Nitto Avecia Pharma Services
The Trusted CDMO for Complete Drug Development Needs

Unlike other sectors, innovations in the pharmaceutical industry are never ‘made in the garage’ endeavors. Driven by the mission to save lives through safe and efficacious products, drug development is a time-consuming and expensive process with strict regulations and deadlines to meet. This is why, over the last few decades, the need for outsourcing research activities to contract development and manufacturing organizations (CDMOs) has been increasing in the industry, especially among virtual companies that require substantial support for their development process. While big pharmaceuticals and mid-sized companies have been outsourcing research activities, recently, due to COVID-19, they have started establishing a robust partnership with CDMOs to secure additional capacity and capabilities. Further, as large biopharma and pharma companies are involved in developing COVID-19 related drugs, they are trying to build more capacity with CDMOs, which have a full line of analytical and manufacturing capabilities. Thus, pharmaceutical companies need a reliable partner with superior expertise to successfully complete clinical development.

This is where Nitto Avecia Pharma Services comes into the picture. With 30 years of chemistry, manufacturing, and controls (CMC) experience, the company has established itself as a trusted CDMO, which offers an experienced team of professionals and robust capabilities to meet complete drug development requirements from IND—enabling to Life Cycle Management. Through these years, Avecia Pharma has earned its reputation for providing outstanding analytical testing from small molecules to biotechnology-derived products and Oligonucleotides, and guiding its clients to expedite their time to market. The company’s comprehensive package of good manufacturing practice (GMP) services includes parenteral manufacturing (liquid/lyo), formulation development, analytical chemistry, analytical development, biopharmaceutical development, stability storage/ testing, structural chemistry (including Extractables/Leachables), and microbiology. “We are a small and nimble organization with integrated solutions and extensive capabilities dedicated to product development,” says Aryo Nikopour, SVP scientific and technical services at Nitto Avecia Pharma Services.

With ‘creating wonders’ as the company vision, Avecia Pharma offers innovative and best-in-class services to mitigate clients’ unique challenges quickly and seamlessly. The company is extremely flexible and provides customized solution to its clients. It can simply translate the clients’ ideas into operations as required with timely adjustments and collaborate with them, providing expertise and necessary feedback. “Our experts bring in many years of experience and we are more than happy to share them with our clients. We strive to be a part of their program and their solution,” affirms Nikopour.

We are a small and nimble organization with integrated solutions and extensive capabilities dedicated to product development

The typical onboarding process begins with the discussion to define the project scope understanding the development needs and expectations. Next, detailed proposals are drafted with accurate descriptions of each activity, timeline, cost, and deliverables. With project management the core of Avecia Pharma’s business model, the company assigns a dedicated project management team or a person to act as a liaison between the client and the company. “With various groups supporting the client from release of raw material to matter development, there’s a definite need for project management to ensure requirements are met and be advocate for clients,” explains Nikopour. Further, highly qualified scientists perform the execution of work, and compliance with all quality and regulatory requirements is reviewed by a dedicated team of quality assurance professionals. Focusing on proactive measures, Avecia Pharma offers consultation throughout the project life cycle. Once finished, the company then provides monthly or quarterly based KPIs to measure quality attributes and remediate the issues encountered during product development, ensuring client success.

Highlighting the efficiency of Avecia Pharma’s services, Nikopour cites an instance wherein the company helped a client develop a filling process for a difficult-to-fill product that they had no experience with and wanted to accelerate the development process to meet an internal deadline for filing their IND. As the highly viscous product needed to be processed at elevated temperature, Avecia Pharma conducted a series of experiments to determine the necessary equilibration time for the product to reach room temperature. Various similar product-related challenges arose throughout the project, which the company resolved efficiently and helped the client meet their IND filing timeline. The client was beyond satisfied with the process as well as Avecia Pharma’s ability to quickly address each issue with a sound technical solution. Recently, the client has partnered with Avecia Pharma to work on their next product in the pipeline.

With its extensive core capabilities, Avecia Pharma has dedicated its world-class services to the clinical development arena and carved its own unique niche. However, what truly differentiates the company is its ability to step out of boundaries and bring in disruptive innovation. Avecia Pharma has been a pioneer in addressing the industry’s unmet needs and has actively invested in new technologies such as Cell-based Assay, CMC support for Gene Therapy, and CAR-T Products. Further, the company’s collaboration with Nitto Avecia, Inc., a leader in manufacturing and development services for oligonucleotide-based therapeutics, has established a core team of scientists and professionals to support product development for oligonucleotide drug products. Avecia Pharma is also backed by Nitto Denko Corporation, giving rise to its ‘One Avecia’ single provider approach. This allows the company to offer a full line of services and ensure seamless transfer of projects within the corporate entity.

Moving ahead, the company plans to continue identifying market needs and investing in advanced technologies to mitigate them. With the right mix of unique capabilities and approaches, Avecia Pharma is undoubtedly the trusted partner for pharmaceutical companies in their drug development journey.