Cambrex | Top CMOs in Europe 2021
Pharma Tech Outlook

Pharma Tech Outlook

Cambrex
A Trusted Partner Aiding Entire Drug Development Cycle

Cambrex: A Trusted Partner Aiding Entire Drug Development Cycle

Stephan Haitz, President CDMO Sales & Marketing, CambrexStephan Haitz, President CDMO Sales & Marketing
The COVID-19 pandemic has impacted society in many ways. On a positive note, it has helped to speed up a processing evolution that was already in play across the pharmaceutical industry, and it may even be improving public perception of the industry. As drug manufacturers race to create COVID-19 treatments and vaccines while also keeping other programs running, transparent collaboration and outsourcing to capable contract development and manufacturing organisations (CDMOs) play a critical role in enabling rapid commercialisation of new medicines. Drug developers increasingly rely on CDMOs, particularly for clinical trial manufacturing and where niche technologies are required. Integrated, end-to-end CDMOs, in particular, have also been essential players in the effort to bring COVID-19 therapeutics and vaccines to market rapidly. CDMOs help streamlining process and formulation development and scale-up to commercial manufacturing with their established expertise in all phases of the drug development cycle. In addition to accelerating the move towards supply-chain strategies favouring local CDMOs, COVID-19 has accelerated existing transformation trends, such as the shift from high-volume to smaller and increased investment by private equity firms in CDMOs.

Set against this backdrop is Cambrex. As a small molecule company, Cambrex provides drug substance, drug product and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,100 experts servicing global clients from sites in North America and Europe, Cambrex works as an extension of a client’s internal strategy—carrying out development or production so that in house teams can continue to innovate. Clients can work with the company’s experts to accelerate their small molecule therapeutics into the market. Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Additionally, the team has extensive expertise in drug development from early stages to clinical and commercial manufacturing and is driven to impact patients' lives positively.


Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing

In 2020 alone, a commitment to safety and quality in CMC work and the optimisation and validation of GMP processes helped clients obtain FDA approvals for multiple products.

Cambrex offers a range of specialist drug substance technologies and capabilities, including biocatalysis, continuous flow, controlled substances, solid-state science, material characterisation and highly potent APIs. In addition, Cambrex can support conventional dosage forms, including oral solids, semi-solids and liquids, and has the expertise to manufacture specialist dosage forms such as modified-release, fixed-dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile and non-sterile ointments.

Cambrex was recognised as a recipient in the annual CMO (Contract Manufacturing Organization) Leadership awards. Cambrex has received CMO awards for seven consecutive years, and this year has been recognised in the following categories: capabilities, compatibility, expertise, quality, reliability, and service. Over the last year, the pharmaceutical industry achieved great things– with the development, approval, production, and distribution of COVID-19 vaccines based on novel mRNA technologies in less than a year at the top of the list – providing tremendous hope for the future. During this highly challenging time, the learnings gained can be leveraged to accelerate the development and production of the countless medicines still needed by patients around the world. Here, CDMOs like Cambrex play a crucial role in bringing those needed therapies to market. The company is ready to partner in further innovation and drug development.

Keeping pace with innovations, Cambrex is ready to apply its broad toolbox to customer projects. The company’s team has extensive expertise in drug development from early stages to clinical and commercial manufacturing and is driven to positively impact the lives of patients. “In 2020 alone, a commitment to safety and quality in CMC work and the optimisation and validation of GMP processes helped clients obtain FDA approvals for multiple products. We will continue with the similar ethos,” says Stephan Haitz, President CDMO Sales & Marketing, Cambrex.

Cambrex News

Cambrex Nears Completion of 5-year, $100-Million-Dollar Investment Plan, One Year Ahead of Schedule

East Rutherford – Cambrex, a leading global contract development and manufacturing organization (CDMO), announced today that it is nearing the completion of a 5-year, $100-million-dollar investment strategy, one year ahead of schedule. The project, which adds more than 150,000 square-feet of capacity and capability expansions across 70% of its North American and European drug development and manufacturing network, will be completed by the end of 2024. The investments span all scales of clinical and commercial drug substance manufacturing and include advanced technologies to solve for challenges related to complex molecules.

