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Successful drug development – getting it right from the start

Lee Han-soo  Published 2019.12.20  16:30  Updated 2019.12.20 16:30

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- The right choice in a partner is the answer

The following article has been provided by Vetter Pharma International GmbH as part of its public relations activities. Korea Biomedical Review has no relationship with and bears no responsibility for the contents and opinions in it. – Ed.

When it comes to successful drug development, today’s pharma and biotech companies, both large and small, have high expectations for their products.

However, the period from preclinical through Phase III can be unpredictable for new molecules. Getting drug development right from the start means paying strict attention to the many aspects as they relate to technology, project management and the economics involved.

A wide variety of questions, unexpected challenges and decisions need to be carefully and thoughtfully addressed since even the smallest detail can have a significant impact on a drug product’s later success.

For many companies, the challenge is often accepting the fact that there are going to be a number of possible implications in the future manufacturing and packaging that need to be solved upfront in order to prevent delay.

With so many intangibles, early planning with the end in mind is critical and can help avoid unnecessary and costly mistakes, saving valuable time and money.

The answer is making the right choice of a solution provider that can offer expert advice and services.

Vetter can accommodate the needs of its customers and support the clinical phases with various services, including packaging and process design, formulation support, feasibility and stability studies, technical and clinical batches, scale-up for phase 3 clinical trials and regulatory support

Chicago clinical manufacturing facility focused on quality, timeliness and technical expertise

Our U.S. facility, located at the Illinois Science and Technology Park in Skokie, IL., is a state-of-the-art manufacturing and clinical supply site that serves both pharma and biotech companies of every size with customizable solutions for drug compounds in any state of development from preclinical testing to phase 2 clinical trials.

Because the facility is firmly integrated into the Vetter global business, drug product transfers to the commercial production in Germany are possible.

Since becoming fully operational in 2011, the facility has experienced significant development. In just one year, the site has more than doubled the number of filled units and has demonstrated significant growth in the number of projects it has undertaken for customers.

Currently the facility has 50,000 sqf, including two cleanrooms, on-site lyophilizer, chemical analysis and microbiology lab, visual inspection​ and good manufacturing practice (GMP) storage.

The approach to drug product development at the facility is dependent on three key parameters – flexible, fast and efficient. As such, production is scalable and development is streamlined and the processes are designed to maximize production yield with the provided active pharmaceutical ingredient (API).

The facility makes use of disposables to save time and increased efficiency of production. Analytical services and quality assurance testing is aligned with regional and international guidelines with clinical drugs manufactured and tested to U.S. and European standards.

The facility is well-experienced in filling vials (both liquid and lyophilized) and syringes.

The manufacturing of a drug and its submission for approval is a complex and expensive process. That is why so many companies choose to outsource the process.

As such, the choice of a partner that can do quality work within the schedule and budgetary limits while handling the drug product safely is paramount.

Vetter’s Chicago facility remains focused on what is most important to its customers – quick project implementation, high yield and, most importantly, highest possible quality.

A testament to the level of customer satisfaction and quality of services is the fact that much of the facilities business is repeat business.

About Vetter

Headquartered in Ravensburg, Germany, Vetter is a global leading contract development and manufacturing organization (CDMO) with production facilities in Germany and the United States.

Currently employing 4,500 people worldwide, the company has long-term experience in supporting biotechnology and pharmaceutical customers both large and small. Vetter services range from early stage development support including clinical manufacturing, to commercial supply and numerous packaging solutions for vials, syringes and cartridges.

As a leading solution provider, Vetter appreciates its responsibility to support the needs of its customers by developing devices that contribute to increased patient safety, convenience, and enhanced compliance. Great importance is also given to social responsibility, including environmental protection and sustainability.

corea022@docdocdoc.co.kr

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