Project solutions

At Polpharma Biologics we don’t just offer fully integrated biopharmaceutical CDMO solutions but also complement this with expert IP, regulatory and clinical trial support.

By interacting with our drug development teams we become experts in your molecule and this gives us a huge advantage when designing clinical studies, it also significantly decreases the time it takes to get your biologic to the next stage.

Project solutions

Clinical support

We design, plan and report on pre-clinical and clinical trials. Our clinical operations team has decades of experience of overseeing all aspects of clinical trials to maximise the chances of a positive outcome and completion in the anticipated timeframe.

learn_more

Regulatory support

Our CMC and strategy regulatory affairs team provide unmatched support for clients during development of the medicine. The vast experience in our team in regulatory affairs and procedures gives us the ability to offer clear, independent and optimal advice on the ideal regulatory strategy.

learn_more

Project management

Project management is at the heart of our “We care” philosophy. We have a large team dedicated to ensuring that projects run smoothly and deliver on quality results on time. Our ultimate goal is always to ensure our partners` products reach the patient or next development step at the expected point in time.

learn_more

Other services

From idea to global supply. We care about getting your product to patients as quickly and safely as possible.

Mammalian solutions

Microbial solutions

Drug product & fill finish solutions

Biosimilar solutions

Project solutions

Mammalian solutions

All the component to take your product from DNA, through IND and clinical trials and to support your global commercial supply. This includes antibody discovery, cell line development, process development and cGMP manufacturing supported by extensive analytical capabilities.

Learn more

Microbial solutions

State of the art microbial manufacturing facilities for fermentation recovery & purification development through to cGMP manufacturing for preclinical, clinical and commercial supply.

Learn more

Drug product & fill finish solutions

Drug product development and cGMP manufacturing of sterile biologicals in liquid and lyophilized forms at lab and large-scale.

Learn more

Biosimilar solutions

Comprehensive biosimilar development capabilities from cell line development to commercial supply to help our partners provide patients access to the most advanced therapies available.

Learn more

Let’s collaborate and create quality biologics together.

Get in touch for more information.