Shun Luo, Founder, Chairman and PresidentThe science of biologics has never moved faster. Therapeutic modalities are multiplying, targeting is growing more precise and molecular architectures are becoming more complex. The discovery engine is running at full speed, but the path to manufacturing remains a bottleneck.
Manufacturing complex biologics with the consistency and cost required to reach patients broadly remains a challenge in pharmaceutical development. Most of the industry treats that problem as someone else’s.
Thousand Oaks Biologics was founded on the premise that manufacturing is where biologic innovation either scales or stalls.
“The competitive edge isn’t just at the innovation stage,” says Shun Luo, founder, chairman and president. “It will also be at the commercialization stage. And commercialization is manufacturing.”
That conviction shapes how Thousand Oaks Biologics is built. It is an integrated contract research, development and manufacturing organization (CRDMO). Its capabilities span the full arc, from early antibody discovery and cell line engineering to chemistry, manufacturing and controls (CMC) development, good manufacturing practice (GMP) production and commercial supply. Every capability is owned. Every stage connects. The system advantage is its molecule-first architecture, where every process is designed around the specific biologic it serves.
Begin Where the Biology Starts
How does control over cell culture media influence biologic production quality and yield?
Most biologics manufacturing organizations treat cell culture media as a given. Thousand Oaks Biologics built its entire platform on top of it.
Cell culture media provide the nutrient environment in which therapeutic cells grow and function. It governs not just how much protein those cells produce, but the folding, glycosylation and molecular properties that determine whether a biologic is safe and therapeutically active.
“As the saying goes, you are what you eat. If the media composition is flawed, no downstream process can fully compensate,” says Shun Luo.
Thousand Oaks Biologics operates the world’s largest serum-free cell culture media production base through its JSBio division. JSBio ranks number one among domestic cell culture media brands and number three globally, a position it has held for seven consecutive years. A proprietary cellular metabolism system formulates precise amino acid, vitamin and nutrient compositions to keep cells operating at sustained high output. The goal is to maintain both yield and product quality throughout the run.
That same metabolic science powers its ATF-based perfusion process. This continuous cell culture system keeps viable cells productive for a longer period and at far higher densities than conventional batch manufacturing. Efficiency can be improved by up to 10-fold for typical applications and up to 100-fold in high-density perfusion runs. Thousand Oaks Biologics is the only biomanufacturing company to have applied continuous perfusion technology at a commercial scale. Gains of that magnitude reshape the unit economics of biologics production by increasing yield per run and lowering the cost per gram of drug substance. Therapies that depend on sustained, high-density cell culture become manufacturable at scale, where conventional batch processes quickly reach efficiency and cost limits.
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The competitive edge isn’t just at the innovation stage. It will also be at the commercialization stage. And commercialization is manufacturing.
That same metabolic science powers its ATF-based perfusion process. This continuous cell culture system keeps viable cells productive for a longer period and at far higher densities than conventional batch manufacturing. Efficiency can be improved by up to 10-fold for typical applications and up to 100-fold in high-density perfusion runs. Thousand Oaks Biologics is the only biomanufacturing company to have applied continuous perfusion technology at a commercial scale. Gains of that magnitude reshape the unit economics of biologics production by increasing yield per run and lowering the cost per gram of drug substance. Therapies that depend on sustained, high-density cell culture become manufacturable at scale, where conventional batch processes quickly reach efficiency and cost limits.
A System That Compresses Time
In what way does integrated platform design accelerate biologics development timelines across manufacturing stages?
“We are not just providing cell line technology or upstream and downstream process technology,” says Shun Luo. “At every step, we have competitive technologies. But more importantly, we integrate everything from beginning to end. That is the system advantage.”
Integration brings speed and predictability. Across the industry, cell line development once took about 24 months. Incremental process improvements brought that down to about 12 months. Thousand Oaks Biologics compresses it further to seven to eight months by applying JSBio’s metabolic screening platform during the cell line selection stage. Identifying high-performing candidates earlier simplifies subsequent process optimization and delivers a cell line ready for CMC development and IND filing sooner than comparable platforms.
MeCHOta® CHO-K1, its proprietary cell line platform, drives that performance. It achieves expression levels of 6 to 9 g/L for monoclonal antibodies and 2 to 8 g/L for bispecific antibodies, both above industry averages. It operates without animal-derived components and holds certifications for sterility, absence of mycoplasma, absence of endogenous and exogenous viral factors, and cell line identification.
Thousand Oaks Biologics builds flexibility into the platform. A biosimilar targeting global markets may require multi-ton capacity for a single molecule. A specialized oncology therapy may demand rapid turnaround at a smaller scale with fast modality switching. Thousand Oaks Biologics structures its manufacturing configurations around these requirements, supporting modalities ranging from bispecific antibodies and antibody-drug conjugates (ADCs) to oligonucleotide and radioisotope conjugates. Its facilities include modular, disposable and reconfigurable systems designed to adapt as programs evolve.
