IND submission is a major milestone in the life of your drug. We can provide all supporting analytical data to help ensure a smooth application process.
We have the expertise, flexibility, and resources to provide a full range of pharmaceutical API custom development services at every stage of the lifecycle.
We can provide lab-, kilo- and pilot-scale manufacturing for preclinical studies and all phases of clinical trials, supplying milligram to kilogram quantities.
Cambrex brings more than 40 years of generic API manufacturing experience to its pharmaceutical partners. From our sites in Italy, Sweden, and the USA, we are a leading global supplier of generic APIs.
Drug substance tech transfer sounds so simple on the surface, but it’s a complex activity carrying a number of technical, regulatory, and quality risks.
At Cambrex, we provide a range of technologies equipped to solve your API manufacturing challenges, and we are flexible enough to handle the most complex molecules.
If you’re looking to outsource drug product development to a CDMO, you need a collaborative partner who will engage you deeply to understand the unique needs of your project.
From pre-formulation to commercial manufacturing and packaging, you can trust Cambrex to deliver your complex dosage forms with the perfect combination of technology, expertise, and collaboration.
At Cambrex, we offer a tried and trusted approach to technology transfer, for scale-up or when transitioning to a different facility.
We are equipped to take on projects at any size or scale, offering established pediatric formulation and development expertise and to-scale manufacturing capabilities.
Biopharma companies at all stages of development, rely on our expertise and broad capabilities to produce the clinical trial supply of drug products they need, when they need them.
We can support you, at any size or stage, with a range of primary and secondary packaging solutions.
You can rely on our extensive portfolio of analytical development solutions and testing services to rapidly advance your molecule for the greatest chance of success.
Cambrex offers a comprehensive suite of testing services for complex biopharmaceuticals including standalone analytical R&D, method validation, release testing, ICH stability, and routine QC testing.
We’re solid state chemistry experts who can deliver timely, phase-appropriate solutions to optimize the physical stability of your API, develop a more bioavailable formulation or overcome other challenges.
Cambrex’s experienced analysts are well-equipped to ensure microbial testing is of the highest quality for our customers and delivered with a quick and reliable turnaround.
Cambrex and Q1 Scientific’s stability storage and sample management capabilities provide a variety of pharmaceutical storage conditions, with walk-in and reach-in chambers that meet all ICH Q1A requirements.
Cambrex is here to support you in early-phase development. Our development experts apply their ingenuity and skill to address your unique challenges.
Our teams of creative problem-solvers work closely with you to accelerate drug development timelines, optimize processes, and meet regulatory requirements.
We understand that the commercial phase of drug development can be challenging, especially when it comes to manufacturing at scale and meeting changing market demands.
Cambrex is a leading global supplier of more than 70 generic APIs, as well as intermediates and derivatives.
Securing end-to-end biopharmaceutical testing services has become increasingly challenging for biopharma companies at all stages of development and commercialization — particularly small or emerging organizations. These companies may need to overcome several factors, including a lack of resources to conduct cGMP compliant testing in-house, concerns about contamination at all-in-one facilities, and/or difficulty commanding personalized attention from large CDMO partners.
Additionally, a multitude of different modalities exist within the biopharmaceutical market, including monoclonal antibodies, proteins, cell and gene therapies, antibody drug conjugates, oligonucleotides, and subgroups within those modalities. Thus, while biopharma companies may choose API or drug product manufacturing sites all over the world, it often is advantageous for them to leverage a single laboratory — with aptitude in all those areas — for analytical service testing, regardless of whether the company is hyper focused in one area or has several drugs in the pipeline.
Many biopharmaceuticals, especially in the cellular and viral spaces, involve complex and unique testing challenges. While some larger biopharmas may retain in-house expertise and equipment to execute some testing, the capital expense of buying equipment, maintaining cGMP compliance, and the ongoing cost of keeping experienced testing personnel on staff does not make fiscal sense for most companies. Further, even companies with some in-house capability can suffer setbacks due to inexperience, infrequent usage of the equipment, or a misunderstanding of shifting regulations.
The process of discovering and implementing solutions with a contracted lab partnership benefits from up-front discussions between the provider and the biopharma client, formulating a plan to accomplish the latter’s goals. This collaborative approach informs the creation of tailored solutions designed to overcome development and commercialization hurdles specific to that client Moreover, by not consolidating testing and large-scale manufacturing of the biopharmaceuticals it supports, a contracted lab’s focus can remain 100 percent on clients’ analytical testing needs. This dynamic also ensures impartiality in determining material quality: the lab can be stringent in its testing standards without being tied to production of the material.
