CLB offers comprehensive DP services

Q&A with Dr. Yih H. Tan, Drug Product GM of Cheerland Biotechnology

Q1. What capability does Cheerland currently have in DP services?

Cheerland strives to build a leading one-stop CDMO services platform. We offer world-class expertise and experience in taking compounds from the earliest stages of development, all the way to successful commercialization, delivering speed-to-market and commercial success for our customers.

We leverage our broad range of capabilities and services at our sites in Shenzhen and Shanghai to support your program goals. The current aseptic manufacturing and sterile fill finish for biologics is a purpose-built, state-of-the-art high-speed isolator filling lines, with primary and secondary packaging, and labeling capabilities. Our fill-finish services include aseptic liquid filling in vials, lyophilization, pre-filled syringes and cartridges filling with corresponding automated inspection and leak detection. Our facilities are capable of manufacturing large commercial batch sizes with an effective performance of up to 18,000 vials/hour (2R) and 100% IPC of the filling weight.

Currently, we have dedicated buildings to house 4 custom-built filling lines. Two fill-finish lines with lyophilization capability. Each Lyo-line has two 25s.m. mass-production freeze dryers that can hold up to 200,000 vials / dryer (2R format). One fill-finish line for liquid fill, and a 3-in-1 multi-format line (prefilled syringes, cartridges, vials). ?Each of these filling line has it owns corresponding visual inspection, leak detection, and secondary packaging systems that can satisfy most packaging configuration according to the characteristics of the product and the needs of patients.

Q2. Can you highlight the main technical advantages in Cheerland integrating manufacture and DP?

When we design and build our facilities, Cheerland keeps a forward-thinking mindset to enable us to adopt digital technology to the manufacturing process of pharmaceuticals; and focuses on using data and analytics to drive efficiency and quality in production - Biomanufacturing 4.0 model.

We understand that our customers are looking for efficiency and would like get to the market faster. We have carefully identified and combined automation technologies and chosen vendors (locally and internationally) when building out the DP platform. With automation we can speed up the aseptic fill-finish and secondary packaging processes, enable real-time data collection from our equipment and this in turn enables us to continuously optimize our manufacturing processes. Automation also helps with the audit trail. As we are running production processes and developing batches, we can track all the information and document it in a more efficient way, thus allowing us to produce much faster whilst maintaining quality and lower cost.

Our DP platform enables us to track and trend equipment operating conditions, process controls, finished product specifications, and the associated methods and frequency of monitoring and control. By digitally connecting to our integrated Quality System, we gather the right data and metadata from batch creation all the way through to distribution, and upholding ALCOA+ principles.

Q3. In your experience what are the most common things clients need to consider in packaging?

Customers need to choose the right packaging material and configuration according to the characteristics of the product and the needs of patients. Factors to be considered include the sterilization methods and processes during production. Packaging materials should prevent confusion among different drugs and have traceability and the electronic supervision codes. Packaging needs to be able to ensure the safety and quality of drugs with sealing, durability, impact resistance and light shielding, etc. Cheerland provides holistic and diversified packaging solutions for fill finished vial, syringe, cartridge configuration, as well as high-tech anti-counterfeit packaging technology to meet client needs.

Q4. In terms of Drug Product, wat are the most common factors to consider in biosimilar DP?

Biosimilar DP should closely mimic the original DP’s requirements. ?Both share common and important SISPQ, such as:

• Safety, the drug is free from adverse reactions and toxic side effects;
• Stability, including but not limited to physical, chemical and metabolic stability;
• Quality Controllability, the ability to check the quality and the content of active ingredients and impurities.

Dosage forms should also be considered, including efficacy, expected dose, dosing regimen, stability of macromolecules, package compatibility, therapeutic target, route of administration, and cost. Therefore, there is no essential difference between biosimilar and original drugs in terms of formulation development, and they share a high degree of consistency and comparability.