5 benefits for biologics

Ambient, high-yield, thermostable - explore the benefits

LaminarPace utilizes laminar flow thermodynamics and mass transfer to dry delicate biologics at room temperature. It is highly relevant for vaccines with demanding formulations (such as LNPs), RNA therapeutics and next-generation personalized vaccines and treatments. LaminarPace has worked successfully with a variety of excipients, adjuvants and antigens. 

LaminarPace delivers 5 key benefits when formulating biologics.

Thermostability - your way

At Ziccum we understand that different organizations have different thermostability needs and define thermostability differently. Our team has extensive experience working with a wide range of regulatory definitions of thermostability including ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) and WHO guidelines. LaminarPace ambient drying offers advanced thermostability outcomes.

Versatility in thermostability

Our ambient methodology, combined with our experience across a wide range of vaccine platforms, enables us to offer clients innovative, effective thermostability solutions that are right for their products, whatever their thermostability needs.

“Vaccine thermostability depends on multiple elements – platform type, antigen type, presence of adjuvants, choice of excipients, desired administration route.

“Our experience in these areas, combined with our ambient technology, can expand a company’s understanding of how thermostability can be achieved for them– and the opportunities it delivers.”

- Fabrice Rose, Scientific Director Ziccum

High yield - lower costs

The cost of pharmaceutical raw materials is high – and increasing. Optimizing process yield and reducing waste is a key priority in today's competitive, post-pandemic  business climate. Ambient drying delivers a higher process yield and lower substance cost to pharmaceutical manufacturers.

80% process yield

A typical process yield in spray drying is around 40 – 70%. Ambient drying delivers a comparatively high process yield of around 80%. This is due both to LaminarPace’s inbuilt laminar flow, and Ziccum’s continuous Quality by Design optimization of key features.

But it doesn’t end there. Ziccum is engaged in carrying out advanced 3D digital flow modeling as part of the system’s ongoing technological development. 3D modelling will enable more detailed models of process yields and volumes, and how they can be optimized and tailored. LaminarPace’s high process yield and digital modeling capabilities offer competitive operating costs to developers and manufacturers in comparison with legacy drying systems.

Novel administration routes - moving beyond injectables

LaminarPace enables the formulation of biologics for a wide range of novel administration routes beyond injection, expanding the possibilities for biologic APIs.. It delivers greater control over key properties of the dried particles, for example particle size, which is crucial for creating an inhalable material.

LaminarPace powder formulations are fast-dissolving and enable application possibilities from inhalable drugs to microarray patches to topical application of particles through the skin to reconstituted intravenously administered drugs.

Our particle engineering pedigree

LaminarPace was originally invented by Assoc. Prof of Inhalation Toxicology Per Gerde at the Institute of Environmental Medicine in Karolinska Institutet. He developed LaminarPace specifically to generate small amounts of micronized particle material for aerosolization, originally micronizing particles down to 1 – 5 microns. Consequently, the system delivers dried particles that are well dispersed, with excellent size distribution, producing fast-dissolving powders that are well-suited to inhaled and novel administration routes.

Aseptic drying

By 2027 sales of biologics therapies are forecast to overtake sales of small molecules by 120 billion USD, accounting for 55% of all innovative drug sales. Yet maintaining sterility remains a challenge. Biologics are parenteral therapies with higher risk of infections, and stringent demands on aseptic administration. Furthermore, biologics remain fragile, delicate substances that can rarely withstand exposure to the kinds of high temperatures required for sterilization. LaminarPace offers a solution.

Driving industrial integration

For Ziccum, aseptic development is a key element supporting the acceleration of LaminarPace’s industrial development. We are developing LaminarPace as a unit of production that can be readily installed and integrated into the pharmaceutical manufacturing process. LaminarPace is already being optimized with a range of biosafety features including its sealed glove box and powder collector, as well as new processes for cleaning and sterilizing the system. Developing the system as an aseptic, one-step process is a key enabler of industrial integration.

One-step process: reducing risk in biopharma production

LaminarPace is a one-step process. It avoids the complex, multi-step stages of lyophilization (freeze drying) for example. Its ambient, one-step methodology enables it to reduce the risk of particle stress or degradation from dehydration and extreme temperatures. It delivers excellent aerosolization and particle engineering capabilities.

3D digital modelling and optimization

The system has undergone continuous technological development throughout Ziccum’s lifetime and has been optimized and evolved towards industrial scale-out through continued use in a wide range of development projects. LaminarPace is being designed so that it can be directly installed into the pharmaceutical manufacturing process in industrial collaborations. The advanced 3D digital modeling Ziccum is carrying out on LaminarPace will enable the most competitive efficiencies of scale and production to be calculated for clients according to exact substance and volume requirements.

LaminarPace’s one-step methodology, its advanced stage of industrial development and its digital modeling capabilities all offer competitive operating costs to developers and manufacturers in comparison with legacy drying systems.