“When we began this journey, we aligned our investment strategy to the future needs of our pharmaceutical customers. In addition to manufacturing capacity, we invested in specialized technologies to accelerate the development of highly potent APIs and complex synthetic candidates,” commented Tom Loewald, Chief Executive Officer at Cambrex. “I’m thrilled to announce that these capabilities and capacity will be available to the market well ahead of schedule, showcasing the efforts of our talented site operations and engineering teams.”

In North America, the 5-year investment strategy included capacity expansions in Charles City, Iowa and High Point, North Carolina, adding clinical and commercial manufacturing suites for small-volume, large-volume and highly potent API manufacturing. To support early development programs, Cambrex expanded its capabilities in Longmont, Colorado, co-locating analytical services in the same facility as drug substance and drug product development. Cambrex also added specialized technologies for continuous flow process development and complex synthetics in Waltham, Massachusetts.

In Europe, Cambrex expanded its research and development capabilities in Milan, Italy, with a new high potency lab for API process and analytical development, and commissioned a new stability storage facility in Liege, Belgium.

In 2024, Cambrex will complete the final phases of expansion in both North America and Europe, adding a new, modernized quality control laboratory in Charles City, Iowa and commissioning two new 6m³ scale production lines, representing a 50% increase in large-scale API manufacturing capacity, in Karlskoga, Sweden.

With these investments, Cambrex continues to be well-positioned to support its customers in the development and manufacture of innovative new therapies that improve human health.

Cambrex to Expand Stability Storage Business with New Facility in Durham, NC

Cambrex announced the expansion of its stability storage business, Q1 Scientific, which offers environmentally-controlled stability storage services to the pharmaceutical, medical device, and life sciences industries. Q1 Scientific will open a new state-of-the-art facility in Durham, North Carolina before the end of 2024, featuring advanced storage capabilities and co-located next to the existing Cambrex analytical facility.

The new Durham facility will initially offer 7 ICH stability chambers, covering a range of conditions including 2-8°C, 25°C/40%RH, 25°C/60%RH, 30°C/65%RH, and 40°C/75%RH, as well as both -20°C and ultra low (-70°C/-80°C) storage conditions. The phase 2 expansion, planned within the next 24 months, will increase the facility's capacity to 20 chambers, with the potential for 20,000 cubic feet of storage space when complete. The facility's Research Triangle Park (RTP) location in North Carolina will provide same day and next day delivery across the US.

Tom Loewald, CEO at Cambrex, stated, "We are thrilled to expand Q1 Scientific's reach into Durham, North Carolina, enhancing our ability to serve pharmaceutical companies across North America. This investment not only broadens our footprint but also leverages Q1 Scientific's extensive expertise in the stability storage business."

Q1 Scientific's expansion into Durham complements its existing facilities in Waterford, Ireland, and Liège, Belgium, giving it a global footprint with three locations covering both sides of the Atlantic Ocean.

Stephen Delaney, Managing Director of Q1 Scientific, added, "Operating three sites globally will be a significant benefit to our customers, who can now expect faster turnaround times for the return of samples and greater temperature-controlled transport options across the US and Europe."

Top 10 CMOs in Europe - 2021

Company
Cambrex

Management
Stephan Haitz, President CDMO Sales & Marketing

Description
Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Enjoy working with our experts to accelerate your small molecule therapeutics into the market. Cambrex offers a range of specialist drug substance technologies and capabilities including biocatalysis, continuous flow, controlled substances, solid state science, material characterization and highly potent APIs. In addition, Cambrex can support conventional dosage forms including oral solids, semi-solids and liquids and has the expertise to manufacture specialist dosage forms such as modified-release, fixed dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile and non-sterile ointments