Questions about SysGene Biologics

SysGene Biologics is a biologics company founded in 2026 and registered as SYSGENE BIOLOGICS PRIVATE LIMITED in Hyderabad, India. It is guided by a simple belief: essential biologics should be more accessible and affordable.

SysGene works three ways at once: as the owner of two patented expression platforms, as a bioprocess development service provider, and as the manufacturer of bioprocess and recombinant protein products in five categories. More about SysGene

The registered office is at #8-2-686/8/D/5, Road No. 12, Khairatabad, Hyderabad, Telangana 500034, India. SysGene operates its in-house mammalian bioreactor and microbial fermentation capacity in Hyderabad.

• Andrew Mitchell, Chief Executive Officer
• JC Pavan Reddy, Director
• Nisheeth Rao Juvvadi, Director

Mission: to assist patient populations through our clients, in improving access to essential products, through cost reductions utilising our platforms enabling faster, more efficient and scalable approaches to development and manufacturing of drug substances.

Vision: through scientific rigor, collaboration and transparency to become a trusted development, scale up and manufacturing partner or technology-transfer partner for key GMP & non-GMP molecules for biologic entities and peptides. Principles that guide how we work

Yes. The SysGene Biologics Overview 2026 brochure (PDF, 1.2 MB) can be downloaded from the top bar or the footer of any page, or download the brochure here.

SysGene Biologics is on LinkedIn and YouTube.

SysGene owns two patented expression platforms:

• Patented Bacterial Secretion Platform: designed to produce suitable recombinant proteins and peptides directly into the culture medium.
• Patented Mammalian Expression Platform: a CHO-based platform for complex and glycosylated biologics that require mammalian folding, assembly and post-translational processing.

The molecule determines the route, not a one-size-fits-all process. Every program begins with the molecule’s structure, function and quality requirements.

For compatible molecules, bacterial secretion can simplify recovery by reducing reliance on cell lysis, inclusion-body isolation, solubilization and refolding. Mammalian expression is the route for molecules whose folding, assembly or post-translational processing a microbial host cannot provide.

Yes. The patented bacterial secretion and mammalian expression platforms are available through SysGene for selected development, licensing and technology-transfer programs. Platform and product availability, grade and performance are subject to program-specific evaluation and qualification.

Both platforms have been established at laboratory scale, and every product in the SysGene portfolio has been designed, developed and manufactured using them. Platform performance, scale-up requirements and product quality are evaluated separately for each molecule.

The Patented Bacterial Secretion Platform is designed to produce suitable recombinant proteins and peptides directly into the culture medium. Because the product is secreted, downstream work can begin from the culture medium rather than from harvested, disrupted cells.

• Where lysis and refolding can be avoided, there may be fewer unit operations to develop, document and transfer.
• Starting outside the cell can leave less intracellular material in the purification feed, depending on the molecule and process.
• Product recovery begins from clarified culture supernatant, which may reduce downstream complexity and impurity burden.

More about the bacterial secretion platform

The Patented Mammalian Expression Platform is CHO-based, for complex and glycosylated biologics that require mammalian folding, assembly and post-translational processing. CHO cells are among the most widely used hosts for recombinant therapeutic proteins. It offers a connected development route:

• Cell-line, media and feed development.
• Fed-batch or perfusion process development.
• Connected analytics, scale-up and technology transfer.

Mammalian bioreactor capacity is available at 5 L in Hyderabad, with larger scales assessed program by program. More about the mammalian expression platform

SysGene assesses molecular structure, biological function and post-translational processing requirements to evaluate production feasibility and define the target quality profile. Selection of microbial (E. coli/Pichia) or mammalian (CHO/HEK) expression systems considers protein folding, secretion, purification requirements and the intended manufacturing scale.

The process mode is chosen per molecule rather than fixed by the platform. On the bacterial secretion platform, batch or perfusion is selected against the molecule and program goals; on the mammalian expression platform, fed-batch or perfusion.