Latecomers Can Build What Pioneers Cannot
To what extent do manufacturing design innovations improve stability and scalability of complex biologics?
Thousand Oaks Biologics entered the antibody-drug conjugate field in 2022, years behind the first-generation ADC manufacturers. It used those years to observe and refine its approach.
By the time its Shanghai ADC facility came online in August 2023, the industry had surfaced many of the modality’s most consequential manufacturing challenges. For instance, some of the earliest blockbuster ADCs had to be packaged in amber bottles because the compounds degraded under ordinary light, placing a burden on every clinician who prepared and administered the drug.
Thousand Oaks Biologics treated it as a manufacturing design problem and engineered stability into the production environment. Its conjugation and fill-finish suites incorporate full-spectrum light control. The drug arrives stable and clinicians can prepare and administer it using standard workflows.
That same design discipline runs through the facility. It was the first site in China to adopt and optimize intelligent Ligase Dependent Conjugation (iLDC) technology for commercial-scale ADC manufacturing. Single-use technologies handle potent cytotoxic payloads safely while protecting operators. The Shanghai site is now China’s largest commercial-scale ADC drug substance production base by capacity, spanning 14,759 square meters. It can process 60 antibody batches and 80 conjugation batches per year. It is supported by EU GMP-qualified persons, providing international partners with the regulatory assurance their most critical pipeline programs require.
ADC development begins before any facility is involved. Ginspire, its early-stage research platform, develops linker-payload technologies and provides antibody discovery, engineering and druggability assessment from the earliest stages of a program. For a client building an ADC from scratch, the entire pathway from discovery through commercial manufacture runs within one organization.
Partners, Not Projects
Luo describes Thousand Oaks Biologics as a partnership.
Biopharmaceutical development generates problems that standard service contracts are not designed to handle. Process deviations, unexpected stability data and mid-trial regulatory complications all require a manufacturing partner who treats a client’s molecule with the same urgency as its own. Some of Thousand Oaks Biologics’ client relationships have lasted over a decade, spanning discovery through commercial production.
The portfolio reflects that depth. Thousand Oaks Biologics currently holds three commercial-stage programs. One project cleared the National Medical Products Administration (NMPA) pre-approval inspection. A second completed its pre-approval inspection in the fourth quarter of 2025. It ranks second among third-party biopharmaceutical manufacturing service providers in China.
Shun Luo has more than 30 years of management experience and rejects the assumption that technical expertise and operational leadership are at odds.
“Scientists and engineers operate from knowledge and logic. They understand what can and cannot be done. They build systems that work, not systems that simply comply. At Thousand Oaks Biologics, the management structure runs on that principle from the top down,” says Shun Luo.
Thousand Oaks Biologics applies that principle across a manufacturing platform that controls every stage, from cell culture media to commercial fill-finish.
Discovery will continue to move fast. The question the next decade of biopharma will answer is not who can find the best molecules, but who can bring them to patients.
Life Sciences Review APAC recognized Thousand Oaks Biologics as the Biopharmaceutical CDMO of the Year 2026. A six-month cell line development timeline, China’s largest ADC production base and a commercial-scale perfusion platform all support that recognition.
“This is what we are building for,” says Shun Luo. “The next 10, 20, 50 years.”
Scaling Biopharmaceutical Manufacturing through Integrated CDMO Expertise
Biopharmaceutical innovation has expanded rapidly, yet manufacturing capacity and process complexity still shape how quickly therapies reach patients. Executives selecting contract development and manufacturing organizations face a landscape defined by complex biologics, accelerated clinical timelines and tighter regulatory scrutiny across regions. These pressures place manufacturing partners under closer examination, as development success now depends as much on industrial readiness as on scientific discovery.
Manufacturing scale remains a persistent challenge. Many emerging biologic therapies move from laboratory validation to clinical demand faster than supporting production systems can mature. Development programs often rely on fragmented networks of vendors for cell line development, process engineering and commercial manufacturing. Each transition introduces risk, adds technology transfer and regulatory uncertainty. Leading CDMOs reduce these friction points by consolidating expertise across the full chemistry, manufacturing and controls continuum, allowing programs to progress without repeated process redesign or duplicated analytical work.
Biologics manufacturing begins earlier than many organizations anticipate. Upstream decisions around cell culture conditions, media formulation and cellular metabolism shape both yield and structural quality of therapeutic proteins. Nutrient composition, amino acid balance and metabolic efficiency influence how cells grow and how consistently they produce monoclonal antibodies or recombinant proteins. Weak optimization at this stage can limit productivity and complicate purification. A strong CDMO demonstrates deep capability in cell biology and media design, not just downstream capacity.
Process efficiency now defines competitive execution. Traditional cell line development once required nearly 2 years before programs could progress toward clinical manufacturing. Development environments now demand shorter timelines without sacrificing product quality or regulatory compliance. CDMOs that combine biological insight with high-throughput screening and process modeling shorten development cycles while maintaining consistent expression systems. These gains translate into earlier clinical milestones and lower development risk.
