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Better together: R&D and GMP analytics teamed up at anaRIC Biologics

Written by LVS on in the category Insights with the tags , .


Biologics are conquering the medical space. The need for high-quality analytical service companies for biological products has never been bigger. Unfortunately, fragmentation of expertise is a problem, as most of today’s players typically only offer specialized services. Ideally, you want a partner supporting you on all fronts throughout the entire development of your products. anaRIC Biologics got the message, and this new kid on the block offers a unique service: inventive analytics for your R&D phase that translate into solid GMP services when you are ready for clinical trials and beyond.

Biologics, such as antibodies, proteins, and peptides, are becoming more and more common in the medical world. They are the main assets for small, innovative biotech companies, and big pharma is also moving from small molecules to complex biological compounds. But whether you are a well-established pharma company, a biotech startup, or an academic research group, knowing your molecules is a must, and it's never too early to get an analytical expert on board. That’s where anaRIC comes in.

Biologics: relying on insights from small molecules will get you into trouble

“The development of biologics faces many challenges,” comments Koen Sandra, Scientific Director of the Research Institute for Chromatography (RIC). “The molecules are much more heterogeneous, and their complexity is of a very different order than small molecules. Many analytical service providers are focused on small molecules and struggle with the complexity of these new candidate drugs. We started with biologics quite some time ago and have acquired a track record in the field.”

Griet Nuytinck, Managing Director at Anacura, elaborates: “While the final goal is to deliver a solid package for release and for stability-testing of your products, there’s no such thing as a standardized approach when working in the biologics space! On top of that, data interpretation can be challenging, but it is nonetheless crucial to select the right set of techniques for the job. All of this must be kept in mind during your entire development process, from discovery all the way to marketing. Already during early development, future aspects of GMP need to be taken into account, and during GMP analysis, you need easy access to R&D data.”

Sandra: “One of our customers came to us for an extended characterization with a product already in phase II clinical trials. We unveiled several characteristics of their product that were completely unknown, and we were able to pinpoint the root cause of their problems. Strategic decisions depend on analytical outcomes (e.g. lead selection, process development, and formulation), so it’s very important to do your analytics early and thoroughly.”

Teaming up: R&D and GMP services in one

To offer customers a full package of services, very different types of expertise need to be combined. The research-minded RIC and the GMP specialist Anacura found natural allies in each other, and they decided to partner up under the name anaRIC, offering more than 45 years of combined analytical experience.

Sandra: “Our activities at RIC are R&D-based. We couldn’t offer a solution to customers asking for GMP services, as this would take us too far from our field of expertise. So, we started looking for a partner, and Anacura was the perfect match.”

Nuytinck: “We had been looking to move into the biopharma space for a while, but advanced R&D expertise remained a critical factor. That’s something you don’t just buy but need to build up over the years. We quickly recognized RIC as a highly complementary partner in the biopharma domain.

Our collaboration highlights the strengths of each partner. An R&D environment moves quickly, is innovative, and is prone to change, while people expect stability, standardization, and predictability from a GMP environment. By housing our operational activities separately yet close to each other, we can organize our R&D and GMP activities efficiently and can easily transfer information and materials in both directions.”

Thinking with customers and guarding product knowledge

Sandra: “By working closely with our customers as an analytical extension of their in-house teams, we build up significant knowledge about their products along the way. anaRIC ensures that none of this knowledge is lost.”

Nuytinck: “Size does matter. As a smaller, family-owned company, anaRIC is a very transparent and personal organization. We are flexible, and we accommodate our clients with real solutions and out-of-the-box thinking when needed. Our agility allows us to effectively tackle analytical challenges, which ensures that deadlines (e.g. for regulatory filings) are met. We actively help our customers save money and time.”

Sandra: “Customers also no longer have to worry about transfer of analytical methods from non-GMP to GMP environments, which can be an absolute nightmare when different parties are involved. Thanks to our integration of analytics and GMP, there’s no more of that hassle!”

You heard it here first: anaRIC is determined to be the leading provider of analytical services for biologics. As the first company to offer a truly fully integrated service package from research to market, they’re in a very good position to reach that goal. For more info on their services and activities, visit anaricbiologics.com to learn what they can do for you!

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RELATED ARTICLES
Market Access – the pitfall where innovations get lost

Getting your drug reimbursed by the government means the world. And gaining market access is a crucial turning point for many companies. However, …

POPULAR TAGS

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