Recombinant Protein Production Services

Custom protein production utilizing mammalian cells, E. coli, and insect cells, producing high-quality proteins at industry-leading speeds.

Recombinant Protein Production Services

Uniting Drug Development Expertise with Protein Production Excellence

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WuXi Biologics’ industry-leading Protein Sciences (PS) Department specializes in the development and production of monoclonal, bispecific and multispecific antibodies, fusion-proteins, cytokines, enzymes and other biologics. Our team of experts can support the preparation of the most complex proteins to provide one to hundreds of standard antibodies and proteins for your diverse needs. Projects can be structured by either a FTE (Full Time Equivalent) or FFS (Fee For Service) model to meet your project needs. Our labs feature high-throughput expression and purification systems to maximize efficiency.

WuXi Biologics Protein Sciences

Expedited 777 Mammalian Transient Production Service for Standard mAbs such as IgG

Mammalian Platform Features

• CHO, HEK293 cell lines for antibodies and non-antibodies such as Fc-fusion proteins and His- or Flag-tagged proteins • Engineered CHO cell lines for glycan modulation of antibodies and proteins • NS0 cell line is well suited to produce hard to express proteins such as cysteine rich proteins; successfully delivered hundreds of challenging proteins which failed in other expression systems • Offer developability studies that deliver data that is highly representative of eventual large-scale production processes • Automated expression, purification, and analytics • Offer CMC-like process providing highly-representative developability study results for therapeutic products

Standard Antibody Production Platform 7 Days Gene synthesis VH & VL segments

7 Days

Expression

5-5,000 mg

>95% purity 2-step purification

7 Days

Purification & QC

These timelines represent the typical turnaround time for a regular monoclonal antibody. More complex molecules such as bispecific antibodies, Fc-fusion proteins, and other recombinant proteins usually have longer timelines.

WuXian TM Transient

Timeline 3-5 weeks

Average Yield (CHO)

Expression Volume

2.2 g/L

1 mL to 20 L

WuXian TM Express

Timeline 6-7 weeks

Average Yield (CHO)

Expression Volume

3.5 g/L

20 mL to 25 L

WuXian Transient and WuXian Express Platform Features: • Projects start from customer-provided amino acid sequence (with codon optimization), DNA sequence, or plasmids • Deliver high-quality products after 1-2 purification steps suitable

for most in vitro and in vivo studies • Provide comprehensive QC data

Process Cell free E. coli

Timeline 2-3 weeks 2-4 weeks

Soluble protein production Inclusion body and refolding production

Non-Mammalian Platform Features

4-6 weeks

• High-throughput protein refolding condition screen • Screening and engineering of GPCR constructs • Easy to scale-up process for manufacturing • Development of multi-step, non-tag protein purification method

E. coli Platform Features: • Projects start from customer-provided amino acid sequence (with codon optimization), DNA sequence, or plasmids • Deliver product and QC data after multiple purification steps • A toolbox for hard-to-express targets, including host strains, cultural conditions, and plasmid designs • High-throughput screening for evaluation of protein refolding conditions (over 200 refolding conditions established) • Cell-free expression system available for the screening of hard-to-express proteins and various mutants

Process Insect Bac-to-Bac

Timeline 4-6 weeks 3-5 weeks 3-4 weeks 5-6 weeks

flashBac

E. coli Strain Engineering: • Optimizes the purification of desired proteins

S2 transient S2 stable pool

LC/MS results showing before and after purification of  a GeneX-deficient protein and elimination of GeneX contamination Case Study: Engineering of E. coli HCP Free Strain

Insect Platform Features: • Projects start from customer-provided amino acid sequence (with codon optimization), DNA sequence, or plasmids • Deliver product and QC data after multiple purification steps • Multiple insect production cell lines available, including:  Sf9, Sf21, HighFive, ExpiSf9, Drosophila S2 cell, with flexible transfection strategies (classical Bac-to-Bac, flashBac, S2 transient, and stable pool) • Experience working with challenging molecules like membrane proteins and tag-less proteins requiring, for example, screening and reformation of GPCR mutants or development of multi-step purification processes from scratch • Expertise available for reconstitution of membrane proteins into nanodiscs

BL21

x10 2 1

+ESI Scan (4.848 - 6.214 min. 83 scans) Frag=200

25853.33

0.8 0.6 0.4 0.2

20853.11

36478.08

49085.14

0

20,000

30,000

40,000

50,000

Counts

BL21 GeneX-deficient

x10 4 4 3.5 3 2.5 2 1.5 1 0.5 0

+ESI Scan (5.785 - 6.087 min. 20 scans) Frag=200

25.854.18

10,000

20,000

30,000

40,000

50,000

Counts

Industry-Leading Timelines

Elite Quality

We offer industry-leading timelines from gene synthesis to shipment of your product based on the quality and quantity of protein requested.

• Proprietary codon optimization algorithm generates higher expression and improved protein quality on WuXian Platform • Multiple cell lines and cell culture processes offer more solutions for optimization of product quality • Same vector system and host cell line for transient and stable transfection ensures consistent quality across all production platforms • High-throughput automated expression, purification, and analytic systems • Unique protein production toolbox for bispecific/multispecific antibodies to ensure successful delivery with outstanding efficiency

Timeline 2-7 weeks 3-10 weeks

Quantity unlimited unlimited

Product

Regular antibody

Bispecific/multispecific antibody

COVID-19 antibody expression and purification Completion of COVID-19 antibody IND application

8 days

gram-level

2.5 months

unlimited

In special expedited scenarios (e.g., COVID-19/pandemic emergency production), we can deliver gram level quantities of antibody in 8 days or less! For most recombinant proteins, depending on scale and scope of  the production required, the timelines represented here may apply contingent upon protein expression in our cell lines.

WuXi Biologics Protein Sciences

Equipped with the industry-leading expertise, extensive experience, state-of-the-art facilities and proprietary technologies, WuXi Biologics’ PS Department offers our customers the high-throughput, high titer and high purity antibody and protein production for a variety of applications, including but not limited to antibody drug development, small molecular drug targets, animal health, as well as agriculture. With a commitment to innovation and quality, WuXi Biologics’ PS Department is well-positioned to support the growing demand for

Unlimited Capacity

Extensive facilities, high-throughput equipment,  and highly-trained staff available to deliver: • 5,000+ proteins delivered each year • 2,000+ bispecific antibody product experience • 3,000+ antigen product experience • Fast response and immediate initiation of your projects (after receiving AA/DNA sequence) • Diversified expression platforms, including mammalian, E. coli , insect, and yeast • FTE-based service models

antibodies and recombinant proteins services. Our track record of success and strong reputation in the industry make us a trusted partner for clients around the world.

About WuXi Biologics

WuXi Biologics is a leading contract research, development and manufacturing organization (CRDMO) that provides end-to-end capabilities to healthcare organizations worldwide. With operations in China, the United States, Ireland, Germany, and Singapore, we enable our partners to effectively and efficiently bring biologics and vaccines to patients worldwide through our comprehensive and high-quality drug development model.

wuxibiologics.com | info@wuxibiologics.com The world’s leading global single-source platform from concept to commercialization.

5-9-2024

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