Formulation & Drug Product Development

Starting with early-stage developability assessment and providing support throughout the entire formulation development life cycle, our services are suited for both large pharma corporations and early-stage companies alike.

We specialize in high protein concentration formulations of up to 230 mg/mL (utilizing the WuXiHigh^TM platform) and as low as 1.5 ug/mL. Additionally, we have significant expertise in the development of co-formulations and special modalities such as nanoparticles and liposomes in addition to the full range of traditional biologics and vaccine modalities that include:

• Recombinant proteins
• Monoclonal, bispecific and multispecific antibodies
• Antibody drug conjugates (ADCs) and other bioconjugates
• Fusion proteins
• Antibody fragments (e.g., Fab, scFv)
• Viral and virus-like particles (VLP) products
• Nucleic acids (e.g., plasmids, mRNA, oligos)  

Specialized services include but are not limited to:

• Early-stage developability assessment for candidate evaluation 
• Design of experiment (DOE) or one-factor-at-a-time (OFAT) experiments to identify the optimal formulation
• In-use compatibility studies to simulate and support clinical dose preparation, storage and administration in clinical setting.
• Shipping simulation and validation
• Extractables and Leachables (E&L) study
• Forced degradation and stability study
• High-throughput screening (HTS) utilizing biophysical methods such as dynamic light scattering (DLS), differential scanning calorimetry (DSC), and differential scanning fluorimetry (DSF) amongst other advanced analytical equipment and methods

High throughput formulation development platform for high concentration biologics drug products 

The WuXiHigh^TM platform provides customized biologics formulation development strategies for high concentration drug products (up to 230 mg/mL).  The platform can be applied to a variety of biological modalities, such as monoclonal, bispecific and multispecific antibodies, fusion proteins, and other recombinant proteins. Its distinctive viscosity reducers and synergistic excipient combinations enhance formulation stability and reduce viscosity. As an industry-leading high concentration drug product (DP) development platform, WuXiHigh integrates advanced computer simulation technologies like homologous modeling, molecular dynamics simulation, and machine learning. Through this integration, formulation development is achieved more efficiently and with less risk by leveraging computational simulation results, high-throughput experimental screening, and experimental verification.

To enable efficient protein characterization, the platform is equipped with high-throughput equipment including UNcle, HT-DLS, Rheosense, as well as novel technologies such as LF-NMR. WuXiHigh also offers tailored process development and technology transfer strategies for drug substance (DS) and drug product (DP) across a wide range of viscosities (up to 21.5 cP). Additionally, the platform facilitates the development, production, assembly and fill of prefilled syringes and autoinjectors. With a wealth of experience from over 70+ projects in high concentration formulation development and manufacturing, the platform has acquired significant expertise and a knowledge database, allowing us to provide comprehensive end-to-end formulation and drug product development services to our global clients.

Regardless of your development phase, our scientists design the ideal formulation that can be adapted for the container closure system (CCS) of your choosing. Ready-to-sterilize (RTS) and ready-to-use (RTU) vials in multiple sizes are available for liquid, frozen, and lyophilized dosage forms. For clients looking for specialized drug delivery systems, prefilled syringes (with or without NSD) and autoinjectors are also available.

Container Closure Systems Features:

• Vials in 2R, 6R, 8R, 10R, 14R, 20R, and 50R sizes with RTS and RTU configurations
• Prefilled syringes (PFS) in 1 mL long, 1 mL standard, 2.25 mL, 3 mL syringe with staked needle or luer lock design
• PFS with passive needle safety device (NSD) options
• Autoinjector products optimized for improved user experience
• Pilot, clinical phase and large-scale commercial GMP production for all CCS types

To expedite your path to clinical or commercial drug product manufacturing, our team of DP development experts support the drug product fill process development, scale-up and characterization using well established lab-scale models and full state-of-the-art analytical support.

Leveraging our advanced and automated fill line technologies, we offer a variety of process development and technology transfer services for process development for RABS (Restricted Access Barrier Systems), isolator-based filling lines, and fully-automated Vanrx systems including:

• Pilot scale (non-GMP) fill finish and lyophilization services for preclinical toxicology studies, non-GMP stability studies and scale-down process development
• End-to-end drug product fill process development from drug substance thawing through mixing, filtration, filling, stoppering and capping to final visual inspection.
• Lyophilization cycle development and optimization
• Container and closure selection and integrity testing

With the increasing number of patients with chronic diseases and growing trend in at-home healthcare, improved drug delivery solutions are becoming more vital to patient health and safety. Combination products such as prefilled syringes (PFS), PFS with needle safety devices (NSD) and autoinjectors offer greater convenience, operability and compliance to foster better patient outcomes.

WuXi Biologics Drug Product Development teams offer the expertise and state-of-the-art equipment to design and develop the ideal delivery systems for your intended purpose and technical specifications. Our combination product development services assessment and evaluation includes:

• PFS functionality
• Silicone oil distribution
• Dimensional measurements
• Container closure integrity
• Automated PFS GMP filling lines
• Design Control
• Safety devices and autoinjectors assembly

Prefilled Syringe & Prefilled Syringe with Needle Safety Device Options

Autoinjectors

WuXi Biologics works with well-established syringe and autoinjector vendors for combination product developers. For automated injectors (AI), our specialized team of our highly-trained scientists can evaluate:

• Standard design optimized for user experience
• Fully customizable based on client specific schematics
• Design optimized through AI selection, assembly, and human factor considerations

Using SOP-driven procedures, our drug product development group at the Center of Excellence (COE) for DP technology transfer works closely with our various DP GMP manufacturing teams to ensure smooth and efficient technology transfer from late-stage development into GMP production.

After technology transfer from our DP development team to our GMP operations, WuXi Biologics leverages its single-source process technology platforms and expertise to provide clients with efficient and cost-effective DP GMP manufacturing solutions. Our global GMP manufacturing facilities provide automated and isolator-based drug product production under current Good Manufacturing Practice (cGMP) conditions as defined by the worldwide regulatory agencies.  Our quality systems have been audited by 12 different global regulatory agencies and our various sites and GMP operations have successfully passed over 760 client quality audits.

We currently maintain 11 drug product GMP manufacturing facilities that in total provide an annual capacity of 100+ million vials and 30+ million PFS with options for GMP manufacture of all CCS types. In addition, multiple clinical and commercial drug product GMP manufacturing facilities in the U.S., Europe and China are being constructed to fulfill our client’s demands for clinical and commercial supply.

Throughout all stages of the drug product development lifecycle, starting from the development of First-in-Human (FIH) formulations through to late-stage container closure selection, final formulation lock and process validation, our analytical development teams support your DPD programs by utilizing state-of-the-art equipment and methodologies to provide all services in-house and to expedite your timelines. To see the full range of our comprehensive analytical capabilities, go here or contact us to learn more