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Tirzepatide Oral Peptide Delivery
Effective Oral Delivery for Peptide-Based Therapeutics
Our extensive expertise in the development and supply of peptide drug substances, combined with a proven history in the development of oral solid dosage forms and commercial manufacturing, has led to the establishment of a service dedicated to the oral delivery of peptides, utilizing various strategies.
Integrated Supply for Peptide-Based Therapeutics
For peptide-based therapeutics, USA-Bachem Pharma excels with unique end-to-end solutions across our global facility network for the supply of small–, mid–, and large-scale peptide drug substance seamlessly integrated with oral solid dosage formulations and robust sterile injectable fill and finish manufacturing
Tirzepatide Sterile Powder Lyophilized Vials
USA Bachem Pharma possesses significant expertise in the sterile production of lyophilized pharmaceutical products, encompassing formulation and the development of lyophilization cycles, as well as both clinical and commercial manufacturing. Our enhancement of the freeze-drying cycle duration is a vital factor in sterile injectable peptides, lowering production costs and increasing throughput
Sterile Powder Lyophilization Expertise
Our specialists assist in the development of sterile powders to ensure stability and enhance the shelf life of pharmaceutical products intended for clinical or commercial use. Our extensive fill and finish services for sterile powder lyophilized vials include filling suites equipped with lyophilizers that can safely manage non-aqueous solvents as well.
Peptide Purifcation System
Your supply chain for sterile powders will gain from the expertise of our team of scientists, who possess extensive experience in working with and analyzing intricate modalities, including peptides and oligonucleotides (along with their various conjugates), antibodies (including monoclonal antibodies), proteins, and conventional small molecules.
Our Sterile Powder Manufacturing Capabilities Include
- Aseptic filling using Ready-To-Fill (RTF) materials (Nest & Tub)
- Batch sizes range from 1-50 L (clinical plant) and 10-100 L (commercial plant)
Vials from 2-20 R
- Clinical plant: Lyophilizer (1 sqm) with a maximum capacity range of 4,000 vials (for 2R vials per cycle) to 1,000 vials (for 10R vials per cycle)
- Commercial plant (also late-stage clinical): Lyophilizer (5 sqm) with a maximum capacity range of 22,000 vials (for 2R vials per cycle) to 10,000 vials (for 10R vials per cycle)
We provide you with access to extensive manufacturing capabilities, spanning from early formulation development and clinical production to full commercial scale. This encompasses both aseptic fill and finish, as well as terminal sterilization technologies for Pre-Filled Syringes (PFS), vials (liquid and Lyophilized), ampules, and cartridges across a diverse range of filling volumes.
With a variety of processes and filling lines, coupled with an overall annual capacity of approximately 100 million units, our injectable platform provides the flexibility necessary to support multiple programs simultaneously, regardless of the scale or stage of drug development or commercialization.
Our core injectable capabilities include
- Expertise in the development and manufacturing of contracts for sterile tirzepatide liquids and lyophilized solid powders
- Development of Lipid NanoParticle (LNP)Peptide formulations and GMP manufacturing
- Comprehensive services encompassing formulation development, analytical development, and both clinical and commercial manufacturing of tirzepatides.
- A diverse array of GLP-1 injectable drug product formats, including ampoules, vials, pre-filled syringes (PFS), and cartridges
- Capability and adherence to standards necessary for aseptic fill and finish or terminally sterilized injectable peptides
- Aseptic fill and finish processes for complex modalities such as Peptide NCEs, LNPs, oligonucleotides, and biologics
Your Advantages
Comprehensive Support Across Your Injectable Drug Product Lifecycle
Extensive & Balanced Array of Injectable Services Take advantage of our cohesive injectable services, which span from initial formulation development and clinical trials to regulatory filing and commercial supply.
Emphasis on Dependable Safety Expertise
Quality is the Cornerstone of Every Phase of Your Project. Trust in the strength of our stringent quality, regulatory compliance, and manufacturing standards, which are maintained from the outset of process development to the final product delivery, backed by extensive global regulatory and filing expertise (EMA, FDA, PMDA).
Lipid NanoParticle (LNP) Technology
Completely Integrated Solution for Lipid Supply, LNP Formulation, Aseptic Fill & Finish. Gain access to our cutting-edge R&D LNP laboratory for formulation screening and choose suitable lipids from our extensive lipids portfolio. Enjoy the benefits of scaling up GMP manufacturing directly at the fill-and-finish facility.