Are your biopharmaceutical process development facing these bottlenecks?

Time-consuming cell line development: Traditional methods take 5-6 months, while competitors have advanced to AI-driven 3-week screening

High process scale-up failure rate: From 3L to 2000L scale, critical parameter deviations lead to batch scrapping

Intensified compliance risks: FDA adds 47 CMC review points in 2024 (monoclonal antibodies account for 65%)

Out of control production costs: downstream purification yield is less than 60%, with annual losses exceeding $8 million

5 technological revolutions in end-to-end biopharmaceutical development processes

​Cell line development: HyperCLD™ AI platform, clone screening time shortened by 82%, titer ≥ 8g/L

​Upstream process: IntelliFeed intelligent feeding system, cell density exceeds 150×10⁶ cells/mL.

​Downstream purification: ChromaXpress continuous chromatography technology, yield increased to 88%, HCP <1ppm.

​Formulation development: StabilizePro formulation optimization algorithm, liquid stability ≥36 months (2-8℃).

​Technology transfer: QbD-driven process scale-up model, 100% success rate, PPQ batch passed once.

7 reasons why the world's top 10 pharmaceutical companies choose us

1. A disruptive breakthrough in cell line development

AI prediction model: Based on 20,000+ sets of historical data training, the accuracy of predicting high-expression clones is 92%

Automatic clone screening: laser microdissection + single-cell imaging to ensure monoclonality (PDA TR88 compliance)

Case: A bispecific antibody project achieved a titer of 9.2g/L (competitors average 5.8g/L)

2. Black technology for upstream process optimization

Metabolomics real-time monitoring: Detect 60+ metabolites every 15 minutes and dynamically adjust the feeding strategy

Patented culture medium formula: no animal-derived ingredients, batch-to-batch CV<3%

Data support: Compared with traditional processes, VCD increased by 40% and lactic acid accumulation decreased by 75%

3. Revolution in downstream purification efficiency

Continuous flow chromatography technology: 70% reduction in resin usage and 50% saving in plant area

Virus clearance verification package: covers X-MuLV, MMV, etc., LRV≥4.5 log10

​Cost comparison: Monoclonal antibody purification cost 18/g (industry average 26/g)

3 major traps that must be avoided in the process development of biopharmaceuticals

​1. Blind spot of cloning stability

Required: at least 80 generations of stability data (ICH Q5D standard)

Our solution: accelerated stability model (verification at 40℃/75% RH for 6 months is equivalent to conventional 24 months)

​2. Process change out of control

Beware: Critical quality attribute (CQA) deviation leads to clinical data invalidation

Our guarantee: QbD design space is locked, and the accuracy of change impact prediction is ≥95%

​3. Supply chain interruption crisis

Must verify: dual supplier strategy for key consumables (such as chromatography fillers)

Our advantage: Establish a strategic reserve with Cytiva and Pall to ensure 6 months of emergency supply