Fully gowned laboratory scientist capping vials during monoclonal antibody manufacturing

mAbs and Recombinant Therapies

Symbiosis has a proven track record of supporting GMP aseptic fill finish for recombinant proteins and monoclonal antibody manufacturing.

Gmp biologics manufacturing technician wearing PPE holding up to the camera a vial of drug product.

Hundreds of projects to date

Over the past 40 years recombinant proteins have risen to become a core part of the therapeutic landscape. From relatively small hormones, to large and complex monoclonal antibodies (mAbs), the manufacturing process is now well characterised and well understood.

However, consideration must still be given to how the therapy will be delivered to the patient and therefore what the final product format will be.

Development Studies

Validations

Non-clinical / Engineering Batches

Clinical GMP Batches

PPQ & small scale Commercial Batches

Regulatory and Commercial Support

Row of sterile manufacturing scientists sat in a laboratory wearing PPE conducting visual inspection of drug product vials

Our experience

Symbiosis has extensive experience in delivering many hundreds of clinical projects related to mAbs and recombinant proteins. We can support your clinical trials.

Why Symbiosis?

Symbiosis are the leading fast access CMO for clinical or small scale commercial manufacture and our offering is built upon the following principles:

 

Availability

Waiting 6 or even 12 months for a filling slot can be detrimental. We work to your schedule and strive to have availability in as little as 8 weeks

Schedule

Delivering your product to the clinic on time is essential, given patients are often waiting. Therefore, we execute over 90% of projects within the agreed timeframe.

Speed

We understand the need for results is a critical factor in the progression of clinical trials. Our typical fill-finish campaign takes 12 weeks.

Experience and Expertise

Our dedicated team has handled >600 filling campaigns for mAbs to more challenging ATMPs for >100 customers. You are in safe hands.

Communication

Our service is underpinned by our expert project management team who will keep you informed every step of the way.

Flexibility

Drug development and manufacturing occurs in a dynamic environment. We work flexibly, where possible, to accommodate any changes that you may require.

mAb and Recombinant Protein Fill Finish Manufacturing Capabilities Sheet

 

Download our mAb and Recombinant Protein manufacturing capabilities sheet to find out more about how Symbiosis are well placed to support your mAb and Recombinant Protein manufacturing requirements.

 

Get access to the full resource

Fill-finish expertise in handling the most complex of products

We have extensive experience in taking precious, complex drug products from manufacture to QP release.

Have more questions?

Contact us to discuss how Symbiosis can help