The 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
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 provides 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 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
“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
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, giving international partners 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.”