Protein Expression. Avoid a costly failed scale-up

Waving goodbye to antibody engineering and moving your lead candidates into transient protein expression is a big milestone in therapeutic antibody development. Usually you are in a rush. Time is money after-all.

But beware! 

Breakneck development can trip up drug developers, who are left with costly setbacks to fix before re-joining the race.

Now is your final chance to check your antibody. Get a sneak peek into the behaviour of your antibody. Is it worth risking an underperforming protocol or a misbehaving antibody?

Take a closer look at your antibody

We recommend running a pilot scheme before full scale up. This can help you: 

  • Validate procedures 
  • Avoid liabilities like fragmentation or glycosylation 
  • Identify issues related to immunogenicity and stability 

 You want to ensure you are scaling an antibody which you can actually manufacture! 

Think you know your molecule?

Having the ability to distinguish an ideal drug candidate from a dead-end molecule at this stage is an absolute must for a successful drug developer.

In this  example, the presence of multimers and aggregates, only identified by a more thorough analysis, skew the affinity results and mask a low quality preparation of antibody.

Deep analysis of function, purity and protein quality is therefore vital.

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Top 5 tips before you begin your transient protein expression

  1. Engineer your best chance of success
    Have you scrutinized your sequences for all liabilities and optimized for manufacturability?
  2. Optimize the transient protein expression protocol
    Make sure that your antibody is a close representative of an early-stage stable clone to take forward for manufacturing 
  3. Quality control as you mean to continue
    Quality and quantity are not mutually exclusive, but if forced to choose, we recommend going for quality every time.  
  4. Pilot your stability strategy
    Have you thought about how your antibody will withstand the shelf or storage? 
  5. Don’t overwork your cells
    We favour quality over quantity. This is partly because when high-yielding mammalian expression systems are pushed to the extreme, the quality of the antibody protein produced suffers. 

At Fusion Antibodies, we have been helping biotechs and pharma companies develop their antibodies since 2001. Through partnership with our clients, we take a holistic view of their antibody development focusing on the end result – developing an antibody which is manufacturable and more likely to make it to the clinic.

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