Product/Service

Clinical Manufacturing Services

Source: Kemwell Biopharma

Clinical Manufacturing Services
Kemwell offers clinical manufacturing from lab-scale to commercial, in a wide range of pharmaceutical drug product dosage forms for both small molecule and large molecule.

Click Here To Download:
Kemwell Biopharma Brochure
Kemwell Brochure
Kemwell Overview
Presentation: Kemwell: Biologics Becomes A Reality

Kemwell offers clinical manufacturing from lab-scale to commercial, in a wide range of pharmaceutical drug product dosage forms for both small molecule and large molecule. Our cGMP facilities in India & Sweden produce products for clinical and commercial supplies in multiple markets, including North America and European markets.

Core Expertise:

  • cGMP manufacturing through phase I, II & III
    1. Solids
    2. Liquids
    3. Semi-solids
    4. Parenterals
    5. Biologics (proteins, peptides, monoclonal antibodies)
  • First-in-Man Supplies
    1. Powder/API in bottle
    2. Powder/API in capsule
  • Clinical packaging
    1. Bottles
    2. Blisters
    3. Tubes
    4. Sachets
    5. Vials
    6. Prefilled Syringes
    7. Wallet Cards
  • Labeling
    1. Flexible/User friendly software (CLAPS) for the management of blinded clinical trial supplies
    2. CFR 21 part 11 compliant system
  • Comparator Development, including Over-Encapsulation
  • Placebo Manufacture
  • Cleaning Verification
  • QP Release (Sweden)
  • Dosage form development and blinding
  • Storage & Distribution
  • Returns, Reconciliation, and Destruction

Facilities:

  • cGMP pilot plant produce tablets and capsules from a batch size of 0.5 – 100 Kg
  • Process development and scale-up to 1000 kg
  • cGMP aseptic manufacture of small & large molecules with batch sizes of 1L – 2000L for vials & pre-filled syringes
  • Click Here To Download:
    Kemwell Biopharma Brochure
    Kemwell Brochure
    Kemwell Overview
    Presentation: Kemwell: Biologics Becomes A Reality