Clinical Manufacturing Services
Source: Kemwell Biopharma
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
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
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
- Solids
- Liquids
- Semi-solids
- Parenterals
- Biologics (proteins, peptides, monoclonal antibodies)
- First-in-Man Supplies
- Powder/API in bottle
- Powder/API in capsule
- Clinical packaging
- Bottles
- Blisters
- Tubes
- Sachets
- Vials
- Prefilled Syringes
- Wallet Cards
- Labeling
- Flexible/User friendly software (CLAPS) for the management of blinded clinical trial supplies
- 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:
Kemwell Biopharma Brochure
Kemwell Brochure
Kemwell Overview
Presentation: Kemwell: Biologics Becomes A Reality
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