Bachem offers complimentary white papers on innovative products, services or processes in peptide NCEs and oligonucleotide NCEs research, as well as technical information on custom peptide synthesis.
Enzymatic Ligation and Other Innovative Technologies: Shaping the Future of Large-Scale Oligonucleotide Manufacturing
This whitepaper explores how Fragment synthesis and enzymatic ligation improve yield, scalability, and sustainability over traditional methods.
Conjugation Chemistry: Improving Oligonucleotide Targeted Delivery
This whitepaper explores oligonucleotide therapeutics, focusing on their challenges such as stability, targeting, and uptake, and how peptide conjugation can overcome them. It covers key oligonucleotide types, conjugation strategies, chemistries, and examples of successful conjugates.
Risk Management in Clinical Trials for API Manufacturing
Bringing a peptide therapy to market requires more than innovation—it takes a strong CMC strategy to manage risk, scale production, and meet regulatory standards. This case study highlights how Bachem supported a biotech partner on two peptide projects: one optimizing API production for scalability and compliance, the other addressing complex manufacturing challenges through early risk assessment using FMEA.
MOLECULAR HIVING™ FOR SUSTAINABLE PEPTIDE SYNTHESIS
Innovative, cost-efficient, and environmentally friendly technologies are critical. Traditional solid-phase peptide synthesis (SPPS) poses environmental and scalability challenges. Our white paper explores Molecular Hiving™ (MH), a groundbreaking technology combining liquid-phase peptide synthesis (LPPS) with efficient, aqueous-based purification. MH offers a sustainable, streamlined alternative to SPPS, aligning with our commitment to green chemistry and sustainable manufacturing practices.
PIONEERING SUSTAINABLE, LARGE-SCALE TIDES MANUFACTURING
In a changing world, where global warming and limited resources are a priority, our vision and the way we do business must evolve. Sustainability has become a top priority in the pharmaceutical manufacturing sector. Bachem’s white paper explores how the company is pioneering sustainable practices in the production of therapeutic peptides and oligonucleotides (TIDES), ensuring minimal environmental impact while maintaining high standards of quality.
MAINTAINING A RESILIENT TIDES SUPPLY CHAIN UNDER VUCA CONDITIONS
In today’s unpredictable world, ensuring a resilient pharmaceutical supply chain is more critical than ever. Bachem’s white paper, “Maintaining a Resilient TIDES Supply Chain Under VUCA Conditions,” explores the innovative strategies and technologies that enable consistent API production despite global disruptions. Discover how Bachem navigates these challenges to deliver high-quality medications consistently, safeguarding patient health worldwide.
IMPROVING OLIGO MANUFACTURE WITH STIRRED-BED
Oligonucleotide-based active pharmaceutical ingredients (APIs) have emerged as a powerful approach to treating diseases. With hundreds of them in advanced clinical trials, a potential metric ton demand for certain products is expected that might not be easily fulfilled by conventional solid phase oligonucleotide synthesis (SPOS). It is essential to develop more efficient, more sustainable, and highly scalable manufacturing techniques.
This whitepaper explains how the innovative stirred-bed technology (SBT) for SPOS fulfills all these requirements and represents an economical engineering solution with a simple reactor design and adapted chemistry. Thus, ton-scale commercial oligonucleotide API manufacture with unmatched process mass intensity is within reach.
Bachem develops a cost-effective, large-batch process for octreotide acetate synthesis
Octreotide acetate is a therapeutic octapeptide analog of the naturally occurring hormone somatostatin. This longer-acting synthetic peptide agonist is used for the reduction of growth hormone and insulin-like growth factor 1 primarily used in adults with acromegaly.
New therapies such as oral formulations promise better disease control and quality of life for patients but require 30-60 times higher octreotide acetate concentrations, thus putting demand on complex API manufacturers such as Bachem to cost-effectively scale production.
Our client, a large pharmaceutical company who once manufactured octreotide in-house, decided in 2016 to partner with Bachem to take over large-scale API production. A win-win collaboration.
Greener purification at large-scale
An oligonucleotide case study
Resembling a new era of innovative drug development, the interest of the biopharma industry in the oligonucleotide markets has grown significantly in the past five years.
In 2021, the US Food and Drug Administration (FDA) approved the first-in-class siRNA to lower cholesterol – a drug with a multi-ton potential to treat millions of patients per year. Moving forward, the demand for oligonucleotide batch size is likely to increase as well as the need for large-scale manufacturing capacity to support this growth.
Reducing Solvent Consumption for Large-scale Peptide API Manufacturing
A peptide case study
Resembling a new era of innovative drug development, the interest of the biopharma industry in the peptide and oligonucleotide markets has risen significantly in the past five years. The advent of oral and inhaled peptide products has driven demand for these active pharmaceutical ingredients (APIs).
Between 2018 and 2020, the average peptide manufacturing batch size increased by 2.3 times in response to a wider variety of peptide drug modalities entering the market. Furthermore, with the launch of new glucagon-like peptide (GLP) analogs targeting metabolic diseases like diabetes and obesity, there is a growing need for large-scale manufacturing of these APIs to treat a large patient population.
Continuous Chromatography – Pushing the boundaries of peptide and oligonucleotide production
In peptide API manufacturing robust purification processes are essential for attaining high purity and yield. These processes are also critical determinants of cost efficiency and overall process productivity.
Multicolumn Countercurrent Solvent Gradient Purification (MCSGP) has shown to achieve substantially higher capacity and yield than single-column batch processes. This innovative purification process leads to time savings, economic advantages and a lower environmental footprint.
A New Turn in Peptide Purification
Innovation is a central pillar of Bachem’s success. Our dedicated teams explore and develop new technologies to bring innovative solutions to our partner’s needs. Here, we will introduce a new innovation that represents a new turn in peptide purification.
Read the full white paper on a new turn in peptide purification.
Microspheres and Nanoparticles for Peptide Delivery
Proteins and peptides fulfill an irreplaceable role as medicines due to their high affinity, specificity, low toxicity, and ability to alter protein-protein interactions. They are widely recognized as therapeutic agents in the treatment of a variety of conditions, including diabetes, osteoporosis, nonHodgkin’s lymphoma, and leukemia. Clinical development is on-going as the pharmaceutical industry works to harness the potential of peptides for many other conditions. While incredible progress has been made in designing peptide- and protein-based drugs for multiple therapeutic uses, challenges remain. This white paper explores challenges of peptide- and protein-based new chemical entities [NCEs]including potential chemical and physical instabilities, enzymatic degradation, and their rapid elimination from circulation.
Read the full white paper on microspheres nanoparticle.
