Process Engineering

Quality by Design (QbD) principles are applied throughout the process engineering of drugs, biologics and biotechnology products to ensure regulatory compliance and product quality. Our core responsibilities involve process design and optimization, process validation, scale-up and technology transfer, facility design, process control, and troubleshooting. We can deliver scalable cell culture and synthesis processes, optimizing purification and formulation processes, ensuring regulatory compliance, and implementing process monitoring systems for consistently producing safe, effective drugs, biologics, and biotechnology products.

Capabilities

01

Process Optimization

Optimization of synthesis, purification, and formulation processes using DOE, modeling, and analysis to enhance yield, purity and drug product quality
02

Process Validation

Process validation of drug manufacturing processes for compliance with cGMP, FDA, EMA and other regulatory requirements. This important process can be broken up into 3 phases: Process Design, Process Performance Qualification (PPQ), and Continued Process Verification. Once process validation is complete the formulation is now complete.
03

Design of Manufacturing Facilities

Design of drug manufacturing facilities (reactors, purification suites, fill/finish lines) and specification of equipment requirements
04

Scability & Technology Transfers

Scale-up and technology transfer of drug production processes from lab scale to pilot plant to commercial manufacturing. Our experience includes tech transfer strategy and execution, including documentation, from process development to scale-up to manufacturing. This includes transfer of processes to different locations.
05

Process Equipment Design 

Process equipment sizing, data sheets, piping & instrumentation diagrams, purchase specifications, vendor selection, bid analysis, engineering support during fabrication of equipment, acceptance tests, and validation. Implementation of process monitoring (PAT), process control and automation systems for consistent drug quality
06

Process Support 

We have extensive experience with manufacturing campaign support, problem root cause analysis, and issue resolution. We help write deviations, CAPAs, investigations, campaign summary reports, and annual reports. •
07

Documentation Support

When scaling from lab-scale to commercial production you need a robust technology transfer process. Tech transfer documentation typically includes process descriptions, process scale-up calculations,  a facility process layout, process flow diagrams, and an equipment list. Documentation is just one part of the tech transfer process, however, and Kymanox takes a thorough approach to tech transfer to make sure everything occurs as expected.

Voice of the Customer

"The Kymanox team is trustworthy, reliable, and competent."
DEVICE DEVELOPMENT LEAD
GLOBAL PHARMACEUTICAL COMPANY
"They make it make sense"
VICE PRESIDENT, GLOBAL REGULATORY AFFAIRS
"The team was responsive, adaptable, very communicative, and willing to do whatever we asked."
WILLIAM BOHNAKER
DIRECTOR OF OPERATIONAL EXCELLENCE AT A RAPIDLY GROWING BIOPHARMACEUTICAL COMPANY

Services Applied

Our service can be applied throughout the process design lifecycle and to the following areas:

Biologics

Biologics (therapeutic proteins, vaccines, monoclonal antibodies) cell culture, purification and formulation processes.

Small Molecule Drugs

Small molecule drugs including chemical synthesis, purification, formulation and drug product manufacturing.

Small Molecule Pharma

Small molecule pharmaceutical products for all routes of administration (solid and liquid oral, topical, transdermal system, parenteral, nasal, inhalation, drug-eluting implants).

Biotechnology

Biotechnology products (enzymes, probiotics, industrial enzymes) including fermentation and recovery processes.