Emergent BioSolutions

In this Drug Digest video, our speakers will discuss aseptic processing and the manufacturing portion of the process. Join the Drug Digest video to help prepare for manufacturing and barriers that arise in the aseptic process. Learn how open and closed isolators, surface decontamination, and automated aseptic processing relate to conventional aseptic procedures.

https://www.pharmtech.com/pt_w/improving-aseptic

Aseptic processing is important to almost every step of the manufacturing process for pharmaceuticals, like formulation, filling, and inspection (1). According to recent research, this market is expected to be valued at $83 million (USD) and to increase approximately 6.7% in the next ten years (2).

With more growth comes more challenges, and these industry practices need to be refined for the best execution with each pharmaceutical created.

In this Drug Digest video, Dan Strange, TBD, and Richard Denk, TBD will provide expert insights about aseptic processing and manufacturing, including barriers to automated aseptic processing, what the future holds for this area, indirect product contact parts, and open and closed isolators.


Ascendia Pharma. Aseptic pharmaceutical manufacturing: how it works. November 17, 2021. https://ascendiapharma.com/newsroom/2021/11/17/aseptic-pharmaceutical-manufacturing

Future Market Insights. Aseptic processing market. April 2023. https://www.futuremarketinsights.com/reports/aseptic-processing-marke

The ability to identify barriers in automated aseptic processing and aseptic processing in general

The ability to learn about different moving parts in the process, like closed system, isolators, indirect product contact parts, and surface decontamination

Problem solving: ability to develop a plan for solving the biggest barriers in the clean room for a more efficient manufacturing process

Awareness: ability to successfully pinpoint new approaches to aseptic processing and how to respond as a laboratory personnel/manufacturer

Aseptic processing and sterilization experts

Webcasts

Webinar Date/Time: Thursday, August 24th, 2023 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST


Improving Aseptic Processing and Manufacturing Needs

Articles

Moving a biopharmaceutical product from molecule-to-market is demanding in terms of expertise and capabilities needed throughout the development and manufacturing process. In this white paper, we explore the processes, operations, and customer-focused approach of Emergent CDMO's integrated internal teams, providing efficient organization alongside smooth and timely technology transfer and scale-up, from R&D to GMP manufacturing. 

Download our latest white paper to learn how partnering with an integrated CDMO can help create an efficient development services framework to achieve your drug substance and drug product manufacturing goals.


Streamlining Your Process Development Journey to GMP Manufacturing

With the manufacturing, packaging and quality control capabilities that you need available at scale, Emergent CDMO’s in-house drug product support services for clinical and commercial manufacturing help pave the way for your biotherapeutic or vaccine success. Flexible fill lines, single-use technologies, a large (and growing) production footprint, viral and non-viral platforms — an entire suite of capabilities from Emergent are ready to support your drug product manufacturing initiative. Plus, our size, adaptability, and expertise ideally position us to meet your needs as they evolve.

Our viral drug product manufacturing facility in Rockville, MD is home to the groninger® INTEGRA, a state-of-the-art high-speed fill/finish line. The INTEGRA offers integrated isolator technology and Biosafety Level 2 (BSL2) capabilities, in conjunction with an automated inspection, labeling, and packaging line, ideal for large scale fill/finish manufacturing of viral biotherapeutics and vaccines. The INTEGRA is an integral part of our strategic investment plan to support biopharma innovators in the fight against life-threatening viral diseases. 

The Vanrx SA25 Aseptic Filling Workcell is a state-of-the-art isolator fill line, providing our clients with a high level of sterility assurance and flexibility through an automated handling, filling, and closing process, designed to minimize line losses. If you have a high-value product and require a small-to-moderate batch size, the Vanrx may be the right fit for your program.


The groninger® FlexPro 50, located at our Camden site in Baltimore, MD is a state-of-the-art filling suite, utilizing isolator-based technology for the aseptic processing of drug products in pre-sterilized ready-to-use (RTU) syringes, vials, and cartridges. An inline lyophilizer minimizes user intervention through an automated lyophilization loading system. The FlexPro 50 enhances Emergent CDMO's commitment to providing excellence in aseptic fill/finish to meet biopharmas’ diverse needs. 

