Biopharma
Microgravity enables differentiated drug products
Processing in a microgravity environment dramatically alters buoyancy, natural convection, sedimentation, and phase separation—driving significant differences in transport-driven phenomena.
Why Microgravity?
A gravity-off switch for material processing
Processing materials in microgravity (µg), or the near-weightless conditions found in space, offers a unique environment not available through terrestrial processing. These benefits primarily stem from the lack of convection and sedimentation.
These effects are “locked” into the material, typically through material crystallization, before being brought back to Earth.
Flame in 1g environment versus in µg environment on the International Space Station
The impact of gravity
While gravitational forces do not directly impact thermodynamic properties of systems, they do significantly impact kinetic and hydrodynamic processes. Microgravity suppresses convection and sedimentation, resulting in more uniform supersaturation, as well as diffusion-driven transport. The resulting environment enables crystallization outcomes that lead to improvements in bioavailability, enhanced physicochemical properties, differentiated intellectual property, and new routes of administration — all realized by conducting research in microgravity.
Formulation
Varda’s microgravity platform provides a unique path to
formulating small molecules and biologics to improve
shelf-life, bioavailability, and patient compliance.
Crystallization
Reduced convection and sedimentation allows for solid state tuning and can result in the formation of large and ordered crystals for high-resolution X-ray structural determination or small and uniform particles to improve drug delivery.
Intellectual property
The unique environment of microgravity allows for the
generation of enabling product and process IP for new
chemical entities (NCEs) as well as life cycle management of
marketed drugs.
Screening
Varda's extensive terrestrial crystallization lab includes a pharmaceutical hypergravity facility designed to accelerate development programs, building gravity-dependencies directly into drug substance development right here on Earth.
Working with Varda
Gravity-enabled pharmaceutical development funnel
Initial characterization & process design
Varda conducts process characterization on custom and traditional crystallization hardware for small-volume screening (Crystal16, Technobis) as well as larger-scale automated reactors (EasyMax, Mettler Toledo) with complimentary process analytical technologies. Varda offers:
- Traditional solid state (XRPD, DSC, and TGA) and particle characterization (laser diffraction, dynamic image analysis).
- Crystallization process development, coupled with in-situ sensors (video microscopy, Raman, infrared) to probe and assess crystallization kinetics in real time to map process windows and ensure robust experimental design.
Hypergravity testing to discover commercial opportunities for microgravity production
At Varda, we couple our spacecraft, process equipment, and manufacturing capabilities with terrestrial hypergravity testing to unlock commercial opportunities for in-space production.
Crystallization experiments are conducted with custom or commercial off-the-shelf hardware compatible with Varda’s hypergravity platform to assess drug properties and performance across a range of gravity levels. Varda’s hypergravity platform allows us to:
- Perform drug development unit operations under hypergravity.
- Observe and quantify gravity-dependent drug product performance metrics as a function of gravity (size vs. gravity, polymorph ratio vs. gravity, and more).
- Develop process models which incorporate gravity as a variable to enable predicting or anticipating the impact of microgravity on drug properties or performance.
Autonomous in-orbit process development with material return to Earth
Varda’s capsule allows process development in orbit with return of materials to Earth. To conduct testing in orbit, Varda handles each step for our customers:
- Small molecule and biologic process development and manufacturing capabilities
- Sample handling, preparation and loading for in-flight studies
- Full mission operations and experimental controls from Los Angeles, CA ground based facilities
- On Earth, sample recovery, handling and analysis
Comprehensive analysis of microgravity-produced materials
Once our customers’ sample returns to Earth, they can fully characterize all materials produced and recovered from microgravity studies with Varda or through external strategic partners.
Varda and its partners are equipped with a full suite of analytical testing capabilities:
- Diffraction: SCXRD, XRPD, T-XRPD and Synchrotron
- Thermochemistry: DCS, mDSC and TGA
- Spectroscopy: FTIR, NMR, Raman, UV-VIS
- Microscopy: SEM and TEM
- Others: Dissolution, DVS, HPLC, KF, LOD and PSD
Hypergravity Testing
Use hypergravity to rapidly assess gravity’s impact to your therapeutic program
Varda has developed hypergravity screening methodologies that can, in a cost-effective way, measure the role of gravity in affecting drug product performance. Varda’s platform allows us to rapidly screen a broad set of potential drug candidates for space, inclusive of both small molecule and biologic modalities. Initial screening allows Varda to fly therapies that point toward the most promising microgravity candidates.
Using gravity sensitivity trends to open up new process windows
Varda’s hypergravity crystallization platform demonstrated the effect of gravity on nucleation and growth kinetics for a seeded cooling crystallization of L-histidine. The studies illustrate the ability to use gravity as a variable to influence particle size distributions of small molecule therapeutics.
Please contact pharma@varda.com for microgravity crystallization information.
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