Regulatory credibility adds another dimension to partner evaluation. Biopharmaceutical manufacturing operates under strict global standards, especially for programs targeting multiple markets. Certification under major regulatory frameworks signals that quality systems, documentation and production environments meet recognized expectations. Companies selecting a CDMO therefore assess not only technical capability but also whether partners maintain validated processes and audited facilities that build confidence among regulators, investors and commercial stakeholders.
Therapeutic complexity continues to increase. Antibody-drug conjugates and other advanced modalities combine biologics with highly potent payloads, requiring specialized containment, precise conjugation chemistry and strict environmental control. Production environments must handle sensitive compounds while protecting workers and preserving product stability. Flexible infrastructure that blends stainless-steel equipment with single-use technologies enables adaptability across modalities and production scales.
Strategic manufacturing partners deliver more than capacity. Sponsors benefit from organizations that combine biological insight, integrated process development and disciplined regulatory systems within a unified platform. These capabilities allow programs to move from discovery through commercialization without restructuring development strategy at each scale transition.
Thousand Oaks Biologics exemplifies this integrated approach to biopharmaceutical development and manufacturing. The company positions itself as an integrated CMC solution provider focused on large-scale, compliant biopharmaceutical production, with capabilities spanning CDMO services, cell culture media and early-stage research support. Its platform is built in part around advanced cell culture media development and cellular metabolism-guided optimization, shaping how biologic production systems are designed and improved. Its infrastructure extends from early discovery and molecular assessment to process development and commercial manufacturing, enabling programs to move through industrialization within a single integrated platform. Publicly presented capabilities cover upstream processing, downstream purification, formulation, ADC production and quality systems aligned with international regulatory expectations, including an EU QP Declaration for its Shanghai ADC manufacturing site. Thousand Oaks has expanded its ADC offering with production capabilities designed for product stability, operational safety and manufacturing flexibility. Combined with experienced technical leadership and a partnership-oriented delivery model, Thousand Oaks Biologics offers scientific depth and integrated manufacturing discipline for organizations advancing complex biologics toward global commercialization.
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Biopharmaceutical CDMO Info
Q1
What led Thousand Oaks Biologics to be recognized among top biopharmaceutical CDMO providers?
A fully integrated CMC platform has positioned Thousand Oaks Biologics Inc. as a recognized Biopharmaceutical CDMO. The company delivers end-to-end services spanning cell line development, process optimization, analytical testing and commercial-scale manufacturing. Its ability to support biologics such as monoclonal antibodies, vaccines and cell therapies within a single framework reflects strong technical depth and operational scale. This integrated model enables efficient transition from research to production, reinforcing its standing as a Biopharmaceutical CDMO.
Q2
How does Thousand Oaks Biologics differentiate its approach to CDMO services?
A vertically integrated and innovation-driven model defines how it delivers Biopharmaceutical CDMO services. The company combines proprietary cell culture media development with manufacturing and analytical capabilities, allowing tighter control over quality and scalability. Its focus on building a self-sufficient supply of key raw materials and process components enhances consistency and reduces dependency on external suppliers. This level of integration distinguishes its Biopharmaceutical CDMO offering from fragmented service providers.
Q3
How does the company support clients across drug development stages?
Lifecycle support is central to its Biopharmaceutical CDMO services. It works with partners from early-stage discovery through clinical trials and into commercial manufacturing, providing services such as molecule design, process development, scale-up and regulatory support. By offering a continuous “bench-to-market” pathway, the company helps streamline development timelines and reduce technical transfer challenges between stages.
Q4
What value do its CDMO services bring to biopharmaceutical development?
Efficiency, cost control and scalability define the value of its Biopharmaceutical CDMO model. By integrating development and manufacturing under one platform, the company reduces duplication of effort and accelerates timelines. Its capabilities in large-scale, GMP-compliant production ensure that therapies can move from clinical phases to commercialization with consistent quality. These advantages make its Biopharmaceutical CDMO services highly relevant for companies seeking faster and more reliable development pathways.
Q5
What role do expertise and technology play in its platform?
Advanced bioprocessing expertise and continuous innovation drive its Biopharmaceutical CDMO capabilities. The company applies technologies in cell culture, purification and analytical development to support complex biologics. Its focus on emerging modalities such as antibody-drug conjugates and recombinant proteins reflects a commitment to staying aligned with evolving therapeutic trends. This integration of expertise and technology strengthens the reliability of its Biopharmaceutical CDMO services.
Q6
Why is Thousand Oaks Biologics relevant to current biopharma industry needs?
The growing complexity of biologics and demand for scalable manufacturing have increased the importance of integrated partners, and Thousand Oaks Biologics addresses this through its Biopharmaceutical CDMO platform. Its ability to combine early research, process development and global manufacturing within a single ecosystem aligns with the industry’s need for speed, compliance and cost efficiency. By supporting diverse biologic modalities and global regulatory requirements, the company remains closely aligned with modern biopharmaceutical development needs.