Technical information is presented according to the strength and source of the supporting evidence, so confirmed specifications can be told apart from other data:

• Validated specification: a confirmed product specification supported by an approved test method and controlled documentation.
• Representative result: a result observed under defined study or program conditions.
• Development target: a performance objective under evaluation that has not yet been established as a product specification.
• External benchmark: published third-party data used to provide relevant technical or market context.

Platform results are molecule- and process-specific. Reported development outcomes do not guarantee equivalent performance for other products, scales or manufacturing configurations.

• Upstream development: expression strategy, host or cell-line work, media and process-mode development.
• Downstream purification: primary recovery, capture chromatography and polishing.
• Analytics and characterization: identity, purity, binding, activity and impurity-control methods.
• Scale-up and transfer: non-GMP and GMP manufacturing scale, documentation and site-transfer support.

SysGene operates in-house mammalian bioreactor capacity at 5 L scale and microbial fermenters from development scale to 30 L, 100 L, and 1,000 L in Hyderabad, with 5,000 L capacity planned. Programs may be scoped for GMP or non-GMP manufacture, subject to facility, product and regulatory fit. Additional capacity and specialized capabilities may be delivered through qualified partners.

SysGene characterizes peptides, recombinant proteins and monoclonal antibodies across primary, secondary and higher-order structure and biological function, using methods such as LC-MS/MS, peptide mapping, CD, FTIR, DSC, SEC-MALS, DLS, SPR and cell-based assays.

SysGene’s upstream development capabilities span microbial fermentation and mammalian cell culture. Media composition, feeding strategies and cultivation conditions are tailored to each molecule and expression system, with a focus on improving productivity, maintaining product quality and establishing consistent process performance. Downstream recovery and purification requirements are considered from the outset. Upstream process development

SysGene supports downstream process development for monoclonal antibodies, Fc-fusion proteins and other recombinant proteins produced through microbial and mammalian expression systems. Capabilities span primary recovery and clarification, affinity capture, chromatographic purification and polishing, alongside membrane-based concentration and buffer exchange. Downstream purification

Yes. Targeted impurity testing supports the assessment of purification effectiveness, including evaluation of host-cell proteins, residual DNA and endotoxin where relevant to the expression system and process. Analytics and characterization

SysGene connects non-GMP microbial and mammalian development with GMP microbial manufacture at 30, 100 and 1,000 L. Programs may be scoped for GMP or non-GMP manufacture, subject to facility, product and regulatory fit. Additional capacity and specialized capabilities may be delivered through qualified partners.

Technology transfer is tailored to the receiving facility’s equipment, capabilities and process requirements. SysGene supports the preparation of process descriptions, operating procedures, batch documentation and analytical methods, and helps the receiving team establish the workflow through technical collaboration, training and troubleshooting support. Agreed transfer activities and acceptance criteria provide a clear basis for evaluating process performance and reproducibility at the destination facility. Scale-up and transfer

The US FDA defines a protein as any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size; a polymer of 40 amino acids or fewer is a peptide.

• Peptides (MW ~0.5–5 kDa): short linear or simple cyclic chains that lack tertiary folding. Analytical focus: molecular weight and LC-MS purity.
• Proteins (MW ~10–100+ kDa): complex folded 3D structures, susceptible to denaturation and aggregation. Analytical focus: secondary and tertiary folding, and activity.
• Monoclonal antibodies (MW ~150 kDa): Y-shaped four-chain glycoproteins with complex post-translational modifications. Analytical focus: glycosylation, charge variants and binding.

