directly to the customer for incorporation into their own regulatory documentation, giving customers full visibility into the CMC information and supporting global filings without being tied to a single regulatory pathway. The OptiLeukin 2 Technical Summary is supported by per-lot Certificates of Analysis, Animal-Origin-Free / TSE-BSE statements, ISO 9001 certification, cGMP statements, and change notification under defined policies. Contact us to request the Technical Summary.

Research Validation

Does OptiLeukin 2 Support T-Cell Memory Phenotype During Expansion?

Yes. InVitria's application note Sustained T Cell Proliferation and Early Memory Retention with OptiLeukin 2 Recombinant IL-2 documents sustained T-cell proliferation and retention of favorable early memory-associated phenotypes (Tscm, Tcm) under defined expansion conditions. These results support OptiLeukin 2's use in cell therapy manufacturing programs where maintaining a less differentiated T-cell phenotype is a critical process attribute directly associated with improved CAR-T cell persistence and clinical durability.

How Does OptiLeukin 2 Compare to Leading GMP IL-2 Products?

InVitria's application note documents OptiLeukin 2 performance comparable to leading GMP IL-2 products for T-cell proliferation and phenotype. The comparability data supports evaluation of OptiLeukin 2 for programs seeking a cleaner raw material profile — specifically, a bacteria-free expression system, tighter endotoxin specification (≤0.01 EU/µg vs. ≤1 EU/µg typical), and the closed-system format for cGMP cell therapy manufacturing workflows.

Selection and Comparison

How Is OptiLeukin 2 Different From E. coli-Derived Recombinant IL-2?

The primary difference is the expression system. OptiLeukin 2 is produced on InVitria's ExpressTec platform — a non-bacterial expression system that eliminates the bacterial endotoxin source intrinsic to E. coli-derived recombinant IL-2, enabling the ≤0.01 EU/µg endotoxin specification that is approximately 100-fold tighter than typical E. coli-derived IL-2. OptiLeukin 2 is also expressed in soluble, native form, eliminating the inclusion body solubilization and refolding steps required for E. coli-expressed IL-2 — a manufacturing difference that simplifies the structural homogeneity and process impurity profile relevant to CMC documentation.

Which OptiLeukin 2 Format Should I Use for My Application?

The lyophilized powder (catalog 555OLK0070) supports research-scale T-cell, NK-cell, and Treg expansion workflows where reconstitution flexibility is preferred. The liquid format (catalog 777OLK108) supports process development and scale-up workflows where a pre-reconstituted format simplifies workflow integration. The closed-system format (catalog 777OLK107) is the cGMP-grade offering designed for closed-loop CAR-T, TIL, NK, Treg, and γδ T-cell manufacturing workflows where sterile, mycoplasma-negative, regulatory-ready raw materials are required. Contact InVitria to discuss the best format option for your specific application.

Application and Use

Is OptiLeukin 2 Suitable for CAR-T, TIL, or NK Cell Manufacturing?

Yes. OptiLeukin 2 is designed for expansion workflows across CAR-T, TIL, Treg, NK, and γδ T-cell manufacturing programs. The closed-system cGMP format integrates into closed-loop cell therapy manufacturing processes where sterile, chemically defined raw materials are required, while the bacteria-free expression profile and ≤0.01 EU/µg endotoxin specification support raw material qualification for IND/BLA-stage cell therapy programs.

What Immune Cell Types and Workflows Is OptiLeukin 2 Designed For?

OptiLeukin 2 is designed for expansion workflows involving T cells, Tregs, TILs, NK cells, and γδ T cells in cell therapy development and manufacturing — including autologous CAR-T manufacturing, allogeneic "off-the-shelf" NK and γδ T-cell programs, regulatory T-cell therapies for autoimmune disease, TIL therapies for solid tumor indications, and iPSC-derived immune cell differentiation platforms. The defined, animal-origin-free composition supports chemically defined media systems across all of these applications.

How Do I Reconstitute OptiLeukin 2 for Use in Cell Culture?

The Guidelines for Use describe reconstitution of the lyophilized format in sterile PBS or culture-grade water with gentle mixing; avoid vortexing to prevent foaming. Sterile filtration through a 0.2 µm filter prior to use is recommended. The liquid and closed-system formats are supplied pre-reconstituted and do not require additional reconstitution steps.

What Concentration of OptiLeukin 2 Should I Use in My Expansion Protocol?

The Guidelines for Use provide a typical stock concentration range and recommend optimizing the working dose based on cell type, activation method, and culture density. Working concentrations are typically bracketed during process development to balance proliferation rate and phenotype outcomes — particularly in CAR-T and Treg workflows where maintaining less-differentiated phenotypes is a critical process attribute.

Which Basal Media Is OptiLeukin 2 Compatible With?

OptiLeukin 2 is compatible with common basal media used in T-cell, NK-cell, Treg, and TIL expansion workflows, including RPMI 1640, X-VIVO 15, AIM V, and proprietary serum-free and chemically defined formulations. The product is typically added directly to basal medium at the empirically determined working concentration as part of a complete defined or serum-free expansion formulation.

Packaging and Ordering

What Packaging Options Are Available for OptiLeukin 2?

OptiLeukin 2 is available in three formats: a lyophilized powder, a liquid format, and a closed-system format designed for cGMP cell therapy manufacturing workflows. Contact InVitria for bulk and custom packaging options to support cell therapy process development and clinical manufacturing.

How Can I Order Optileukin 2?

OptiLeukin 2 is available worldwide through multiple purchasing pathways. Most customers work directly with InVitria for full access to the OptiLeukin 2 product portfolio, bulk and commercial-scale supply, favorable volume-tier pricing, faster supply chain turnaround, GMP supply commitments, and regulatory documentation support. OptiLeukin 2 is also available through Fisher Scientific, VWR, and the Labviva procurement platform (which integrates with Ariba, Coupa, Oracle, and Jaggaer) for customers whose institutional procurement systems require integrated supplier ordering. European customers can order with direct fulfillment from InVitria's Rotterdam, Netherlands facility. All customers receive the same product, Certificate of Analysis, and technical support regardless of channel. Contact InVitria or request bulk pricing to place an order.

Storage and Handling

How Should OptiLeukin 2 Be Stored?

Store OptiLeukin 2 in powder format at –20 °C, OptiLeukin 2 in liquid format at 2–8°C per the Guidelines for Use and product Certificate of Analysis.

Related Resources