Chemistry, Manufacturing & Controls

Atheln’s highly specialized scientists and technical experts can guide the CMC process from conception to commercial production

Chemistry, Manufacturing, and Controls (CMC) is the combination of scientific, technical and regulatory elements critical for successful product development with regulatory requirements increasing as the clinical development program progresses. Atheln’s highly specialized scientists and technical experts have extensive experience in the regulated markets and can guide the CMC process from conception to commercial production for the targets of interest and routes of administration:

  • Small molecules: NCEs, repurposed, prodrugs (expertise in synthesis, process development, scale-up, raw materials sourcing, GMP manufacturing)
  • Biologics: peptides, small proteins, mAbs, ADCs (antibody-drug conjugates), fusion proteins (expertise in cell line and process development, scale-up, materials controls, GMP manufacturing)
  • Cell and gene therapies
  • Injectable solutions, suspensions, sustained released formulations and implants (IV, SC, intracameral, intravitreal, subconjunctival), oral, topical, transdermal, episcleral
  • Combination products, including design and manufacturing of devices (expertise in compounding, extrusion, micro molding, injection molding)

Atheln experts design a clear road map from the initial stages of development (new chemical synthesis or biologic process) to managing scale-up, formulations and analytical development, and to GMP manufacturing the CTM (Clinical Trial Material) ensuring its quality, safety, potency and stability.

Early identification and management of risks is a critical focus of our experts when supporting early-stage companies creating innovative products of increasing technical complexity and unique regulatory challenges. Whether you need an entire virtual product development team to design the CMC strategy, identify the appropriate CMOs and manage the execution of all activities or only need to supplement a particular CMC discipline, our team becomes part of yours.

Atheln’s CMC services include:

  • Technical due diligence
  • Gap analysis
  • Design of an Integrated Development Strategy for all CMC activities
  • Process design / optimization and scale-up for small molecules, biologics and devices
  • Selection of critical materials and suppliers
  • Selection and management of CDMOs and contract laboratories
  • Formulation development and fill & finish / manufacturing of final dosage forms
  • Packaging and labelling
  • Analytical development and validation
  • Design of characterization studies using state-of-the-art analytical methods and evaluation of results
  • Design of stability studies for drug substance, drug product, devices, reference standards
  • Writing of CMC section for FDA and EMA filings as well as worldwide regulatory filings
  • Representing CMC in meeting with regulatory authorities