ABOUT ABBVIE

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:

Biologics | ADC | Potent | Drug Product | Fermentation | Hot Melt Extrusion | Sterile Fill/Finish | Pre-filled Syringe | APIs

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

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.

FEATURED PRODUCTS/SERVICES

Sterile Fill/Finish Sterile Fill/Finish

AbbVie’s new aseptic fill / finish vial line located in Sligo, northwest Ireland, is approximately 130 miles from Dublin. This state-of-the-art line supports lyophilization for potent and biologics along with liquid fill vials. Equipment installation is underway with production commencing H2 2020.

Contract Manufacturing Capabilities Contract Manufacturing Capabilities

Ten state-of-the-art commercial manufacturing facilities in North America and Europe. AbbVie Contract Manufacturing offers a wide range of global contract manufacturing capabilities.

Drug Product Contract Manufacturing Drug Product Contract Manufacturing

Whether you’re developing a new chemical entity or a first-to-market generic, precise dosing and drug delivery is vital for success. Regulatory agencies and clinicians want to see well-characterized, reliable doses with good bioavailability. Patients/consumers often favor a controlled release dosage form, with easy-to-use packaging and taste-free consumption. Drug developers increasingly need to deliver on all these fronts and more, without compromising speed-to-market, in order to manage a successful pharmaceutical program. Direct benefits of pharmaceutical outsourcing and contract manufacturing allows developers to access both state-of-the-art technology and accelerate your time to market.

Contract Fermentation Services Contract Fermentation Services

Fermentation is a critical step in both drug and toll manufacturing, as companies look to produce the core compounds that form their eventual products. While it is possible to undertake this in-house, the expertise contract fermentation services provide can improve the quality, affordability, speed and scalability of your program.

High Potency Manufacturing High Potency Manufacturing

High potency manufacturing is an expanding field with a unique set of challenges. Safety remains a primary concern for those handling cytotoxic drug products, as well as the clinicians and patients down the line. Beyond safety, pharmaceutical companies need to plan ahead for how they will manufacture high potency drugs at scale, distributing the end-products worldwide with secure supply chains in place.

Biologics CMO Biologics CMO

With patients’ lives at the end of the pipeline, biologics contract manufacturing needs to be safe, reliable and consistent in supply. The developers of these large molecule drugs, however, are also operating in a highly competitive space. Speed-to-market is imperative, along with efficient processes and low costs. A lot of this will rest on the quality of the cell line development and the expertise of the biologics CMO you choose.

Antibody Drug Conjugates Antibody Drug Conjugates

When selecting AbbVie Contract Manufacturing, you are partnering with a leading developer and manufacturer focused on accelerating and mitigating risks to program timelines and on efficiently fast-tracking your program to completion. AbbVie’s mAb and ADC state-of-the-art facility and expert scientific team are located in Worcester, Massachusetts, where we specialize in treating your product as our own and have demonstrated the capability to optimize success from innovation through commercialization. In addition to our expertise, our customers also benefit from a simplified supply chain as both mAb and conjugation manufacturing are conveniently located at one site.

Hot Melt Extrusion Pharmaceutical Formulation Hot Melt Extrusion Pharmaceutical Formulation

Hot melt extrusion (HME) is a proven technology for bioavailability enhancement of poorly soluble API's. Unlike other formulation options, hot melt extrusion technology is solvent-free. By drawing on continuous processing, hot melt extrusion is more economical and can be used for abuse deference and taste masking applications. This can ultimately deliver a higher quality, more marketable pharmaceutical product — in line with your commercialization strategy.

Prefilled Syringe Manufacturing Prefilled Syringe Manufacturing

Fill-finish syringe manufacturing is one of the last steps in pharmaceutical commercialization. The goal here is efficiency and sterility. Companies don’t want to waste any of their carefully developed product and they don’t want to distribute poor quality prefilled syringes or contaminated formulas. Once established, high syringe manufacturing standards must then be maintained throughout the drug’s life span, to deliver a reliable supply for patients.

Bulk API Contract Manufacturing Bulk API Contract Manufacturing

The active pharmaceutical ingredient (API) is the foundation of a final drug product, and a key consideration as you consider contract manufacturing.
 

CONTACT INFORMATION

AbbVie

1 N Waukegan Rd.

North Chicago, IL 60064

UNITED STATES

Phone: 847-938-8524

FEATURED ARTICLES

  • Is Your Quality Agreement Fit-For-Purpose?
    Is Your Quality Agreement Fit-For-Purpose?

    Choosing to partner with a trusted CDMO for drug development and manufacture requires an established quality policy. That policy should address management responsibilities, risk management, documentation, change management, CAPA, process performance, and product quality. 

  • How Can Extrusion Benefit Your Pharmaceutical Oral Drug Product?
    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
    Keeping Pace With Increasing Biopharmaceutical Manufacturing Demand

    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?

  • Optimize Your Lyophilization Process Using Minimal Drug Substance
    Optimize Your Lyophilization Process Using Minimal Drug Substance

    Scale-up and technology transfer of lyophilization processes remain a challenge. 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
    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
    5 Steps To Accelerated Biologics Manufacturing And Robust Scale-Up

    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.

  • Patient-Centricity: A Drug Development Imperative
    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
    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
    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?
    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?
    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
    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 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
    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
    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?
    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
    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
    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.

  • What Are The Advantages Of A Lipid-Based Drug Delivery System (LBDDS) For Poor Bioavailability Drugs?
    What Are The Advantages Of A Lipid-Based Drug Delivery System (LBDDS) For Poor Bioavailability Drugs?

    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.

  • Using A CMO To Streamline Process Characterization
    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.