Five product categories:

• Affinity resins & ligands: Protein A Resins (mAbOn-A® and PLAG-On), Protein L Resins (FabOn-L®) and Affinity Ligands (Protein A, Protein G, Protein L and combined A/L/G ligands)
• Enzymes & research reagents: DRNase®, mRNA Manufacturing Enzymes (T7 RNA Polymerase, DNase I, IPPase and RNase Inhibitor), Trypsin, Carboxypeptidase B, Lys-C and Glu-C and Recombinant Streptavidin
• Cytokines & growth factors: Recombinant EGF, Growth Factors (FGF2, VEGF, TGF-α and GM-CSF) and Interleukins (IL-2, IL-4, IL-7, IL-15 and IL-21)
• Hormones & therapeutic proteins: LR3-IGF-1, human growth hormone and recombinant human serum albumin
• Peptides & specialty products: Cell-Permeable Peptides

SysGene products are manufactured to the requirements of their stated grade, research grade, multi-compendial or GMP. The applicable grade and its supporting documentation are confirmed for each product.

Development, characterization and analytical activities are aligned with the International Council for Harmonisation (ICH) guidelines for biotechnological products, including ICH Q6B, ICH Q5E and ICH Q2(R2). SysGene’s GMP standards are based on ICH Q10.

Product-specific specifications and availability are provided on request. Use the contact form and choose “Request a quote”, “Evaluation sample or availability” or “Technical documentation”, or email info@sysgene.com.

mAbOn-A® is a Protein A affinity resin designed for antibody capture and compatibility with alkaline cleaning. The Protein A range also includes PLAG-On, an affinity resin concept intended for recovery of multiple immunoglobulin classes from plasma. Process suitability, operating conditions and cleaning regimes are application-specific and confirmed through evaluation. Protein A Resins

FabOn-L® is a Protein L affinity resin intended for capture of compatible kappa-containing antibody fragments and Fc-free formats. Molecule compatibility requires evaluation on a case-by-case basis. Protein L Resins

Yes. Recombinant Protein A, Protein G and Protein L ligands are supplied for coupling to your own matrix. Ligand choice, coupling and performance are confirmed for each program.

• Alkali-stable Protein A ligand, for resins cleaned in place with sodium hydroxide.
• High-pH-elution Protein A ligand, for acid-sensitive molecules.
• Protein L ligand, for whole antibodies and fragments such as Fab and scFv.
• Protein G ligand, binding the Fc region of IgG across a broad range of species and subclasses.
• Combined Protein A/L/G ligand, for broad capture of antibodies and antibody fragments.

Affinity Ligands

DRNase® is a recombinant endonuclease intended for DNA and RNA reduction in bioprocessing. The addition point, contact time, removal strategy and downstream compatibility are confirmed for each process. DNase I is a distinct product, part of the mRNA Manufacturing Enzymes range, intended for removal of DNA templates after transcription. DRNase®

• T7 RNA Polymerase: RNA synthesis from a DNA template containing a T7 promoter.
• DNase I: removal of DNA templates after transcription.
• IPPase: hydrolysis of inorganic pyrophosphate generated during transcription.
• RNase Inhibitor: protection of RNA against susceptible RNases during RNA-handling workflows.

Product-specific specifications and availability are provided on request. mRNA Manufacturing Enzymes

• Trypsin: protease for protein cleavage, preferentially after lysine and arginine residues.
• Lys-C: endoproteinase that cleaves on the carboxyl side of lysine residues.
• Glu-C: endoproteinase that cleaves on the carboxyl side of glutamic acid residues, and also after aspartic acid in phosphate buffer.
• Carboxypeptidase B: exopeptidase for removal of C-terminal lysine or arginine residues.

Lys-C and Glu-C give peptide maps that complement a tryptic digest. Trypsin · Lys-C and Glu-C · Carboxypeptidase B

Recombinant IL-2, IL-4, IL-7, IL-15 and IL-21, recombinant EGF, and the growth factors FGF2, VEGF, TGF-α and GM-CSF, for research and cell-culture applications. Specifications, potency and formulation are confirmed for each product and grade.

