Achieve Critical Milestones in Your Drug Development Program

At Altasciences, we specialize in diverse immunomodulators, including proteins, oligonucleotides, biologics, bispecific antibodies, and gene therapy.

Our evaluations count on essential biomarkers, like cytokines, complement factors, immune cell subtyping, and functional measurements.

Rely on us for:

• precise drug quantitation and biomarker assessment;
• state-of-the-art bioanalytical platforms to monitor multiple aspects of immunomodulation in various species;
• bioanalytical teams with relevant experience handling pathogens and working with infectious samples for your vaccine development programs; and
• labs equipped with containment Level 2 (CL2) areas for handling pathogens within the Risk Group 2.

VIEW FACT SHEET

Need more guidance? Send us a message.

You may also be interested in the below resources:
Fact Sheet: Immunogenicity Testing
eBook: Key Biomarkers of Immunomodulation
Webpage: Bioanalytical Platforms

Altasciences' dedicated pharmacists bring a wealth of expertise in controlled substances and complex compounding, ensuring maximum precision and safety standards.

What you can expect:

Cutting-Edge Facilities

- USP 797 certified clean rooms with Class II biological safety cabinets.
- Negative pressure, HEPA-filtered extemporaneous compounding rooms equipped with the advanced PowderSafe™ ductless balance enclosure, guaranteeing sterile and controlled environments for multiple dosage forms.
- Electronic security access to the pharmacy and video monitoring.
- 24/7 monitoring of temperature and humidity.

Regulatory Excellence
- Licenses for Schedule I through IV drug substances.
- Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our      three clinical pharmacology units.
- Exceptional inspection results from major regulators such as the FDA, HC, EMA, and MHRA.

Comprehensive Capabilities 
- Extensive experience in extemporaneous and intravenous preparation, including biologics.
- Fully equipped to support all types of IP administration forms.

Clinical Supply Manufacturing
Integration with our manufacturing team, ensuring flexibility and adaptability to meet the evolving needs of your studies throughout your drug development program or study.

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You may also be interested in the following webpages:​​​

Clinical Research Services

Pharmaceutical CDMO and Contract Manufacturing Services

DID YOU KNOW?
Our CDMO team offers formulation development and manufacturing of your API, from discovery through commercialization. We also provide analytical testing, ICH stability storage and testing, as well as finished product and release testing. We can manufacture almost every dosage form on the market.

The choice of dosage form in drug development depends on various factors, such as the properties of the API, the therapeutic goals, and regulatory considerations. Taking those factors into account, liquid-filled, hard-shell capsules (LFHCs) offer several advantages compared to other traditional solid oral dosage forms, such as:

•    improved solubility and bioavailability
•    enhanced stability
•    customizable release profiles
•    flexibility of formulation
•    faster onset of action
•    potential for combination therapies
•    improved patient compliance in clinical trials

To learn more about the application of LFHCs in drug development, and how they can accelerate your timeline, consult the resources below.

eBook: The Applications of Liquid-Filled Capsules in Pharmaceutical Development
Interview: Benefits of Using Liquid-Filled Capsules in Clinical Trials
Case Study: Rapid Development of a Liquid-filled, Hard-Shell Capsule Formulation of Cannabidiol

To find out if your compound is suitable for LFHCs, speak with one of our experts today.