Development of clinical batches up to commercial

HALIX develops your processes within a GMP manufacturing framework

We have extensive knowledge of upstream and downstream techniques and equipment. This is the basis of our development experience. Key services in this area include:

  • Analytical Development
  • Process Development
  • Formulation Development
  • Freeze Dry (Lyophilization) Development
  • Pre-Clinical (Toxicology; Proof of Concept in Animal Models)
  • Engineering Batch Production

Clients can bring a process description based on either:

  • A small research lab scale
  • Their own developed processes

Based your information, HALIX develops the processes into steps. These steps are stable, efficient, well-defined and controlled. They are ready for scale, according to GMP manufacturing for (pre) clinical batches. Our experience with traditional equipment is as solid as our experience with disposable systems.

HALIX can look into modernizing processes that are currently carried out with traditional equipment. This scope may include

  • Shaking technologies (from the traditional shake flask to modern bioreactors)
  • Simple ultra-filtrations setups to complete aseptic processing

 

 

 

In more detail

 

Analytical Development

HALIX has many years of experience in process development. We are experts in supporting you during the realization of your product. We recommend taking part in the development of your project at an early stage. This enables full alignment on the next stages of analytical development. It is also critical for achieving long-term plans. Our development team specializes in the following product analyzes.

  • HPLC methods
  • 2D Electrophoresis
  • ELISA
  • Turbidity measurements

We also support the realization of an active pharmaceutical ingredient or a drug product.

 

Process Development

HALIX has many years of experience in process development. We are experts in supporting you with the realization of your product.

We recommend to Take part in the development of your project at an early stage. This enables full alignment on the next stages of analytical development. It is also critical for achieving long-term plans.

 

Recombinant Protein and Viral Vaccine Upstream and Downstream Development

We have extensive knowledge of upstream and downstream techniques and equipment. This is the basis of our development experience. Our clients can bring a process description based on

  • Small research lab scale
  • Their own processes

We will develop these processes into stable, efficient and controlled steps. These steps are scalable within a GMP manufacturing framework for (pre) clinical batches. HALIX also helps to select the right protein production systems. This optimizes your revenue and reduces the cost of goods.

The optimization of production media components is just as important. It can be determined by conducting approximately three lab scale trials. HALIX can look into modernizing processes that are currently carried out with traditional equipment. This scope may include

  • Shaking technologies (from the traditional shake flask to modern bioreactors)
  • Simple ultra-filtrations setups to complete aseptic processing

We have vast experience with the following host systems:

  • Mammalian (CHO, PERC6)
  • Bacterial (E.coli)
  • Yeast (Pichia) host systems

 

Formulation and Freeze Drying Development

Your purified drug substance might need to be (pre-) formulated and freeze dried. Our development specialists develop the best formulation. We also conduct freeze-drying cycles for your drug substance. We do this by committing to the following steps.

Step 1 - Technical transfer
During the technical transfer, we discuss the optimization of a formulation. While doing this, we also focus on the selection of excipients. The formulation is decisive for the final design of the freeze cycle.

Step 2 – Pilot-scale productions and engineer batch production
We test the designed process on a pilot scale, ranging from 5 ml to 1.000 ml. The GMP pilot freeze dryer lyophilizer is conforming with the freeze drying design. It is also cycle tested. We record and monitor the process by five product sensors and Pirani pressure measurements.

Step 3 - Evaluation
We report, evaluate and adjust the pilot run performance. We can guarantee you a stable process suitable for large scale GMP manufacturing.