Archived Articles and Press Releases:

July 2005
Moving Forward with FDA's PAT Initiative
Genetic Engineering News (vol. 25, number 15)
by Angelo DePalma, Ph.D
Biotech companies have been responding slowly, steadily, but cautiously to the FDA's PAT (Process Analytic Technology) initiative. PAT is part of the agency's risk-based manufacturing proposal taht it hopes will propel pharmaceutical and biotech manufacture into the modern age.

July 2005
Peptide Manufacturers See Increased Growth
Genetic Engineering News (vol. 25, number 13)
by Vicki Glaser
Lou Bellafiore, President of TechniKrom, explains the applications of Apadtive P.A.T., including buffer blending, synthesizer design, and dynamic axial compression columns.
Adaptive P.A.T. is the company's real-time application of PAT to the process of peptide synthesis and purification. "The payback for our clients is both reduced regulatory oversight, by demonstrating true process knowledge and control, and increased yield of product, which can create a return on investment during the first run," says Bellafiore.

June 2005
New Developments in Purification Technologies
Genetic Engineering News (vol. 25, number 11)
by Angelo DePalma, Ph.D
"Interest in protein pruification has grown exponentially since completion fo the human genome project. Researchers operating at the milligram protien scale, and manufacturers prodicing hundreds of kilograms per year share a short wish list: purity and activity.
"'The FDA's recent initiative for science-based process controls to displace the incumbent approach of extensive end-of-process product QC now vindicates our approach [of adaptive P.A.T.],' says John Walker, VP of engineering. 'This demands a different class of equipment than most of those in current use since equipment based variability is part of the problem.'
"TechniKrom's buffer dilution/blending system manages rapid blending of a relatively small volume at a time, monitoring composition from co-streaming feedstocks at millisecond intervals, and using feedback control to finely adjust the control in real-time."

June 2005
Liquid Mixing: Solid Challenges
Pharmaceutical Manufacturing
by Angelo DePalma, Ph.D
"Bioprocess Chromatography is considered a high-risk operation because of variability in columns, chromatography resins and packing, and buffer flow and composition. TechniKrom, Inc. (Evanston, Ill.) has developed modular process skids which, through an innovative mix-and-measure scheme, minimize buffer variability. The idea: eliminating controllable variability (buffer composition) allows greater vigilance, and feedback, over more intractable sources of error.
"'We learned very early to focus on accurate, low variability blending, since in LC applications such as protein separations a very small change in the mobile phase has a big impact on quality,' says John Walker, VP of engineering. 'Only when the controllable variability elements have been driven out of a process can a developer clearly determine the underlying effects of the remaining parameter, and then design the appropriate process controls to guarantee quality by design.'"
View entire article on Pharmaceutical Manufacturing website

Click to go to Pharmaceutical Manufacturing Website.

March 2005
Buyers Guide - Product News
Pharmaceutical Processing
Upgraded Biochromatography Systems Feature Improved Accuracy, Reproducibility And Compliance
View article on Pharmaceutical Processing website

Click to go to Pharmaceutical Processing Website.

December 2004
Process Analytical Technology – PAT Blending System Helps Control Mobile-Phase Variation
Pharmaceutical Technology
by Kaylynn Chiarello
A review of how TechniKrom has integrated its process analytical technology into benchtop bioprocess and HPLC chromatography systems, and how the technology reduces both variability and eliminates the risk for fatal errors.
View article on Pharmaceutical Technology website (scroll to last page)

Click to go to Pharmaceutical Technology Website.

December 2004
Bioprocessing: A Critical Look at Bioproduction Approaches
Genetic Engineering News
by Angelo DePalma, Ph.D
Much has been written about biomanufacturing’s failure to keep up, technologically, with the complexities of and demand for biotech products. According to a survey by Ajaz Hussain, Ph.D., a deputy director at the FDA, biotech’s manufacturing efficiency is around 25%—far lower than in other process industries. While innovation has traditionally lagged due to regulatory uncertainty, comfortable profit margins shielded biotech from its production inefficiencies. Now, with the FDA encouraging innovation through risk-based manufacturing and process analytics, and with biogenerics looming, biotechnology can no longer be satisfied with business as usual. TechniKrom’s president and CSO, Lou Bellafiore, discusses the use of Adaptive PAT in downstream processing.

July 2004
Blend Controls Boost LC Performance
Pharmaceutical Manufacturing
by Chris DeMello, Centocor, and Lou Bellafiore and John Walker, TechniKrom, Inc.
A review with a case study of how Adaptive PAT™ (Process Analytical Technology) reduces reagent variability and improves liquid chromatography efficiency.
View article on Pharmaceutical Manufacturing website

Click to go to Pharmaceutical Manufacturing Website.

June 1, 2004
Bioprocessing: The Changing Oligonucleotide Marketplace
Genetic Engineering News
As price wars exert pressure to drive oligo prices lower, oligo manufacturers are relying on product-quality measures, delivery time, reputation, and product range to separate themselves from their competition. John Walker, TechniKrom’s VP of Engineering, discusses how the use of Adaptive PAT can be used to improve productivity and manufacturing costs in oligonucleotide synthesis.

