Signed in as:
filler@godaddy.com
Signed in as:
filler@godaddy.com
Cagrilintide is a long-acting amylin analog that works by mimicking the actions of the natural hormone amylin, which is co-secreted with insulin. It acts on amylin receptors and the calcitonin receptors to reduce food craving and increase satiety. Oral bioavailability is a key attribute of a peptide drug candidate and a significant challenge in peptide development.
Approximately 70-90% of New Molecular Peptide Entities in today’s peptide pipeline are poorly absorbed, which complicates their delivery and results in poor bioavailability. Oral Semaglutide enhanced with SNAC has received FDA approval, and the combination of Cagrillintide and Semaglutide oral peptide delivery is next in line to receive FDA approval. This is where USA-Bachem's expertise in oral delivery entity manufacturing comes in to strengthen the delivery of these combined peptide moieties orally, without the pain associated with injection sites.
NAD stands for nicotinamide adenine dinucleotide, a crucial coenzyme found in all living cells that plays a vital role in various metabolic processes. NAD is essential for energy production, DNA repair, and cell signaling. Its levels decline with age, and research suggests boosting NAD could be beneficial for health and potentially slow down aspects of aging. All USA-Bachem oral solid peptide delivery products contain NAD+ as the base, along with lipid-based drug delivery systems, to enhance peptide bioavailability and overall well-being. We create health!
Early Phase CagriSema oral peptide innovation formulation faced challenging properties, such as peptides with limited solubility, permeability, a very low
drug load, high potency, and limited stability. At USA Bachem, we utilize an advanced oral solid dose delivery system to create drug peptides that are bioequivalent to injectables. This approach saves pain at injection sites and minimizes other bodily reactions to needles—our enabling technologies, including micronization, address solubility-induced absorption issues.
For peptides that exhibit limited bioavailability due to poor permeability through the intestinal barrier, lipid-based or permeation enhancer-based formulation technologies are utilized. To address these challenges, we employ innovative formulation approaches to develop prototypes for oral peptide delivery employing SNAC molecular entities.
Sterile CagriSema manufacturing requires dedicated and specialized capabilities that are compliant with FDA aseptic guidance and EMA regulatory requirements. With our extensive experience in manufacturing parenteral sterile solutions and liquids, we offer a wide variety of delivery systems, including vials, Pre-Filled Syringes (PFS), and ampules. Our state-of-the-art injectable facility and equipment design, combined with highly skilled and trained personnel, are pivotal for the success of your sterile CagriSema manufacturing.
In addition to specialized technologies for the aseptic fill and finish of complex modalities, USA-Bachem Pharma also offers a wide range of terminal sterilization capabilities. Both areas have proven expertise in delivering pre-clinical development and services from clinical through to commercial supply.
SNAC is a synthetic N-acylated amino acid derivative of salicylic acid, used as an intestinal permeation enhancer. SNAC adheres to the gastric mucosa along with peptides to facilitate permeation and absorption. Oral semaglutide (Rybelsus®), the first oral peptide drug, was approved by the FDA and EMA in September 2019 and March 2020, respectively, bringing SNAC into the global public eye. Lozenges and sublingual drug delivery have proven to have similar bioavailability as injectable dosages for candidates who cannot swallow solid pills. Selecting the proper CGMP contract Manufacturer to produce your oral solid peptide dosage form is an important decision. USA Bachem Pharma is your partner of choice for Peptide Oral Solid Dose (OSD) formulation development and manufacturing. We create healthy options for you to choose.
We accompany you throughout the entire lifecycle of your products, from early-phase development and clinical supplies to late-stage registration and validation, as well as commercial manufacturing and packaging. Additionally, we handle APIs down to the picogram-per-cubic-meter level.
USA Bachem Pharma has five state-of-the-art facilities focused on the development and manufacturing of CagriSema OSD formulations and peptides, as well as other New Chemical Drug Entities. From small-scale development and early clinical phase quantities to commercialization, our capabilities include a wide range of services such as formulation development, finished dose manufacturing, and packaging that support new chemical entities, reformulations, and generics
Our Conventional processing technologies are:
Solutions for APIs with bioavailability challenges are:
Oral Peptides Base Formulation consists of:
USA Bachem Pharma develops and manufactures products ranging from small quantities to commercial-scale quantities. Our expertise in oral solid dose manufacturing of peptide drug products, along with a long-standing reputation for quality and reliability in all regulated markets, including Japan, makes us your OSD partner of choice.
Our scientists have mastered the core principles of synthesizing advanced Peptide APIs and apply them to every project, whether large or small. Our Peptides platform offers specialized, combined expertise across multiple cGMP facilities, spanning from early-stage to commercial supply of advanced Peptide APIs.
Proprietary process technologies offer access to a wide range of products for cost-effective manufacturing, featuring robust CMC dossiers that reduce the number of chemical steps required, thereby increasing purity and decreasing raw material costs. An additional benefit includes our unique backward integration of key starting materials, which secures your supply chain in terms of price & quality.
Furthermore, your benefit extends to the seamless transfer of your project within our facility network, enabling the production of drug products and packaging services. The Injectables Platform offers aseptic and terminal sterilization fill and finish services in Pre-Filled Syringes (PFS), ampules, liquid & lyophilized vials, as well as combination device products, packaging/labelling, and clinical trial kit management.
Our three Texas facilities and two California locations are dedicated to the development and production of peptide oral solid dosage forms and possess expertise in conventional processing technologies, including wet and dry granulation, as well as fluid bed techniques. We specialize in peptide tablets (including standard and minitablets) and capsules (comprising direct API, powders, pellets, and minitablets), with options for both aesthetic and enteric coating.
We also supply Dulaglutide, Liraglutide, and Exenatide in both oral solid, liquid, and lyophilized sterile dosage forms. Our highly potent solid phase peptide synthesis
platform offers oral & sterile, highly potent drug products, including packaging, labeling, and distribution. Other custom peptides are synthesized upon request.
Copyright © 2025 Peptidences - All Rights Reserved.
FDA Registered API Peptides
We use cookies to analyze website traffic and optimize your website experience. By accepting our use of cookies, your data will be aggregated with all other user data.