In time and high-quality - for all of our services

HALIX provides tailor-made contract services to the biopharmaceutical industry

We support drug substance as well as drug product development and manufacturing. We do this through a comprehensive package of services in the following areas:

  • Protein production
  • Process development
  • GMP production
  • Analytical
  • Regulatory affairs
  • Supply chain management

Development

We have extensive knowledge of upstream and downstream techniques and equipment. This is the basis for our experience with process development.

Our clients can bring a process description based on a small research lab scale. Another option is a process description based on processes developed by the client.

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
 

Drug Substance Manufacturing

HALIX has built a dedicated BSL2 facility for drug substance manufacturing. It enables cell culturing upstream and purification downstream production.

Our spectrum of activities:

  • Tech transfer
  • Pre-culturing
  • Upstream product manufacturing
  • Downstream purification processing
  • Aseptic filling for clinical batches
  • Scaling up
  • Validation
  • Engineering
 

Drug Product Manufacturing

HALIX is a GMP accredited manufacturer of parenteral biologics. We produce clinical trial material for all major markets. We also produce according to EMA requirements. We have know-how in producing, filling and finishing:

  • Recombinant proteins
  • Virus vaccines
  • Injectables in general

Our spectrum of activities:

  • GMP Batch Production
    • Bulk Manufacturing
    • Aseptic Filling
    • Lyophilization
    • Visual inspection
  • Quality Assurance
 

GMP Services

From our own analytical laboratories, our skilled analysts deliver comprehensive analytical solutions. We support your drug substance (API) and drug product development programs. We also provide testing solutions for clinical and commercial drug product supply. These testing solutions can be analytical and microbiological.

Key services in this area include:

  • Release testing
  • Quality control
  • Stability tests
  • Batch Release and Certification
  • Label and pack
  • Randomization
  • Auditing of Suppliers
 

Supply Chain Management

We can ship pharmaceutical products to the market on a daily basis under EU rules. HALIX offers supply chain services ranging from purchasing goods, to manufacturing and shipping.

You can also use only part of our capabilities, like GMP storage.

Key services in this area include:

  • Replenishment
  • GMP Storage
  • Distribution
 

Regulatory Affairs

HALIX has built up extensive experience with IMPD for therapeutic vaccines and diagnostics. Our regulatory support specialists can help you create, file, register and maintain the dossiers.

Our spectrum of activities:

  • IMPD dossiers
  • Product registration
  • Product maintenance