Bioprocess Symposium «Passion for Bioprocessing» · 3 November 2026, Bern · free of charge Register ➜
Bioprocess Symposium «Passion for Bioprocessing» · 3 November 2026, Bern · free of charge Register ➜
Biotherapeutics — also known as biologicals or biologic drugs — are therapeutic products derived from living cells rather than chemical synthesis. They include monoclonal antibodies (mAbs), recombinant proteins, viral vectors, vaccines and cell-based therapies, all engineered to act with the molecular precision of natural biological systems. Their defining feature is structural complexity: while a small-molecule drug such as aspirin contains around 21 atoms, a typical IgG antibody is a multi-domain glycoprotein of more than 25,000 atoms whose three-dimensional fold and post-translational modifications are inseparable from its therapeutic function.
Because biotherapeutics are produced by living cells, the bioreactor provides the precisely controlled environment in which cellular processes can run reproducibly, making it the central enabler of safe, consistent, GMP-compliant biotherapeutic production.
Understanding biotherapeutics begins with their biology. Unlike small-molecule drugs, biologics rely on the natural language of proteins, cells and immune effector functions.
Mammalian Chinese hamster ovary (CHO) cells dominate therapeutic protein production thanks to their ability to perform human-like post-translational modifications, while microbial hosts such as E. coli and yeast are used for simpler proteins, peptides and viral vector components.
A therapeutic IgG antibody is built from two heavy and two light chains forming a Y-shaped molecule with two antigen-binding (Fab) regions and one effector-function (Fc) region. The Fab arms determine target specificity, while the Fc region governs immune mechanisms such as antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).
IgG antibodies carry a conserved N-glycan at asparagine 297 (Asn297) in the Fc region. Its composition directly modulates Fcγ-receptor binding, ADCC potency, thermal stability, half-life and immunogenicity — making glycan profile control one of the central goals of bioprocess development.
Productivity and product quality are governed by cellular parameters such as viable cell density, specific productivity and metabolic state. Bioreactor parameters — temperature, pH, dissolved oxygen, agitation and feeding strategy — are tuned to keep cells in their optimal physiological window.
Biotherapeutics manufacturing has evolved from traditional batch and fed-batch operations toward intensified, continuous and digitalised bioprocesses. The driving idea behind process intensification is biological: keep cells healthy and metabolically active for longer, at higher densities and closer to their physiological optimum.
Coupling a perfused N-1 seed bioreactor with a high-inoculation-density production stage delivers reported titer increases of approximately 85% and space–time yield gains over 130% in CHO-based mAb production.
Alternating tangential flow (ATF) and acoustic cell retention enable culture durations of weeks to months at very high cell densities, maintaining cells in a steady physiological state and improving product consistency.
Pre-sterilised single-use bioreactors reduce cleaning validation, shorten changeover and lower contamination risk, and have become a default for clinical-scale mAb, viral vector and vaccine production.
CRISPR-Cas9-based gene editing and AI-supported bioprocess modelling enable tailored production hosts and predictive process control, accelerating the path from clone selection to clinical manufacturing.
The Applikon bioreactor portfolio offered by Resea Biotec covers the complete development and production landscape for biotherapeutics — from early process screening in mini-scale vessels to large-scale GMP production in stainless steel systems. A consistent design philosophy across scales simplifies scale-up and ensures harmonised control of critical bioprocess parameters throughout the workflow.
| Bioreactor | Volume range | Vessel type | Operation mode | Application in biotherapeutics |
|---|---|---|---|---|
| Applikon MiniBio | 250 mL – 1000 mL | Glass (autoclavable) | Batch, Fed-batch | High-throughput clone screening, media optimisation, early process development for mAbs, recombinant proteins and viral vectors |
| Applikon Autoclavable Glass Bioreactor | 2 – 20 L | Glass (autoclavable) | Batch, Fed-batch, Perfusion | Bench-scale process development and scale-up for CHO-based mAb production, recombinant proteins and vaccine antigens |
| Applikon AppliFlex ST | 500 mL – 15 L | Single-use (3D-printed, pre-sterilised) | Batch, Fed-batch, Perfusion | Flexible, contamination-controlled workflows; seed train expansion; clinical-grade mAb, viral vector and vaccine production |
| Applikon Stainless Steel Bioreactor | Pilot to production scale | Stainless steel (CIP/SIP) | Batch, Fed-batch, Perfusion, Continuous | Large-scale GMP-compatible manufacturing of monoclonal antibodies, recombinant proteins, viral vectors and vaccines |
As biologic pipelines diversify beyond classic mAbs into bispecific antibodies, antibody–drug conjugates, cell and gene therapies and RNA-based therapeutics, manufacturing platforms must deliver greater biological flexibility, more reliable product quality and tighter control over cellular performance.
Cell line productivity and long-term phenotypic stability; consistent control of post-translational modifications such as glycosylation; bioprocess heterogeneity caused by gradients in dissolved oxygen, pH and shear during scale-up; and downstream bottlenecks created by intensified upstream titers.
Continuous and intensified bioprocesses — particularly N-1 perfusion and fully continuous upstream operations — are expected to become the new standard, supported by perfusion-adapted cell lines and advanced cell retention technology. Glycoengineering, synthetic biology and CRISPR-based host cell design enable tailored production cells with optimised metabolism, while AI-driven bioprocess modelling accelerates the timeline from discovery to clinical manufacturing.
Our specialists support you throughout the entire bioprocess lifecycle — from system selection and application design to implementation, optimization, and long-term operation. We work closely with you to ensure reliable, compliant, and scalable solutions tailored to your requirements.
Reach out to discuss innovative approaches for your project.
Biotherapeutics — also known as biologicals — are a broad range of biologically derived products used in healthcare to treat or prevent disease. They include monoclonal antibodies (mABs), which target specific diseases with high specificity; viral vectors, used to deliver therapeutic genes into target cells; and vaccines, which protect against infectious diseases. Each plays a pivotal role in targeted disease treatment and prevention.
Bioreactors are versatile tools tailored to the precise needs of biotherapeutic research and production. They allow for careful regulation of all critical parameters — including temperature, pH, dissolved oxygen levels, and agitation — ensuring the optimal environment for cell growth and product formation. Applikon bioreactors are engineered to support the complex needs of biotherapeutic production with precision, flexibility, and scalability.
Applikon bioreactors support the production of all major categories of biotherapeutics — including monoclonal antibodies (mABs) for oncology and autoimmune disease treatment, viral vectors for gene therapy applications, and vaccines for infectious disease prevention. The flexible configuration of Applikon bioreactor systems allows them to be adapted to the specific requirements of each biotherapeutic product type.
Resea Biotec bioreactors are designed to support biotherapeutic production at multiple scales — from early-stage research and process development through to small-scale production. Whether you are a researcher exploring a new therapeutic candidate or a company developing a biotherapeutic production process, our bioreactor technology provides the precision and scalability you need.
Resea Biotec offers a full-fledged consultation to help you identify the right bioreactor solution for your biotherapeutics process. Whether you are a researcher, entrepreneur, or industry professional, our state-of-the-art Applikon bioreactor technology and expert team can support you in exploring and innovating in the field of cell culture and biotherapeutics production. Contact us to get started.
