ISSUE NO. 46 – SPRAY DRIED DISPERSIONS
Spray-dried dispersions (SDDs) are an effective method to improve solubility and bioavailability of your active pharmaceutical ingredient (API) in early-phase drug development. The spray drying process involves converting a liquid into a dry powder, with the resulting SDDs benefiting from improved characteristics for further developments. Spray drying can also be combined with nanomilling for further improve the bioavailability and for flexible downstream processing.
In Issue 46 of The Altascientist, explore:
- how SDDs improve efficiency of early-phase drug development
- applications and benefits of spray drying in early-phase drug manufacturing
- advances in spray drying technology for pharmaceutical development
- the use of spray dry technology in early-phase development of proteins and peptides
- key considerations for the development of spray-dry pharmaceuticals
Clinical Trials Without Boundaries: Multi-Site Solutions at Altasciences
Streamlining Cross-Service Line Offerings for Accelerated Drug Development
Biomedicines: In Vivo Characterization of ONL1204, a Small Peptide Inhibitor of the Fas Receptor, as a Potential Neuroprotective Therapy for Geographic Atrophy and Dry Age-Related Macular Degeneration
Altasciences and Evidence Matters Announce Strategic Collaboration to Advance AI-Enhanced Text Engineering for Regulatory Writing in Life Sciences
Laval, Québec, August 27, 2025 — Altasciences, a fully integrated CRO/CDMO offering comprehensive early-phase drug development solutions, is pleased to announce a strategic collaboration with Evidence Matters, a pioneer in clinical trial data science and document engineering.
This partnership combines Altasciences' real-world drug development expertise with Evidence Matters' innovative, patent-pending Text Engineering technology—a breakthrough that delivers near-deterministic accuracy in regulatory writing by reducing variability and improving the quality, consistency, and speed of documentation.
Evidence Matters' RegulatoryFlow platform (“RegFlow”) and specialized services unify clinical data and documents, simplify workflows, and accelerate the work of key life sciences professionals, from medical writers to regulatory specialists.
“We are excited to work alongside Evidence Matters to co-develop technology that directly enhances the quality and efficiency of regulatory writing,” said Nicole Maciolek, Vice President, Research Services at Altasciences. “Through this partnership, we’re not just implementing AI, we’re actively shaping its future as an indispensable tool in life sciences.”
Altasciences is deeply engaged in the partnership, contributing real-world training data and conducting user testing to help ensure the technology meets the needs of frontline teams. This collaboration underscores Altasciences' ongoing commitment to leveraging artificial intelligence to drive innovation, streamline complex processes, and deliver better outcomes for both sponsors and patients.
"With Text Engineering, we're moving beyond automation into a new era of precision and consistency," said Dr. Ofer Avital, Founder and Director of Evidence Matters. "The impact on regulatory documentation, from timelines to accuracy, is transformative. In testing against manual work, RegulatoryFlow demonstrated the elimination of table transfer errors that can touch approximately one-third of tables in life science regulatory documents, while reducing TFL-to-Word processing time by more than 50%.”
Dr. Avital also added, “Unlike traditional enterprise platforms that require extensive implementation timelines, RegulatoryFlow integrates seamlessly with existing Microsoft Word workflows, enabling rapid deployment in weeks rather than months, and meets medical writers right where they work."
Together, Altasciences and Evidence Matters are redefining what's possible in clinical trial implementation and documentation, helping sponsors move faster, and with greater confidence, from candidate selection to clinical proof of concept, and beyond.
About Altasciences
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 30 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, research support, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster. To learn more, visit altasciences.com.
Julie-Ann Cabana
Altasciences
media@altasciences.com
A Professional Perspective on the FDA Roadmap Announcement on “Phasing Out” Animal Testing Requirements
The FDA’s Roadmap to Reducing Animal Testing in Preclinical Safety Studies announcement in April 2025 for “phasing out” animal testing requirements has been in process for several years.
Altasciences Chosen by Steel Therapeutics to Support the Launch of Pivotal Toxicology Study for Fizurex™
Laval, Québec, August 21, 2025— Altasciences is pleased to have been chosen by Steel Therapeutics, Inc. (“Steel”), to initiate a pivotal toxicology study for Fizurex™, a novel topical therapy for the treatment of anal fissures.
The GLP-compliant study is currently being conducted at Altasciences’ preclinical facility. It marks a key milestone in Steel’s regulatory development, as the company prepares for an Investigational New Drug (IND) application in early 2026.
“We’re proud to be supporting Steel Therapeutics at this key stage of their development journey,” said Steve Mason, Co-COO at Altasciences. “Our teams are aligned in their commitment to accelerate the delivery of patient-centered therapies. The initiation of this study is another example of how early collaboration and scientific rigor can bring important treatments closer to market.”
Fizurex™, a patent-pending compounded wipe, has seen widespread use in clinical practice and is now progressing through the formal regulatory pathway to reach broader patient populations under FDA oversight. Steel engaged Altasciences due to their deep expertise in preclinical safety evaluation and proven ability to execute with speed and precision.
“Working with Altasciences allows us to maintain the highest standards of quality as we move Fizurex™ into its next phase of development,” said Matt Stahl, CEO and Founder of Steel Therapeutics. “This study represents a major step forward for our company and for the patients who stand to benefit from more consistent, scalable access to this treatment.”
Altasciences’ integrated, collaborative approach to drug development enables companies like Steel to move efficiently from discovery through to clinical trials, all under one organizational umbrella.
“We look forward to continuing our partnership with Steel Therapeutics as they advance their portfolio of innovative, patient-focused therapies,” added Mason.
About Altasciences
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 30 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, research support, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster. To learn more about Altasciences, visit altasciences.com.
Julie-Ann Cabana
Altasciences
media@altasciences.com
Corridor Business Journal: Steel Therapeutics Launches Toxicology Study for New Fissure Treatment
Altasciences Receives EcoVadis Gold Medal for Environmental, Social, and Governance (ESG) Efforts
Laval, Québec, August 20, 2025 — Altasciences is proud to announce that it has received a sustainability Gold Medal from EcoVadis, placing the contract research organization (CRO) in the 96th percentile and among the top 5% of companies evaluated globally. EcoVadis, the world’s most trusted provider of business sustainability ratings, has collaborated closely with Altasciences to enhance its environmental, social, and governance (ESG) initiatives, underscoring the company’s commitment to a sustainable future and a reduced environmental footprint.
Supported by a powerful technology platform and a team of experts, EcoVadis rated Altasciences on several criteria: Environment, Labor and Human Rights, Ethics, and Sustainable Procurement—all of which achieved scores above 75 out of 100. “We have made great strides in our ESG initiatives, and these scores demonstrate our team's hard work and commitment to ESG principles and a sustainable future,” said David Grégoire, Chief Quality and Compliance Officer, Altasciences.
With responsibility at the heart of its values, Altasciences has integrated ESG principles into every aspect of its operations, championing sustainable practices, ethical governance, inclusion, and employee well-being, and has increased its sustainability rating by 30% from 2024 to 2025.
As a committed participant in the UN Global Compact, the company upholds principles of human rights, labor standards, environmental stewardship and anti-corruption, and is advancing toward science-based emission reductions by 2030, in alignment with the Science Based Targets initiative (SBTi).
Learn more information on Altasciences’ commitment to ESG and sustainability efforts here.
About Altasciences
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 30 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, research support, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster. To learn more about Altasciences, visit altasciences.com.
Julie-Ann Cabana
Altasciences
media@altasciences.com
Microsampling with Impact-Assisted Extraction for Hematocrit-Free Assays