For example, Cambrex’s process starts with initial discussions between our business development team and clients, a dialogue to help us understand their needs. As we develop proposals based on those conversations, we maintain continuous contact with the client. Thus, by the time the proposal has taken shape, they have a detailed understanding of its scope, how it addresses their stated needs, and where additional (previously unknown) needs may have been identified.
Weekly or biweekly meetings between our team and clients keep them constantly updated regarding ongoing projects through release and stability testing. These meetings also regularly examine — and help clients to understand — evolving requirements as their project advances through different phases, including in-process testing or environmental monitoring.
Real-time collaboration and communication become even more vital as projects move toward commercialization and agency testing requirements become more stringent. Accordingly, through each product or test service Cambrex provides, the client interacts with the same project manager (PM), who organizes testing even if it spans several Cambrex departments and sites — ensuring the client enjoys the simplicity of a single point of contact throughout the partnership.
This dynamic exemplifies a key aspect of the 360° approach to biopharma testing: prioritizing the human element. Even the finest technology, strategy, location, and instrumentation can fall short if CDMO and client teams are not aligned and communicative. Partnering with a contract lab (versus conducting testing in-house) not only helps to ensure quality by leveraging experienced testing professionals, it frees biopharma companies’ personnel to focus on their own core competencies or other projects.
Cambrex’s broad reach in supporting small molecule analytics, large molecules, and cellular- and viral-based therapeutics positions us well to devise creative solutions to our clients’ problems. This includes, when necessary, applying new bioassays and technologies. For example, a recent client required detection of a specific bioprocessing impurity and we innovated a novel approach to detect and quantify trace levels of that impurity using quantitative nuclear magnetic resonance (NMR).
Consider that our Durham, NC, site’s key technologies include gel permeation chromatography instrumentation coupled to a multi-angle light scattering (GPC-MALS) system, a capillary electrophoresis (CE) system, and a reproducible platform for nanoparticle characterization, which allows us to perform particle size analysis and distribution of viruses. These instruments are bioinert and have enhanced our service offerings. This state-of-the-art instrumentation is supplemented with spaces engineered to ensure segregation for testing of proteins, DNA, mammalian viruses, and bacteriophage viruses.
Meanwhile, our Agawam, MA, facility provides environmental monitoring of facilities, buffer and raw material release testing, and reference standard creation. We also offer clients in-process testing services, providing fit-for-purpose statements of analysis (as opposed to full GMP certificates of analysis) when needed. This input can be informative in optimizing their processes. When optimization requires changes to a client’s manufacturing process — which, in turn, may require supplemental validation studies — we can help clients identify their gaps and suggest options including re-validation, co-validation, or supplemental validation studies. In short, the Cambrex network (comprising 13 facilities globally) offers a tool for every job. The assembled toolbox means top-to-bottom integrated analytical support for clients as they move through different phases of their regulatory submission.
Cambrex also regularly reevaluates and bolsters its quality systems and safety procedures not only to ensure quality of service, but to maintain a high level of agility in managing a variety of projects (e.g., a portion of the Durham site quality systems has been designed specifically for our new Biosafety Level 1 [BSL-1] and Biosafety Level 2 [BSL-2] service offerings). We also have worked to improve processes related to biopharmaceutical workflows, including next-generation sequencing (NGS) polymerase chain reaction (PCR), and soon we will add digital PCR capability.
Cambrex offers testing for biopharmaceuticals and small molecules — including peptides, vaccines, proteins, oligonucleotides, and viruses. We are adept at navigating the challenges associated with technical development for clients’ chemistry, manufacturing, and control (CMC) packages, as well as able to support ongoing testing and release where the material is manufactured. Thus, even as our clients may change manufacturing partners between early development and commercial production, their analytics needs can reliably be fulfilled in one place.
Whether Cambrex is engaged by pharmaceutical companies directly or quality/life sciences consultants seeking testing-related guidance for their clients, we field projects at all stages of development and manufacture. Depending on the product’s phase of development and the type of pharmaceutical, their testing needs will change, and a 360° approach to testing offers the flexibility to readily adapt to those evolving needs.
Thus, before attempting to cover all testing in-house or spreading testing across laboratories (i.e., one lab for drug substance, another for drug product), consider engaging a boutique CDMO offering the ability to customize its testing services to the unique challenges of your pharmaceutical.
Our analytical development and testing experts are here to help you rapidly advance your biologic for the greatest chance of success.
In this webinar, we explain why stability is particularly challenging for biopharmaceutical products, an approach for the design of a stability study, and typical degradation mechanisms for these product types.