December, 2003
Cambrex Bio Science Adds Services & Capacity
Genetic Engineering News (vol. 23, number 21)
by Peter Tunon
Cambrex Bio Science has added to its range of contract development and manufacturing services. TechniKrom's LC chromatography system provided the necessary mobile-phase blending and gradient control, while the adaptive dynamic axial compression columns provided the ease of use and reproducibility Cambrex was looking for.
View PDF of December 2003 Genetic Engineering News article

January 1, 2003
Bioprocessing Tutorial: Applying "Six Sigma" to Chromatography
Genetic Engineering News (vol. 23, number 1)
by Kevin Henretta, John Walker and Lou Bellafiore
By using Six Sigma to systematically identify and eliminate the sources of unnecessary variability in preparative liquid chromatography (LC) processes, it is possible to dramatically cut the cost of today's mainstream LC approaches while at the same time improving product quality and providing insurance against potentially catastrophic process failures. The article concentrates on the need for, and creation of, highly accurate and reproducible LC delivery systems in order to achieve world-class production scale LC performance resulting in lower production costs.
View PDF of Janaury 1, 2003 Genetic Engineering News article

October 15, 2002
Advances in Preparative Chromatography
Genetic Engineering News (vol. 22, number 18)
by Peter Tunon
Article provides an overview of the PREP 2002 Symposium at which TechniKrom exhibited, sponsored, and presented. TechniKrom is highlighted on page 18 mentioning firms utilizing a Six Sigma approach to uncover the hidden costs of large scale LC, its equipment providing isocratic and gradient mobile phase blending within 0.1% accuracy throughout full scale, versus the industry standard of 2-5% accuracy within a "sweet spot". Equipment offers 20- to 50-fold improvement in reproducible accuracy which has significant impact on process economics through increased product purity, recovery, and throughput, especially in FDA regulated environments with high value added products. Pay back on equipment investment is possible in a single purification for both clinical and commercial products. New 21 CFR Part 11 capable control software and many other features of columns and system skid are also discussed.

September 30, 2002
A Peak at HPLC
The Scientist
by Jeremy Peirce
The article begins on page 47 and provides a review of high-performance liquid chromatography techniques. Firm's president, Lou Bellafiore, comments on some of the causes of backpressures generated within an HPLC system.
View article on The Scientist website (membership required)

Click to go to The Scientist Magazine Website.

November 11, 2002
TechniKrom expanding services with contract purification for pharmaceutical and biopharmaceutical manufacturing
Press Release
Evanston, IL, November 11, 2002: TechniKrom Inc., a leading chromatography supplier for pilot scale and manufacturing, announced today an expansion of its contract services, with the addition of pilot scale and small scale chromatography purification. "We are now in a positition to help a client all the way from process development and validation of that process, through contract manufacturing", says Lou Bellafiore, President and CEO. Small and responsive, with expertise in systems engineering and in developing processes for the manufacture of pharmaceutical compounds, therapeutic proteins, small organic molecules, oligonucleotides and peptides, TechniKrom can help companies quickly develop, design and implement a cost effective separation process. The company's multi-purpose facility maintains automated analytical and preparative LC systems, dynamic axial compression columns, and has a total manufacturing capability up to kilogram quantities. Larger quantities purified under GLP or cGMP conditions are also available as is access to a class 10,000 cleanroom.

TechniKrom now offers a full range of both analytical and preparative services. The company can develop analytical assays to support discovery, clinical trials, process monitoring, formulation, quality control, and stability testing. It can now assist in a wide variety of manufacturing processes including full scale preparative purification of new compounds, isolation of impurities, and clean-up of natural products or synthetic intermediates.

With this expansion of the purification services the company's contract service mix is now perfectly tailored to developmental and early production needs of pharmaceutical, biotech, and fine chemical product development. It is TechniKrom's intention to complement the needs of the customers, and function as an extension of late stage research and early manufacturing. "We can get a manufacturing process up and running without a customer having to invest in a manufacturing facility", says Bill Paradise, executive vice-president business development "We are also in a position to to quickly step in and provide additional manufacturing capacity if demand for a product grows faster than expected. We work closely with our customers to both optimize the economy and throughput of a process, but we also work hard to control and reduce the environmental impact of our processes."

TechniKrom provides comprehensive IQ/OQ validation documentation packages, which are widely regarded as best in the industry. The validation packages are designed to meet FDA recommended protocols and requirements and reduce validation timelines from months to days. The packages come complete with all component manuals, test certificates and documentation and provide detailed testing reports on all validation procedures. Founded and managed by Lou Bellafiore, president and CEO TechniKrom, Inc., headquartered in Evanston, IL, is a privately held corporation dedicated to providing technologically advanced products and services to users of liquid chromatography. The company supplies the most advanced, reproducible chromatography manufacturing equipment and columns available for preparative work and full-scale manufacturing. TechniKrom has customers among the top US firms within the pharmaceutical, biotechnology, biopharmaceutical and fine chemical industries.

Managed and run by experts in liquid chromatography and engineering, the company has extensive experience working with engineering, development, and construction in the industry. TechniKrom is actively engaged in working with Six-sigma, a disciplined and customer-focused approach to continuous improvement of processes and products, and is now working toward ISO9001:2000 certification.