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Our Formulation Development team offers services to develop customized formulations for different biologics, such as monoclonal antibodies, bi-specific antibodies, single-chain antibodies, nano antibodies, recombinant proteins, and fusion proteins . Key capabilities include filling process and formulation characterization (DoE), molecule developability and high concentration formulations.


  • Fast-track platform to support biologics’ developability evaluation.

  • Pre-formulation and formulation to support clone selection, process development and degradation pathways identification.

  • Rapid buffers and excipients screening by DSC, particle counting and/or spectrometry.

  • Container/closure selection and integrity test.

  • Filling process development, including freeze-thawing, dilution and mixing, holding times, filtration, filling rate and so on. Technical transfer and scale-up to support for GMP fill- & finish.

  • Long-term, accelerated, in-use stability and forced degradation studies will carried out base on the policy from ICH, ChP and so on.

  • Lyophilization process development.

Case Study

Ultrafiltration Approach Result

Ultrafiltration Approach Result

Buffer:20 mM His & His-HCl buffer, pH 6.0

Condition:adjust these samples to 10 mg/ml. Added 10 ml to a concentration tube (sartorius 30KD PES), and centrifuge it for 4000×g, each 5 min (flush the membrane by peptide for each timepoint). Tested the exchange buffer weight and concentration.

PEG-Induced Precipitation Result

PEG-Induced Precipitation Result

Buffer:20 mM His & His-HCl buffer, pH 6.0

Condition:concentrate these samples to 20 mg/ml. The resulting solution was spiked (10 µl sample)into the well containing 20 mM His & His-HCl buffer with varying levels of PEG to the final protein concentration of 1mg/ml. Then incubated overnight and inspection of appearance and concentration.

The challenge of high concentration formulation

The challenge of high concentration formulation

The viscosity, aggregation, self-association may increase due to the increasing of protein concentration, and may effect the below process steps.

Typical Formulation Workflow

Step 1

1~2 weeks

Developability Study

Bioworkshops Platform method

PEG-Induced, AC-SINS(Affinity Capture Self Interaction Nanoparticle Spectroscopy), e.g.

Step 2

12~24 weeks

Formulation Development


Excipient and Surfactant Screen

Formulation confirmation (3 Months)

Generate materials for pre-clinical development

Formulation Development Report

Step 3

3~4 weeks

GMP DP Manufacturing


Inspection & Package


Fully validated aseptic processing

Media Fill for custom primary packaging if need extra line to balance the text

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