Formulation Development FAQs
What formulation types does Exemplify specialize in?
We develop solid oral, liquid, and semi-solid formulations including immediate-release, modified-release, sprinkle, and topical dosage forms. Our capabilities span pre-formulation through clinical-phase manufacturing, emphasizing reproducible performance and stability.
Do you develop both solid and liquid dosage forms?
Yes. Exemplify supports solid oral forms such as tablets and capsules, as well as solutions and suspensions for early clinical programs. Each dosage form is optimized for the compound’s solubility and bioavailability characteristics.
Can you support formulation development for early toxicology studies?
Absolutely. We design fit-for-purpose non-GMP formulations that achieve target exposure in preclinical models. Prototype formulations are rapidly iterated to generate PK and tox data enabling IND submission.
Does Exemplify support CMC developability assessments?
Yes. We complete a comprehensive assessment that includes physiochemical characterization, solid state properties, solubility, stability, pKa measurement, and evaluation of the synthetic route.
How do you approach pre-formulation and solid-state characterization?
Our pre-formulation studies assess API polymorphism, solubility, hygroscopicity, and excipient compatibility. Using XRPD, DSC, and TGA, we define the optimal solid form and guide formulation selection and stability risk mitigation.
What equipment do you use for capsule filling and micro-dosing?
We utilize the Xcelodose X600S (Lonza) precision powder micro-dosing system, capable of filling neat API down to 0.1 mg per capsule with ±2 % accuracy. This enables early human exposure studies without excipient dilution.
Can you perform bi-layer tablet compression?
Yes. Our Kambert Expert 2 bi-layer tablet press supports 16 stations (8D + 8B) for immediate/modified-release combinations or fixed-dose products, under full GMP documentation.
What granulation technologies are available at Exemplify BioPharma?
We employ top-spray and Wurster fluid-bed granulation (ACG Quest FB II), high-shear granulation (ACG HSM II), and roller compaction (Kevin KRC 120×40). Each process is scaled between 500 g and 20 kg per hour.
Do you develop immediate-release, delayed-release, and extended-release formulations?
Yes. Exemplify designs IR, DR (enteric), and ER formulations using polymeric coating, matrix systems, and osmotic or pulsatile technologies. Selection depends on drug solubility, permeability, and target pharmacokinetics.
Do you develop and qualify dissolution methods?
Absolutely. We develop dissolution methods which are discriminative.
How do you evaluate dissolution profiles during formulation optimization?
We use USP Apparatus 1/2 and multi-media dissolution testing to assess release kinetics under physiologically relevant pH conditions. Profiles are correlated with in-vitro/in-vivo relationships to guide formulation refinement.
Can Exemplify transfer clinical formulations to commercial manufacturing sites?
Yes. Tech-transfer packages include master batch records, validated analytical methods, critical process parameters, and full documentation for client or partner CDMO implementation.
Do you offer DOE-based formulation optimization?
We employ statistical Design-of-Experiments to identify key variables affecting dissolution, hardness, and stability. DoE outputs establish design space and support QbD-compliant control strategies.
How do you ensure uniformity and reproducibility in small-scale formulations?
Content uniformity is verified through blend sampling and capsule/tablet assay testing. Scale-down equipment mirrors commercial mixing and compaction forces to ensure linear scale-up.
What types of topical formulations can you support?
We formulate creams, gels, and ointments using rheology-controlled bases and evaluate viscosity, spreadability, and drug release via Franz diffusion cells. Stability studies follow ICH Q1A protocols.
Can you perform scale-up for Phase 1, Phase 2, and Phase 3 clinical manufacturing?
Yes. Exemplify produces GMP clinical batches for Phase 1–3 studies using qualified blending, granulation, and coating equipment. Batch sizes range from pilot to multi-kilogram scale under full QA oversight.
Do you perform ICH stability testing for formulated products?
We conduct full ICH Q1A-F stability programs on finished dosage forms, including accelerated and long-term studies at multiple humidity/temperature conditions, with periodic testing and data trending.
What types of packaging and sealing equipment do you have on site?
Our facility includes a semi-automatic tube filler, induction sealer for HDPE bottles, and blister and pouch sealing options suitable for clinical packaging. Packaging validation and container-closure integrity testing are performed per protocol.
How do you address formulation challenges for low-solubility APIs?
We apply solid-dispersion, salt, or particle-size engineering approaches, leveraging wet milling and spray drying where appropriate. Solubility enhancement strategies are evaluated through dissolution and permeability assays.
Can you help troubleshoot failed validation or bioequivalence studies?
Yes. Our scientists perform root-cause analysis using comparative dissolution, blend uniformity, and solid-state characterization data to pinpoint failure modes and propose reformulation or process modifications.
What is the capacity of your fluid-bed processor and tablet-coating systems?
The ACG Quest FB II handles 3 L, 9 L, and 12 L bowl sizes for top-spray granulation and Wurster coating. The ACG Quest TC II tablet coater supports 3–12 L batches with uniform film deposition monitoring.
Do you perform process validation and report generation for formulation batches?
Yes. We execute stage-appropriate process validation including blending, compression, and coating validation runs. Protocols, analytical results, and statistical evaluations are compiled into formal validation reports reviewed by QA.