Streamlining chromatography and data management for FDA approval

For more than a quarter of a century, the USA’s generics pharmaceutical industry has been providing its Food and Drug Administration (FDA) with approved generic versions of brand medicines. Manufacturers of generics must prove to the FDA that their versions of a medicine are genuinely ‘bioequivalent’ to the original in every way, from active ingredient to route of administration and dosage. This requires working in a highly regulated, FDA-compliant analytical environment, where only the best laboratory techniques and data management software will suffice. Based out of Westminster in the U.S. state of Maryland, WES Pharma is an emerging specialty pharmaceutical company focused on producing difficult-to-develop liquid and solid generic medicines. It operates across the whole drug development pathway from early-stage R&D to product manufacture and its staff face a substantial analytical challenge dominated by chromatographic techniques such as HPLC and GC. Dr. Anna Razynska and Dr. Satya Ganti are Director of Analytical Sciences and Vice President of R&D respectively at WES Pharma, and know first-hand what a difference the right analytical technologies and data management tools can make.

Comprehensive data acquisition, processing and reporting are vital when filing new drug products with the FDA. Image ^© Anawat Sudchanham 123rf.com

Streamlined chromatography

WES Pharma’s focus on both liquid and solid generics of many types means its staff have a substantial chromatography workload and therefore a high demand for cutting-edge, compliance-ready software for data analysis. Advanced data acquisition, processing and reporting that simplifies the management of chromatography test results is therefore vital to the success of the company in filing to the FDA.

Razynska and Ganti both have experience of using different software to manage chromatography data, but Ganti played a key role in WES Pharma’s adoption of one data management tool in particular – Waters Empower^™ Chromatography Data System (CDS), which has now become a ‘staple’ among scientists in multiple disciplines. “I chose Waters because of the different features that it offers, its flexibility and its user-friendly interface,” Ganti says. She adds that the software’s industry compliance (to CFR-21) was also a key factor in the company’s decision.

Empowering software from a technology leader

It turns out there are numerous other reasons why Waters Empower^™ Software was the chromatography data management tool of choice for WES Pharma’s complex workflows, including ease of use, as Ganti attests: “Just by looking at the software, handling it and using it, within a week anybody can learn and go.”

Whatever challenges generics development has thrown up, it appears there has been a solution in the software that has enabled Razynska to put the data together. “For me, the person who is writing a report, easy presentation is the key,” she says. “If I need to include any chromatogram, the analyst can immediately go to the software, edit the picture and I can add to my report.”

The easy retrievability of data is a feature of the Waters Empower^™ Software that has transformed WES Pharma’s work since the early days of manual calculations using Excel. It has also been welcomed by the regulatory authorities, for whom documentation and presentation are all-important. “This software is a big boon for us,” Ganti says, “it can do almost everything that we want.”

A great working relationship

Great technology is an asset but allied to excellent customer service it can be transformative, as Ganti has found: “Waters software is always flexible, such that we can expand easily from one server to another. Being in this industry where I want changes to happen literally overnight, I know I can work with Waters and get it done,” she says. She further adds that “everything happens either the same day or the next day. If I need immediate help, we get it. I would say it has been a really great experience working with Waters.”

Razynska is also effusive in her praise of Waters, asserting that, “from a technical point-of-view, I never had a problem with Waters in my whole career, and I have been in the business many, many years. I remember still chromatograms when we were cutting and weighing the paper!”

Razynska and Ganti both add that Waters’ free training seminars across the state at Columbia are a very welcome feature of its service, covering data integrity and chromatography in general.

Future developments

Razynska is in no doubt where the future of analytical methods for pharma lies, when she says: “Computerization, computerization, computerization. Connect data through a large enough database and the computer will be able to calculate what’s going on, predict outcomes and tell you what has to be changed.”

Ganti agrees: “Detecting trends and making extrapolations is the future.”

Satya Ganti, Ph.D., Vice President of R&D
Dr. Satya Ganti is an experienced generic pharmaceutical industry professional with strong in-depth knowledge of product development process (ANDAs & NDAs 505 (b)(2). Her current responsibilities include API sourcing, pre-formulation, scale-up, clinical batch manufacturing, coordinating pilot and pivotal biostudies, ANDA submission, post-submission and post-approval FDA correspondences and post-approval technical transfer to commercial production.

Anna Razynska, Ph.D., Director of Analytical Sciences
Dr. Anna Razynska has extensive experience in chemical, biochemical, organic and analytical chemistry within the pharmaceutical industry and has worked across process improvement, quality assurance and ANDA applications. In her role at WES Pharma, Razynska has designed, directed and supervised analytical activities for ANDA submissions for solid and liquid products. She has also directed release and stability testing in compliance with regulatory requirements, managing and analyzing data for regulatory submissions.

Find out more about the work of the WES Pharma and how Waters Empower^™ Chromatography Data System could help you.

Read more interviews with the scientists using Waters Empower™ Chromatography Data System

• Achieving compliance in pharmaceutical manufacturing with cutting-edge data management: An interview with Rachod Thakolsri, Managing Director, Biolab Thailand and Dr. Aleem Ahamed, SM Biomed
• The cloud chromatography data system driving global operational efficiency at Amway: An interview with Caryn Weiss, Senior Research Scientist, Innovation and Sciences, Amway