How to bring your LNP formulation to clinical/commercial manufacturing via CDMO

After another year of impressive nominations for the CPHI Pharma Awards our winners were announced at CPHI Barcelona in October 2023. In this series of interviews, we speak to the people and teams behind the award-winning projects, concepts, and technologies. 

Millistak+® HC Pro (high-capacity synthetic media) is a family of synthetic depth filters

The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). 

A single-use sterile sampling assembly that takes representative samples while protecting your bioprocess from cross-contamination. NovaSeptum® SURe sampling as

Several big pharma companies have added their names to a letter challenging suppliers in the healthcare industry to pledge to sustainability targets. 

Merck tests new formulation of effective immunotherapy Keytruda to gain approval in time to extend the patent on the drug before it runs out in 2028. 

A 2 mL Automated Perfusion Cell Culture Platform

Pharmaceutical giant Merck has announced they will be speeding up the processing of a new vaccine against the latest strain of the Ebola virus, to be donated to a global non-profit organisation for distribution

Millistak+® HC Pro (high-capacity synthetic media) is a family of synthetic depth filters providing a cleaner and more consistent depth filtration media over current diatomaceous earth (DE) and cellulose (CE) based filter offerings. Multiple media grades are available for primary and secondary clarification as well as downstream filtration applications.

Natrix® chromatography membrane is a high capacity, high throughput strong anion exchange device designed to purify biomolecules. It combines the capacity of high performing resins with the exceptional flow properties of chromatography membranes. The Natrix® chromatography membrane platform is fully scalable from 0.2 mL devices to production-scale and delivers enhancements in productivity, flexibility, and process robustness for any bioprocess.

Innovative, High-Performance Pod Filters are Ideal for Primary and Secondary Clarification in Lab, Pilot and Process-scale Applications. Millistak+® depth filter media is offered in a scalable, disposable format: the Pod Filter System. 

Accelerate your therapy using our innovative single-use tangential flow filters with superior flux performance. 

A Versatile & Modality-Agnostic Aseptic Autosampling Solution for Reliable On-Line and Near Real-Time Sample Analysis  

An Easy-to-Use GMP Process Analytical Technology (PAT) Platform to Monitor Cell Cultures In-Line and in Real-Time, from Process Development to Manufacturing. 

The next generation of high performance single-use modular bioreactors for fed-batch and perfusion processes. The Mobius® iFlex Bioreactor is a scalable family of single-use bioreactors, ranging from 50 L to 2000 L  and suitable for process development and commercial manufacturing. 

A single-use sterile sampling assembly that takes representative samples while protecting your bioprocess from cross-contamination. NovaSeptum® SURe sampling assemblies can be easily integrated into your single-use manufacturing process. Available in five popular container formats and with two connection options.

An innovative single-use film offering strength and leak resistance for your toughest liquid bioprocessing applications. Ultimus® film provides enhanced bag strength, improved durability and leak resistance through a novel strength layer reinforced by woven nylon. The inert fluid contact layer promotes healthy cell growth and is free of animal-origin components and Irgafos® 168.   

Increase Your Bioreactor Productivity with Our Superior Solution for Upstream Process Intensification. In combination with your bioreactor, the Cellicon® Cell Retention Solution allows you to achieve significantly higher viable cell densities, improving your upstream productivity and manufacturing flexibility. 

A Superior Cell Retention Solution for N-1 Seed Train Intensification with Optimized Process Control. The benchtop Cellicon™ Perfusion Solution is designed to meet your perfused seed train challenges. It consists of a controller and a flat sheet cell retention filter with a single-use assembly running in tangential flow filtration mode. 

A single-use assembly designed to facilitate the freeze and thaw of cryopreserved cells at -80 °C. Mobius® Gold High Cell Density Cryopreservation Assemblies enable seed train inoculation with cells at a higher cell density and larger volume, which significantly accelerates the cell expansion process. The single-use assembly also prevents contamination while improving process reproducibility.

To enable the development of next-generation lipid-based drug delivery systems, expertise and manufacturing capabilities are critical.Relying on more than 20 years experience in GMP lipid/LNP manufacturing, we aim at supporting pioneers in nucleic acid modalities to bring life changing medicines from preclinical to commercial manufacturing.

 Learn more about the opportunities of the mRNA technology and how to overcome drug development and manufacturing challenges to bring your mRNA-based therapies to market in this series of webinars.

Your global partner for the manufacturing of synthetic lipids. Learn more about our offering of portfolio and customized lipids.

Providing high quality raw materials and services for mRNA manufacturing and formulation.

As programs progress through the clinic stage and require scaling to larger-batch sizes, a seasoned commercial partner is critical for program success. Key considerations such as risk mitigation, production scalability, regulatory filing support, and specialized technological capabilities should be thoroughly evaluated. In this webinar, we take a look inside our latest capacity expansion for large-scale GMP API production located in Darmstadt, Germany. With a commitment to phase-appropriate quality, flexibility, and sustainability, the right CDMO partner can help navigate the complexities of large-scale programs.

State-of the-art facility for handling of HPAPIs in the single-digit nanogram OEL range.

Discover our offering of ADC Express™ Services, ADCore advanced payload intermediates and ChetoSensar™ solubility enhancing technology.

We support small molecule API synthesis projects from milligram to commercial quantities. We are the partner to address the most difficult challenges, whether the target is difficult to handle, synthesize, or source.

cGMP quality payload for your drug conjugate programs.

Advanced intermediates

15 years of CDMO expertise in ADC and Bioconjugation with a broad experience in various conjugation technologies.

Enhance dissolution rate and lubrication with a single high performance excipient.

Parteck® PLX provides consistent performance, improved dissolution rate and reliable lubrication – all at the same time.

Development of new active pharmaceutical ingredients (APIs) is lengthy and cost-intensive, thus avoiding any potential risk that may limit the product’s success is of utmost importance. Today, many APIs are not being commercialized as they are poorly water soluble and, as a result, exhibit too low bioavailability.PLX, MXP, SLC, Meglumine

Absorption of molecules from the gastrointestinal tract is an essential consideration when developing orally delivered medications. Solubility, the concentration of drug in solution, is essential for this to occur and it is important to also consider the dissolution rate of the molecule. For DCS Class IIa molecules, defined as having a slow dissolution rate, simple yet effective formulations can be developed. Parteck® PLX 188 excipient should be considered for these challenging molecules to increase dissolution rate, provide hydrophilic lubrication, and enable simple and costeffective manufacturing processes.

Absorption of molecules from the gastrointestinal tract is an essential consideration when developing orally delivered medications. Solubility, the concentration of drug in solution, is essential for this to occur and it is important to also consider the dissolution rate of the molecule. For DCS Class IIa molecules, defined as having a slow dissolution rate, simple yet effective formulations can be developed. Parteck® PLX 188 excipient should be considered for these challenging molecules to increase dissolution rate, provide hydrophilic lubrication, and enable simple and costeffective manufacturing processes.