Technology Transfer and Clinical Trials Application
Hanxin Pharmaceuticals has a well-established R&D and project management team that can efficiently facilitate the transfer of methods, analytical techniques, and processes. We ensure a smooth transition between research and commercial production through document materials, video conferences, on-site guidance, and other means. We also provide the necessary documentation for clinical trial applications to ensure a successful clinical submission. Construction of bacterial strains bank Construct engineering bacteria that meet the specifications based on customer requirements. Establishment and validation of a three-tier bank. Includes the establishment of research seed bank, primary seed bank, and working seed bank. Testing involves evaluating plasmid loss rate, expression level, and stability of transgenerational and storage to ensure the stability of bacterial strains. Process development and optimization Upstream Process Upstream Process R&D Laboratory at Hanxin Pharm has a series of microbial cultivation systems and various advanced process analysis technologies, providing development services including clone design, clone screening, culture medium optimization, and reactor process control strategy optimization to enhance expression levels and process robustness. The high talented team and advanced platform are simultaneously able to handle multiple process development projects, and undertake projects starting from any development stage. Downstream Process Downstream Process Development at Hanxin Pharm is committed to small-scale purification process development, process parameter optimization, and process scale-up of recombinant protein drugs. It can achieve the capture, intermediate purification, and refinement of various proteins expressed by different recombinant protein expression systems (prokaryotic expression systems, yeast expression systems, and mammalian cell expression systems, etc.). R&D Services: Development and optimization of various chromatography purification processes, scale-up studies of various chromatography processes, screening of chromatography fillers, dynamic load capacity determination, filler life and cleaning studies, separation and purification of over-limit unknown impurities, labeling and standardization, preparation of recombinant protein samples, virus inactivation, virus removal filtration process development, risk and cost-benefit evaluations for various purification process unit operations, etc. Formulation Research Hanxin has rich experience and expertise in protein drug process formulation, and can provide R&D services for injection and tablet formulations, including excipient selection, compatibility studies, prescription and process research. Small-scale and Pilot-scale production
Six microbial recombinant drug manufacturing workshops.
Manufacturing capacity of more than 600 kg/year.
Total area of 12,000 square meters.
GMP standard manufacturing of microbial recombinant drugs from grams to kilograms.
Equipments: 1000L-5000L fermenters, 1000-10000L reactors, disk centrifuges, high-pressure homogenizers, ultrafiltration machines, protein chromatography systems, and low-pressure chromatography columns (200-1200mm), high-pressure chromatography systems, and high-pressure preparative columns (100-600mm), Class A explosion-proof reactors, deprotection tanks, crystallization tanks, freeze dryers, etc.
 Professional Support Extensive expertise in peptide therapeutics field.
SPPS, LPPS, fragment condensation.
Conform with all protection measures (Boc, Fmoc, Cbz).
Innovative purification and separation techniques.
Process development and scale-up capabilities to ensure stable commercial manufacturing processes.
Complex peptide sequences and peptide modifications in large-scale manufacturing.
Capacity Two peptide synthesis manufacturing workshops. Manufacturing capacity of grams to hundreds grams of peptides under GMP conditions. Equipments: PSI 500 pilot-scale peptide synthesizer, peptide synthesis reactors, amino acid-specific activation reactors, peptide cleavage reactors, high-capacity low-temperature high-speed centrifuge, high-pressure chromatography system, and high-pressure preparative columns (100-600mm), freeze dryer, etc. Services
Method development and validation.
Stability studies: forced degradation studies, accelerated and long-term stability studies in GMP environments.
Purity and content determination, residual solvents, water content, cation content, anion content, aggregation content, elemental impurities.
Microbiological research: biological burden for endotoxin limit and quantification, microbial limit tests, microbial identification, and strain typing.
Amino acid analysis and enantiomeric purity: LC-MS analysis after acid hydrolysis and derivatization to accurately evaluate the amino acid composition and D-isomer impurities in the peptide sequence.
Identification through peptide mapping: enzyme digestion followed by LC-MS analysis to characterize and confirm the API.
Identification through molecular weight and sequencing: 2D HPLC coupled with Q-TOF and MALDI-TOF/TOF HRMS for accurate MW and sequence determination.
Project management
Dedicated project management team monitoring all aspects of client projects and coordinating communication and interaction between the project team members and customer, ensuring timely delivery and reaching cost objectives.
To facilitate communication and interaction throughout the entire project process, the customer team are able to be present on-site during technology transfer, to assist the project progress at critical stages.
Hanxin strictly adhere to pharmaceutical manufacturing quality management regulations to ensure consistent and stable high-quality products.
Equipped with advanced instruments, equipment, facilities, and a robust quality management system to ensure strict monitoring of research, manufacturing, and services, to meet USP, CP, EP standards.
Drug research quality control Hanxin Pharmaceuticals has extensive experience in method development using various analytical techniques such as chromatography, mass spectrometry, spectroscopy, etc., to effcieintly support customer needs for drug development and manufacturing testing. Hanxin provides experimental design for method development, progress reports, method validation protocols, and validation reports. Morever, Hanxin undertakes method optimization, method transfer, and establishment of quality standards. RLD Selection and analysis for generic drugs or biosimilars.
Selection of the Main excipients used for formulation development.
Optimization of manufacturing process parameters based on Quality by Design (QbD).
Packaging selection.
Conducting compatibility studies on drug combinations, including evaluation of dilution effects and compatibility studies with injection devices.
Hanxin Pharm provides a full range of formulation development services for various innovative and generic drugs, including conventional injectables, special sustained-release injectables, immediate-release/controlled-release solid formulations, and topical formulations. The specific services include (but not limited to) providing formulation-related development support and APIs manufacturing process development services. |
