Drug Products

Take your project to the next stage of drug product development with CARBOGEN AMCIS

CARBOGEN AMCIS has developed a comprehensive range of services for the formulation of New Molecular Entities (NMEs) and the reformulation of existing drugs. With a specialization in developing sterile and pyrogen-free parenteral formulations for preclinical and clinical trials (phases I, II and III), CARBOGEN AMCIS is your partner of choice for complex and demanding products, that require the highest levels of quality in our industry.

With over 15 years of experience, we have gained the necessary skills to safely develop injectables and liquid pharmaceutical forms, for a wide range of indications and varied drug delivery systems. Much of our recent experience is in the area of highly potent and antibody drug conjugates (ADC), addressing the oncology sector. Our disciplined and experienced personnel operate with state-of-the-art containment equipment; within facilities that are certified to manipulate materials of the highest occupational exposure (single-digit nanogramme levels), including cytotoxics and cytostatics. Our customer support capabilities for drug products span from pre-formulation and formulation services, to asceptic production of clinical batches. Our formulation capabilities are an integral element of CARBOGEN AMCIS’ API process, research and manufacturing services for rapid supply of product into clinical trials.

It's rewarding to be able to help manage projects and to watch them develop into the production stage successfully. Each project is unique so you're faced with new challenges to overcome each day which breaks up the daily routine.

Emmanuelle - Pharmaceutical Development Project Manager, Riom

Pre-formulation

Our skill-sets include:

  • The physico-chemical characterization of the API
  • The selection of the best crystalline forms and definition of the stability profile of the material

We routinely provide Comprehensive pre-formulation work, integrated analytical and solid state services developed to provide critical information to inform on the optimal formulation strategy of drug substances, in both solution and solid states.

  • Feasibility and pilot studies for dispensing microdosing and particle size distribution
  • Bioavailability studies: dissolution, disintegration testing and solubility testing (simulation in physiological conditions)

More than

15

years

of experience in fill & finish

Approximately

50

percent

of projects are HiPo formulation

Formulation Development

Our skill-sets include:

  • Injectables
  • Highly potent drugs and biological products

A full suite of formulation and process development capabilities for parenteral forms; including small molecules, cytotoxics, proteins, peptides, enzyme inhibitors, antibiotics (nonbeta-lactam), vaccines (non-live), mAbs and antibody drug conjugates (ADC), providing:

  • Formulation of new products and optimization of existing formulations
  • Development and optimization of lyophilization cycles
  • Process development and scale-up - for liquid or freeze-dried injectables

Sterile Production

Our skill-sets include:

Pre-clinical Batches

  • Technical, stability or toxicology

Clinical Batches

  • Phase I, II and low volume phase III
  • Validation of aseptic process via media fill testing
  • Confirmation of the clinical batch: QP on site

Current Good Manufacturing Practices (cGMP) services for the fast supply of preclinical and clinical batches of liquid or lyophilized parenterals. Aseptic filling in a wide range of volumes in vials, syringes and cartridges; from one milliliter to several hundred milliliters.

Key Services:

  • Preclinical batches and clinical batches (phases I, II and III)
  • Validation of aseptic process (media fill testing)
  • Process development and scale-up
  • Class A (ISO 4.8) sterility

Designed for liquid or freeze-dried injectables.

For more information
download our Development & Aseptic Production of Drug Products
brochure or contact us today.

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CARBOGEN AMCIS is a leading service provider, offering a portfolio of drug development and commercialization services to the pharmaceutical and biopharmaceutical industries at all stages of drug development. Our integrated services for Drug Substances (DS) and Drug Products (DP) provide innovative solutions to support timely and safe drug development.

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