Our Development Services Center for Excellence in Gaithersburg, MD offers drug substance and drug product process development, analytical development, lab-scale manufacturing, and early-phase GMP release and stability testing. To learn more about Emergent CDMO's development services, 

take a 3D Virtual Tour of our Gaithersburg facility

A New Era in Viral & Non-Viral Drug Product Manufacturing

Emergent CDMO is dedicated to helping biopharma innovators bring lifesaving therapies to patients around the world. Our development and manufacturing sites in North America and Europe can support early to late stage production of biotherapeutics and vaccines. Whether you’re looking for initial process development support, small volumes of material for clinical trials, or large-scale production for a global commercial therapy, our experienced CDMO team is ready to serve as your trusted guide from molecule to market.

We support a broad portfolio of preclinical through commercial programs with experience in a wide range of platforms and technologies including mammalian, microbial, viral, plasma proteins, and gene therapy.



• Process Development

• Analytical Development

• Formulation Development

• Non-GMP Lab-Scale Manufacturing





• Upstream & Downstream Processing

• Single-Use Platforms (up to 4000L)





• Vials and prefilled syringes

• Lyophilization Services

• High Containment Filling (viral and non-viral)

• Packaging & Labeling


Customizable CDMO Solutions

A drug’s journey from development to manufacturing to patients is paved with roadblocks and potholes; many threats can derail bio/pharmaceutical processes. Potential solutions to such pitfalls have been discussed for years; however, few manufacturers have embraced technology and process advances to proactively ensure drug supply chain continuity.

The COVID-19 pandemic quickly brought supply chain and manufacturing deficiencies to light. The rapid deployment of select science- and technology-based solutions temporarily filled in productivity, communication, and supply chain gaps.

In this Technology Forum, the editors of Pharmaceutical Technology and BioPharm International share insight from process, manufacturing, and supply chain experts on promising and proven methods to ensure drug production continuity for small-molecule and biologic drugs.

Reinventing Small-Molecule Drug Process Development and Manufacturing

The COVID-19 pandemic and nitrosamines contamination emergency exposed vulnerabilities in the small-molecule drug manufacturing and supply chain. Efforts to enhance continuous manufacturing processes, new technologies for process intensification, and investment in drug manufacturing infrastructure are showing promising results. Hear experts discuss current trends, and how technology and process improvements can advance the development, manufacturing, and distribution of generic and innovator small-molecule drug.

Development and Manufacturing Strategies to Meet Biologic Drug Demand

Manufacturing capacity for biologic drugs, as well as fill-finish operations has been strained in the past year by demand for vaccines and therapies to combat COVID-19. Hear expert insight on how the bio/pharma industry is responding to the demand for materials, equipment, and manufacturing.

Understand strategies to for more efficient and effective small-molecule drug manufacturing

Review regulatory implications of the pandemic and strategies to comply with GMPs

Learn how demand for vaccines is impacting biologics drug manufacturing capacity, and ways to avoid roadblocks.

Session 1: Thursday, April 22, 2021, 10am EDT

Session 2: Thursday, April 22, 2021, 11am EDT

Session 3: Thursday, April 22, 2021, 1pm EDT

: Lonza, Emergent, Thermo Fisher Scientific, ILC Dover, Bora Pharmaceuticals, Patheon  

***Session 1: Thursday, April 22, 2021, 10am EDT, Session 2: Thursday, April 22, 2021, 11am EDT, Session 3: Thursday, April 22, 2021, 1pm EDT***  A drug’s journey from development to manufacturing to patients is paved with roadblocks and potholes; many threats can derail bio/pharmaceutical processes. Potential solutions to such pitfalls have been discussed for years; however, few manufacturers have embraced technology and process advances to proactively ensure drug supply chain continuity.  


Technology Forum Series: Strategies to Prevent Drug Shortages and Resolve Capacity Challenges.

Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Since 1998, Emergent BioSolutions has been a go-to source for solving some of the most complex and critical challenges in public health. From initial R&D and clinical studies to formulation, manufacturing and packaging, our experienced CDMO team at Emergent is ready to serve as your trusted guide from molecule to market.

Contract development and manufacturing (CDMO) services with support for mammalian, microbial, viral, plasma, and gene therapy.