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.
Operational Advantages Of Using Hot Melt Extrusion To Create Amorphous Solid Dispersions
The limited solubility of many modern drugs frequently translates to low bioavailability, making improved solubility a primary goal of oral dosage formulation development. Low aqueous solubility can be combated through preparation of an amorphous solid dispersion (ASD). This article explores spray drying and hot melt extrusion (HME) which are among the most widely applied technologies for producing ASDs.
How Can Working With An Embedded CMO Benefit Your Drug Product?
The right CMO can expedite market launch, and an embedded CMO offers many advantages over other CMO models, including access to the extensive capabilities and knowhow of the parent organization.
The Value Of Expertise In Aseptic Fill Finish Manufacturing Of Biologics
Aseptic fill finish manufacturing is one of the final but crucial steps between biopharmaceutical development and patient care, and it's especially critical for highly valuable biologic drug substances.
What Your CMO Needs To Know About Serialization And Aggregation
In recent years, the global pharmaceutical industry has been under intense pressure to enhance the safety, security, and continuity of the supply chain. This has required drug manufacturers and a vast range of supply chain partners to work collaboratively to improve supply chain transparency. The goal is to be able to track, trace, and authenticate products, and to assure prescription drug supply from the manufacturer to the patient. Partnering with a CMO that has applied traceability, serialization and aggregation standards across its own operations promises business continuity and speed-to-market that translate to a competitive advantage.
CMO As Partners For ADC Process Development, Scale-up, And Optimization
ADC programs can accelerate through clinical phases rapidly, making early preparation for commercial launch imperative. It's sensible to partner with a CMO with a strong biologics foundation.
Is Your Quality Agreement Fit-For-Purpose?
Partnering with a CDMO requires a policy that addresses management responsibilities, risk management, documentation, change management, CAPA, process performance, and product quality.
How Can Extrusion Benefit Your Pharmaceutical Oral Drug Product?
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.
Keeping Pace With Increasing Biopharmaceutical Manufacturing Demand
Today’s biologics pipeline is healthy, but forecasts indicate growth so robust the industry risks being ill-equipped to meet demand. Will contract manufacturers to rise to the demand challenge?
Optimize Your Lyophilization Process Using Minimal Drug Substance
Here's how advances in steady-state computer modeling and bench-scale lyophilization practices are driving process optimization with minimal drug substances.
Lyophilization Of Highly Potent Drugs: Facility and Equipment Design Elements
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.
5 Steps To Accelerated Biologics Manufacturing And Robust Scale-Up
A platform approach to process characterization ensures accuracy and results in a consistent product, which facilitates efficient BLA filing and acceleration to commercial scale.
Patient-Centricity: A Drug Development Imperative
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?
CMC Strategies For The Acceleration Of Commercial-Ready ADC Manufacturing
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.
Selecting A CMO: Top Considerations
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.
What Dosage Form Provides A Release Drug Control Rate?
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.
How To Increase The Solubility And Bioavailability With Hot Melt Extrusion?
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.
How To Avoid High Potency API Contamination
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 Contract Manufacturing Wins Life Science Leader CMO Awards For The Seventh Year
“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.”
Track-And-Trace In The Drug Supply Chain
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.
Q&A Bilayer Tablet Manufacturing
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.
Is Your CMO Ready For Serialization And Aggregation?
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?
Avoiding HPAPI Contamination
Strict regulations regarding the manufacture of HPAPIs require that pharmaceutical companies and CMOs carefully select equipment, outline processes and deploy appropriate containment strategies.
Putting The “Process” Into Process Characterization
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.
Advantages Of A Lipid-Based Drug Delivery System For Poor Bioavailability Drugs
There are a number of reasons to choose a Lipid-Based Drug Delivery System over conventional formulation approaches when working with poorly soluble compounds.
Using A CMO To Streamline Process Characterization
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.
Fluid Bed Granulation And Melt Granulation In Pharma Manufacturing
Affording superior reproducibility and control than other granulation techniques, fluid bed granulation and melt granulation can be tightly regulated to produce uniform material with a specified particle size.
Tackling The Challenges Of Biologics Development And Manufacturing
Read why it is critical to have the right manufacturing partner to minimize challenges as a therapies move from discovery to commercialization.
Small Molecule Impurities: A Control System Design Challenge For ADCs
Composed of both antibody and small molecule elements, ADCs have a complex structure from which many different impurities can arise.