Pharmaceutical Testing Services for Rapid Formulation Decisions
Integral BioSystems provides pharmaceutical testing services for biotech and pharmaceutical companies that need deformulation, dissolution, or permeability data without committing to a full contract research organization engagement. The service runs on the same cGLP-compliant instrumentation used across Integral’s formulation programs, applied to a defined test or panel with a stated turnaround time. Shikha Barman, PhD, Founder and CEO, describes the approach directly, “No job is too small or too large for Integral BioSystems to give its undivided attention.”
Deformulation of Approved Drug Products for Generic Development
Deformulation testing reverse engineers an approved reference product to support generic drug development. Integral BioSystems applies its formulation and analytical instrumentation to characterize the reference product’s physical, chemical, and release properties, generating the data a generic development program needs before formulation work begins. The characterization methods used in deformulation work are the same core techniques described on Integral’s analytical method development services page, applied here to an approved product rather than a new candidate.
Deformulation analysis typically draws on:
- Chromatographic assay and impurity testing (HPLC/UPLC)
- Thermal characterization (DSC/TGA)
- Particle size analysis
- XRPD for solid-state form
Dissolution and In-Vitro Drug Release Testing
Integral BioSystems runs dissolution and in-vitro release testing (IVRT) using USP Apparatus I, II, and IV dissolution methods and a Float-a-lyzer set-up, the same instrumentation listed on the facility’s equipment inventory. The USP Apparatus IV flow-through cell is recognized by the FDA and USP General Chapter 1724 for in-vitro release testing of ophthalmic and topical systems.
Dosage forms tested:
- Tablets
- Microspheres (in-vitro drug release)
- Nano-sized drug suspensions
- Micronized drug suspensions
- Creams
- Ointments
Expanded Permeability Testing Beyond Corneal Tissue
Pharmaceutical testing services extend the corneal Franz cell permeability work already described on Integral’s analytical method development services page to scleral, dermal, and intestinal permeability, supporting ocular, dermal, and oral formulation programs that need tissue-specific permeation data. For programs evaluating ocular delivery specifically, the expanded corneal and scleral data complements Integral’s ophthalmic formulation development services.
Turnaround Tiers for Rapid Testing Decisions
Standard turnaround for pharmaceutical testing services is seven business days. Expedited turnaround is available for select tests, confirmed at the time of quote. The tiered structure is built for formulation and regulatory teams working against a defined decision point, such as a go or no-go call on a candidate, rather than a full development timeline.
Turnaround tiers:
- Standard, seven business days
- Expedited, three to five business days, select tests
- Rapid expedited, one to two business days, select tests
Why Formulation Teams and Emerging Companies Choose Integral BioSystems for Testing
Pharmaceutical testing services can be ordered as a standalone engagement, without committing to Integral BioSystems’ full drug development services. Testing runs on the same instrumentation described on Integral’s CRO facilities and capabilities page, giving smaller biotech teams and early-stage companies access to the same equipment used across Integral’s ophthalmic and injectable formulation programs. Since 2009, Integral BioSystems has supported biotech, mid-size pharma, and emerging companies advancing molecules from preclinical formulation toward clinic-ready products.
Consider standalone testing services when:
- Dissolution or release of data is needed before a formulation decision
- Deformulation data is needed to support a generic development timeline
- Permeability data is needed for a tissue not yet characterized on a specific candidate
- A full development engagement has not started yet
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Pharmaceutical Testing Services FAQs
What Is Included in Pharmaceutical Testing Services?
Pharmaceutical testing services at Integral BioSystems cover deformulation of approved drug products for generic development, dissolution and in-vitro release testing, and permeability testing across corneal, scleral, dermal, and intestinal tissue. Each test or panel can be ordered on its own, with a stated turnaround time.
Do I Need a Full CRO Engagement to Order Testing Services?
No. Testing services can be ordered as a standalone engagement against a defined test or panel. Programs that later need formulation development, method validation, or scale-up support can move into a full development engagement at that stage.
What Turnaround Times Are Available for Rapid Testing?
Turnaround tiers run from seven business days down to one to two days on select tests. Eligibility for expedited turnaround depends on the specific method and current lab schedule, confirmed at the time of quote.
Which Dosage Forms Can Be Tested for Deformulation of Generic Drug Products?
Deformulation testing for generic drug development covers ophthalmic, injectable, dermal, rectal, and pulmonary drug products.
Does Permeability Testing Cover More Than Corneal Tissue?
Yes. In addition to the corneal permeability testing described on Integral’s analytical method development services page, pharmaceutical testing services add scleral, dermal, and intestinal permeability panels.
Discuss Your Pharmaceutical Testing Needs
Integral BioSystems has applied its formulation and analytical instrumentation to biotech and pharmaceutical drug development programs since 2009. Contact Integral BioSystems to scope pharmaceutical testing services for your program, whether that is a single test or a full deformulation, dissolution, or permeability panel.