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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Lyophilization is a pivotal operation in the manufacture of solid-dosage drug forms. 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.
By establishing a platform approach to process characterization, which has supported the successful approval of several marketed biologics, AbbVie scientists ensure the entire process is robust, right first time, and results in a highly consistent product to facilitate efficient BLA filing. AbbVie’s five-step process below offers a thorough understanding of the biologic and process control strategies to help 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. You’re putting your supply chain, your brand’s reputation, and patient safety in a partner’s hands. Here are some tips to increase confidence in your decision and ensure a successful outcome.
Whether your goal is to increase patient compliance, improve clinical outcomes, or to extend a product’s lifecycle, modified-release dosage forms present a solution to myriad challenges.
When executed properly, HME advances poorly soluble compounds in the development pipeline, without adding delays, cost, or significant post-processing activities, and can scale to commercial manufacturing.
To ensure that employee exposures are kept within accepted limits and protect the environment while containing costs, pharmaceutical companies and their contract partners who manufacture and handle high containment compounds must carefully select equipment, outline processes and procedures, and deploy appropriate containment technologies. Having standards in place for engineering controls is the first line of defense against harm from cross contamination or exposure to the patient, manufacturing employees, or the environment when working with HPAPIs.In this paper learn how to determine exposure potential and select the correct equipment and technology.
“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.”
Though the timelines may vary, across the globe more and more countries are requiring product identifiers and serialization of prescription drugs — right down to individual salable units. As global guidelines take full effect, it is worth understanding how contract manufacturing organizations are preparing themselves to comply to meet the needs of their customers.
Bilayer is considerably more convenient for patients due to receive multiple medications or longer-lasting profiles in a single dosage form and has the added benefit of improved patient compliance. This Q&A explores the manufacturing challenges, how to overcome them and considerations when selecting a CDMO for the manufacturing process.
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?
Strict regulations regarding the manufacture of HPAPIs require that pharmaceutical companies and CMOs carefully select equipment, outline processes and deploy appropriate containment strategies.
Done correctly, Process Characterization reduces the risk of manufacturing failures and regulatory delays. Scientists at the AbbVie Bioresearch Center (ABC) have established a platform approach to Process Characterization that has been proven effective as it has been used to support the approval of several marketed products.
There are a number of reasons to choose LBDDS over conventional formulation approaches when working with poorly soluble compounds. However, the range of lipidic excipients and the abundance of factors that go into determining which combinations of lipids, cosolvents, and surfactants to select makes LBDDS a complex, formulation-dependent technology. Know what criteria to consider when selecting a CMO to handle LBDDS manufacturing.
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.
Understanding and being able to control granulation is essential to the production of high quality pharmaceuticals. Fluid bed granulation and melt granulation can be tightly regulated to produce uniform material with a specified particle size therefore affording superior process reproducibility and better process control than many other granulation techniques.
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.