Process R&D - PharmaBlock USA

Process R&D

You are here: PharmaBlock USA » R&D Services » Process R&D

Process R&D

Synthetic Route Scouting, Development, and Optimization

Innovative Route Design: Our expert team leverages advanced synthetic methodologies to identify efficient, scalable, and cost-effective routes for your active pharmaceutical ingredients (APIs).

Process Optimization: We refine synthetic processes to maximize yield, purity, and reproducibility, ensuring seamless scale-up from lab to production.

Customized Solutions: Tailored development strategies to meet the unique chemical and regulatory requirements of your project.

Data and Mechanism Supported Reaction Optimization

— Optimization work is often performed in Easymax equipment– a superior alternative that provides more accurate, higher-quality data.
— Crystallization process development and form characterization: solubility data through crystal 16
— Impurity formation mechanism, Impurity profiling and characterization, fate and purge study
— Design of Experiments: Perform Design of experiment (DOE) for evaluation the impact of CPPs (critical process parameters) on cQA (critical quality attributes)

Preclinical and GMP Manufacturing for Phase I Clinical Trials

Preclinical Support: Robust preclinical manufacturing to provide high-quality materials for early-stage testing, enabling confident progression to clinical phases.

GMP Manufacturing: Fully compliant with Good Manufacturing Practice (GMP) production, ensuring safety, quality, and regulatory adherence.

Scalable Production: Flexible manufacturing capabilities to support small-scale batches for early trials, with seamless transition to larger-scale production.

Solid State Capability

Polymorph and Salt Screening: Comprehensive solid-state screening and characterization to identify optimal crystal forms, enhancing stability, solubility, and bioavailability.

Advanced Milling Capability: State-of-the-art jet milling technologies to achieve precise particle size distribution, optimizing dissolution rates and bioavailability.

Formulation Support: Expertise in developing solid-state forms to meet your drug product’s performance and regulatory requirements.

Advanced Analytical Techniques: Cutting-edge tools for precise characterization, ensuring consistency and quality in every batch.

Equipment

Synthesis Station

EasyMax x 2
Mya 4 x 2

Reaction Safety

TGA (Seiko)
DSC (TA)
ARSST Fauske

Reaction Scale up

JRLs (1Lx 2L) Buchiglass
Chemglass reactors x14
Buchi reaction system (250L)
Huber Chiller x 6
Jilabo Chiller x 1
Gas Scrubbers x2

Reaction Workup

Rotoary Evaporator 20L
Filters: Nutsche DN450/100L
Tray Drying: Shel-Lab x 2
Grinding Mill, IKA
Jet Mill (MC Dec jet 100)
Certified Class D Clean room

Hydrogenation

High Pressure Parr (0.25-1L)
Parr 50 mL shaker
Micropacked bed reactors x 2
Buchi 30L Hastelloy 200 psi

GMP Material Storage

Controlled RT, 2-8 ℃, -20 ℃
3x Refrigrators; 3 x Freezers