Interleukins · Growth Factors · Recombinant EGF

Long R3 IGF-I, an IGF-I analog with reduced binding to IGF-binding proteins, used as a cell-culture supplement in bioprocessing. It is offered with recombinant human growth hormone and animal-free recombinant human serum albumin for research, process development and licensing programs. These products are not finished medicines; for therapeutic development, grade (including GMP), documentation and regulatory support are agreed for each program. Hormones & Therapeutic Proteins

Yes, peptides that cross cell membranes, for intracellular delivery research. Sequences, modifications and specifications are provided on request: tell SysGene the sequence or application, any cargo or conjugate, and the purity you need. Cell-Permeable Peptides

Unless the product page, label or certificate of analysis states otherwise, products are supplied for research use and for use in further manufacturing. They are not medicines or diagnostic products and must not be administered to humans or animals. For therapeutic development programs, grade (including GMP), documentation and regulatory support are agreed for each program.

Multi-compendial products are specified against the relevant monographs of more than one pharmacopoeia, such as the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.) and Japanese Pharmacopoeia (JP).

Each lot is released against its specification, and lot-specific certificates of analysis are available on request, as are data sheets and safety data sheets.

Choose a product and pack size on any product page, or tell us the quantity you need, and request a quotation. SysGene replies within three business days with pricing, availability and delivery for your destination.

An order is placed by accepting the quotation or by purchase order, and a contract is formed when SysGene accepts it by sending a proforma invoice, an invoice or an order confirmation. Terms of Sale

SysGene sells to companies, research institutions and laboratories, not to individuals for personal use. Details of your organization or of the intended use may be requested before an order is accepted.

Yes. Larger quantities, custom packs, other grades and international delivery are quoted with delivered pricing.

Prices are given in the quotation: in Indian rupees for delivery in India, excluding GST, and in US dollars for delivery outside India, excluding import duties and local taxes. Prices on a quotation or proforma invoice are held for the period stated on it, which is 30 days unless stated otherwise.

Pay against the proforma invoice by bank transfer (NEFT or RTGS in India, international wire elsewhere), or against your purchase order where credit terms are agreed. Unless credit terms are agreed in writing, orders are dispatched once payment is received in full.

SysGene ships within India and to most other countries. Your quotation states the dispatch time for each item. After dispatch, delivery within India usually takes one to four business days, and international delivery by express courier usually three to seven business days, depending on the destination and customs clearance.

International orders are shipped DAP (delivered at place): the recipient pays import duties, taxes, brokerage and clearance charges, and is responsible for any import permit the destination country requires for biological materials. Shipping and Delivery Policy

Each product is packed to its released shipping condition: ambient; cold chain at 2–8 °C with refrigerant packs in insulated packaging; or frozen on dry ice. The shipping condition for each pack is shown on its product page. Temperature-sensitive shipments are dispatched early in the week wherever possible, so they are not in transit over a weekend. On arrival, frozen shipments should still contain dry ice and cold-chain shipments should still be cold.

You can cancel an order free of charge at any time before it is dispatched; made-to-order and custom products can be cancelled free of charge until production starts. Because the products are temperature-sensitive biological materials, returns of products delivered in order, or for change of mind, cannot be accepted.

Report shipments that arrive warm, thawed or without dry ice on the day of delivery, and anything else within five business days. If the problem is confirmed, SysGene replaces the product free of charge or refunds its price and the freight paid. Approved refunds are paid within seven business days of approval. Cancellations, Returns and Refunds Policy

Send an enquiry through the contact page, email info@sysgene.com for general enquiries or legal@sysgene.com for legal enquiries. The team responds within three business days.

Do not submit confidential sequence, construct or process information through the form; contact SysGene to arrange a secure exchange method.

Share the molecular format, function and quality requirements through the contact form, choosing “Platform evaluation”, and SysGene will assess the appropriate route. Do not submit confidential sequence, construct or process information through the form; contact SysGene to arrange a secure exchange method.