Development of biopharmaceutical technology
Explore our powerful pharmaceutical and biopharmaceutical production application data, including traditional pharmaceuticals, monoclonal antibodies, gene therapy formulations, cell therapy formulations, antibody drug conjugates (ADCs), vaccines, and plasma products. Learn more about the application of next-generation biotechnology. Biotechnology startups can find faster and better solutions to tackle the most challenging development challenges and accelerate the path to commercialization.

Antibody drug coupling (ADC) technology uses monoclonal antibodies (mAbs) to deliver effective highly active pharmaceutical ingredients (HPAPIs) to target cells. Under the coupling form, HPAPI exhibits selective cytotoxicity, which can protect non target cells from toxic effects.

However, exploring the enormous potential of ADC technology is challenging and complex. In order to characterize molecules and demonstrate their purity, uniformity, and stability, advanced production kits and specialized equipment are essential. Effectively linking unique tumor targeted mAbs with cytotoxic small molecule drugs that effectively kill cells is just the beginning - to meet the needs of ADC production, a comprehensive product portfolio and extensive professional knowledge are needed in the development, production, and detection of small and large molecules.

For emerging biotechnology companies, understanding how to set expectations, where to seek support, and how to obtain startup resources can pave the way for faster and more efficient discovery, development, optimization, and commercialization of new therapies.

Therefore, we have designed this startup center to provide a central location for emerging biotech startups to access the various resources needed for project initiation and simplify the entire process from discovery to production, from financing and intellectual property protection to global regulatory compliance.

From monoclonal antibodies and recombinant proteins to advanced cell and gene therapies, our comprehensive products and services can accelerate your workflow, reduce risks, and help you reach the finish line faster. Whether you want us to do it for you, work with you, or help you do it yourself, we will ensure that things are done right from the beginning.

Biopharmaceuticals 4.0: Digitalization, Enhancement, and Continuous Bioprocessing

The growing demand for new therapies, the ongoing pressure to reduce costs, and the success of new models are driving the transformation of the biopharmaceutical industry. Whether it's the digitization of biotechnology, bioprocessing 4.0, or future biological manufacturing facilities, there are many goals that need to be balanced. To maintain competitiveness, emerging and mature biotechnology companies as well as C (D) MO need to improve speed, efficiency, flexibility, and scalability without compromising quality and compliance. On the basis of these requirements, greater value must also be provided and aligned with the sustainable development goals of the enterprise - all of which must be carried out in a highly regulated environment.

Digital Biomanufacturing: Evolution towards Future Facilities

Your digital transformation can accelerate the speed of global patient access to biopharmaceuticals. To ensure your success and help you achieve ambitious biomanufacturing goals in different modes and production scales, we offer an advanced, closed, end-to-end product portfolio ready for both upstream and downstream technologies. Combined with Process Analysis Technology (PAT), our data analysis, automation, and control software can drive digital maturity at the unit, factory, and enterprise levels.

Plasma fractionation plays a crucial role in the treatment of rare life-threatening diseases. Maintaining stable, consistent, and reliable performance is crucial for plasma component separation. To better serve patients worldwide, various challenges must be addressed: increasing production, maintaining process economy, and meeting growing regulatory requirements. Choosing suitable partners with a deep understanding of these challenges is crucial as it can provide plasma fractionation producers with new solutions and resource channels to improve the performance of their entire range of plasma products.

The commercialization of new cell therapies relies on the optimization of various aspects such as upstream and downstream processing, process development, testing, and production. Therefore, at the forefront of regenerative medicine, biopharmaceutical manufacturers require partners to have rich project experience and adaptability in the field of cell therapy product development and production. With thousands of high-end products and tools invested in it, any inefficiency may cause production bottlenecks and slow down the race against time. Therefore, every step of cell therapy production must adhere to strict quality and efficiency standards. To eliminate these potential bottlenecks in the commercialization process of cell therapy, it is necessary to optimize the cell therapy manufacturing platform, culture media and reagents, characterization tools, process development services, and testing plans.

With the increasing attention to special drugs and complex drug formulations, the production of drug products has become increasingly complex. In the development and production process of the final formulation, the processing and formulation of certain active pharmaceutical ingredients (APIs) may require special consideration. The bioavailability, stability, and low-dose formulation of active pharmaceutical ingredients in vivo are often obstacles that need to be overcome when introducing drugs to the market.

For the production of solids and liquids, complying with constantly evolving and increasingly strict regulations on excipient risk assessment is a challenge. Professional knowledge and understanding of global regulatory requirements can help ensure the compliance of chemicals, hardware, and consumables used in the production process.

For countless diseases and situations where patients have no hope of treatment or limited treatment options, gene therapy has unprecedented potential for treatment and cure. Currently, hundreds of gene therapies are being developed globally, with developers ranging from startups to long-standing industry leaders.

The successful development of gene therapy requires professional knowledge that is different from the production of other biological reagents (such as monoclonal antibodies). This model requires unique virus vector production and specialized testing capabilities, which are also the only two fields that can determine the success of candidate biological therapies. Due to the lack of mature process templates, changes in regulatory guidelines, and the need to accelerate project progress, gene therapy manufacturers face numerous difficulties in getting things right from the beginning.

Given the enormous opportunities and challenges brought by gene therapy, it is crucial to collaborate with experienced technology partners or contract development and production organizations (CDMO) to ensure successful process development, scaling up, production, and regulatory compliance.

The production of monoclonal antibody (mAb) therapeutic drugs adopts a template approach, and all steps from cell line development to finished product filling require powerful and scalable solutions. Enhancing process understanding has promoted the progress of monoclonal antibody production, achieving higher efficiency in upstream and downstream processes. These advancements in upstream have led to higher monoclonal antibody titers. With the increasing development of downstream purification operations, high concentrations of intermediate products from purification to formulation can be processed more efficiently. Closed one-time technology helps to reduce the carbon footprint of production, improve flexibility, lower costs, and improve quality.

Monoclonal antibody manufacturers adhere to the values of perseverance or sustainability, consistently striving to meet the increasing global requirements while controlling costs and maintaining flexible production for expanded clinical pipelines.

From early drug development to release, drug analysis and quality control (QC) that comply with international pharmacopoeia standards are crucial. Analytical chemistry and microbiological testing are crucial for ensuring the efficacy and safety of drugs.