When you engage AbbVie Contract Manufacturing, you’re getting more than a CMO. You fully access the capabilities of a highly experienced biopharmaceutical company. You know that your project will benefit from our broad range of capabilities and portfolio of state-of-the-art facilities in North America and Europe. Most of all, you know that your project will be reliably served by a business with a trusted reputation for innovation, reliability, compliance and delivery.
AbbVie Contract Manufacturing has over 40 years of experience as a pharmaceutical developer and manufacturer. We help domestic and global companies develop, scale, and commercially manufacture pharmaceutical products drawing on our extensive experience to accelerate time to market. Our services are comprised of:
As an embedded CMO, AbbVie Contract Manufacturing allows greater access to global manufacturing and a variety of scales and technologies. We handle your pharmaceutical products with the same dedication as our own and our partners realize the unique benefits of trusting a leading biopharmaceutical company with their contract manufacturing needs.
Above all, your project will benefit from a premier scientific team with the experience to meet complex challenges with demonstrative successful proven solutions.
As a multi-year recipient of Life Science Leader annual CMO leadership award for quality, innovation, productivity and reliability, AbbVie is ready to bring our experience to your business.
AbbVie has a 125-year history of patient care, as well as a focus on developing advanced therapies to address some of the world’s most complex disease states.
AbbVie’s expanded focus on biologics and targeted medicine allows us to use our knowledge and expertise to address difficult conditions that affect significant patient populations. Our priority is our patients, helping them lead healthier lives.
Founded on January 1 of 2013, AbbVie is a renowned biopharmaceutical company that began as part of the pharmaceutical leader, Abbott, which was founded in 1888 by Dr. Wallace Abbott to provide better care for patients.
At AbbVie, we have the expertise of a proven pharmaceutical leader and the focus and passion of an entrepreneur and innovator. The result is something rare in health care today — a global biopharmaceutical company that has the ability to discover and advance innovative therapies while meeting the health needs of people and societies around the globe.
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Customers choosing to partner with a trusted CDMO for drug development and manufacture can benefit from an established quality policy addressing management responsibilities, risk management, documentation, change management, CAPA, and process performance and product quality. Leveraging the expertise of a CDMO to assure product safety is a proven approach to product realization.
Due to its immense adaptability, extrusion has been widely utilized in diverse fields. It is being adopted more recently by the pharmaceutical industry at an unprecedented pace to address various drug product formulation and manufacturing needs. Read more about this exciting, complex technology its advantages.
Today’s biologics pipeline is healthy, but near-term forecasts indicate growth so robust, the industry risks being ill-equipped to meet demand. Can biopharma count on contract manufacturers to rise to the demand challenge?
Scale-up and technology transfer of lyophilization processes remain a challenge, but recent advances in steady-state computer modeling and bench-scale lyophilization practices are driving process optimization with minimal drug substances.
Because scale-up and technology transfer of the lyophilization process is challenging, it is important to develop a comprehensive understanding of critical lyophilization characteristics early on.
Establishing a platform approach to process characterization ensures the entire process is robust, right first time, and results in a highly consistent product to facilitate efficient BLA filing.This five-step process provides a thorough understanding of the biologic and process control strategies that accelerate time to a robust and reliable commercial scale process.
Success in biopharmaceutical development is ultimately about facilitating positive patient outcomes. How is patient-centricity influencing the development process today, and what role do CMOs play?
The potential for antibody-drug conjugate (ADC) programs to accelerate from early to late stage clinical development highlights the need to establish commercial launch-ready manufacturing early and efficiently.
Choosing the right contract organization to handle the development and manufacturing of a drug product is of critical importance. Here are tips to ensure a successful outcome.
“AbbVie is honored to be recognized once again as a top Contract Manufacturer by Life Science Leader,” said Azita Saleki-Gerhardt, Ph.D., President, Operations. “It is a privilege to achieve the top ranking in all six award criteria for the fourth year in a row. We are extremely proud of this achievement, as it recognizes our efforts to provide the highest quality and consistent support and services for our partners and their patients.”
While some are waiting for mandates for traceability, serialization, and aggregation, others are recognizing the inevitability of these strategies. Does your CMO have a dedicated traceability operation in place?
While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex.
Biologics offer distinct advantages that small molecule drugs do not, but they are far more complex to develop and manufacture. Read why it is critical to have the right manufacturing partner to minimize challenges as a therapy moves from discovery to commercialization.
Composed of both antibody and small molecule elements, ADCs have a complex structure from which many different impurities can arise. Drawing on existing ICH guidelines, a recent publication co-authored by AbbVie suggests a science-based approach that can be applied to the design of an effective control strategy for small molecule impurities in ADC therapeutics.