Process Chemistry FAQs
What scale of API synthesis can Exemplify BioPharma perform?
Exemplify supports synthesis from milligram research scale through multi-kilogram GMP manufacturing. Our process labs house 10–100 L reactors, enabling seamless scale-up from early route scouting to clinical API supply. Typical GMP batches range from 2 kg to 5 kg depending on reaction complexity.
Does Exemplify offer non-GMP and GMP API manufacturing under one roof?
Yes. Our 18,500 sq ft facility in Cranbury, NJ integrates non-GMP process development suites with qualified cGMP production areas, allowing direct technology transfer and minimizing risk between R&D and manufacturing phases.
How large are your typical GMP batch sizes for API?
We routinely produce clinical-grade API batches in the 2–5 kg range using 100 L glass-lined and stainless-steel reactors. Batch sizes can be scaled to meet Phase 1–2 clinical supply requirements while maintaining full GMP documentation.
Can you support route scouting and route selection for new chemical entities?
Absolutely. Our chemists perform literature and experimental route evaluation to identify safe, efficient, and cost-effective synthetic pathways. We assess scalability, impurity profiles, and IP freedom during early development.
How do you approach cost-of-goods (COGS) optimization during process development?
COGS reduction is embedded in our route development strategy. We optimize atom economy, solvent selection, and work-up efficiency while minimizing chromatographic steps, ensuring the commercial route is robust and economically viable.
What types of reactors and reaction vessels are available in your process labs?
We operate cylindrical and round-bottom reactors ranging from 10 L to 100 L, equipped with automated temperature control and overhead stirring. Additional tools include microwave reactors, carousel reactors, and hydrogenation vessels.
Do you perform hydrogenation reactions in-house?
Yes. Exemplify’s process labs are equipped with Parr hydrogenators for both catalytic and pressure hydrogenations, enabling selective reductions under controlled safety systems.
Can Exemplify handle moisture- or air-sensitive chemistry?
Our laboratories are fitted with inert-gas lines and Schlenk apparatus for handling oxygen- or moisture-sensitive intermediates. We also employ glove-bag setups and dry solvent systems for anhydrous operations.
What is your approach to technology transfer to CROs or CDMOs?
We generate detailed process descriptions, critical parameter ranges, and analytical release specifications to ensure smooth transfer. Our scientists often support startup and troubleshooting at the receiving CDMO.
How do you ensure process scalability from gram to kilogram scale?
Each step is assessed for thermal and mass-transfer characteristics using small-scale calorimetry and pilot reactors. We apply DoE and reaction-safety analysis before scaling to GMP, ensuring linear performance at higher volumes.
Can you perform salt and polymorph screening for APIs and process intermediates?
Yes. Our solid-state chemistry group performs salt, co-crystal, and polymorph screening to select the most stable and bioavailable form. Screening includes solubility, hygroscopicity, and stability profiling under ICH conditions.
What is your experience with spike, fate, and purge studies?
We routinely conduct impurity fate-and-purge evaluations to demonstrate effective clearance of process-related impurities and genotoxic reagents. Data are integrated into regulatory control strategies and impurity justifications.
How do you apply DoE (Design of Experiments) in process optimization?
DoE is used to map design space and identify critical process parameters affecting yield and impurity levels. Our chemists employ statistical modeling to predict optimal ranges and establish robust control strategies.
Can you synthesize reference standards, metabolites, and impurities in-house?
Yes. Exemplify provides custom synthesis of analytical reference materials, metabolites, and degradation products. This capability accelerates method validation and regulatory impurity qualification.
What level of documentation do you provide for process development reports?
Each project includes comprehensive laboratory notebooks, batch records, and summary reports with full analytical data, chromatograms, and spectra. GMP batches are supported by executed master records and CoAs.
How does Exemplify manage parallel process chemistry programs for multiple candidates?
We assign dedicated chemists to each project and manage parallel workflows using a multi-FTE model. Resources are dynamically allocated based on milestone priorities to maximize efficiency and minimize idle time.
Are your chemists experienced in complex multistep synthesis projects?
Yes. Our staff includes PhD-level process chemists with expertise in heterocyclic chemistry, asymmetric catalysis, and scale-up of complex intermediates. Many have industrial experience supporting IND and NDA submissions.
Do you provide process chemistry consulting for IND or NDA submissions?
We offer CMC consulting that includes authoring process descriptions, control strategies, and impurity justifications for Module 3 sections of INDs and NDAs. Our experts also participate in regulatory meetings when requested.
How do you approach process robustness and design space definition?
Critical parameters are systematically evaluated through DoE and FMEA assessments. We define proven acceptable ranges and establish control limits consistent with ICH Q8 and Q11 principles.
Can Exemplify assist in developing commercial routes for late-stage programs?
Yes. Exemplify supports route optimization, impurity fate studies, and tech transfer to commercial manufacturing partners. Our work focuses on process economics, environmental impact, and long-term supply reliability.