LinkChem
Setting New Standards in the CROSpace

Biopharmaceuticals are among the most sophisticated achievements of modern medical science. The huge, complex structures of these drugs are extraordinary in design and performance, offering higher drug efficacies and fewer side effects. As existing medical treatment archetypes keep evolving with monoclonal antibodies, recombinant proteins, and gene therapies, the biopharmaceutical research and development domainis also catching on to yield entirely new types of complex biologics.

But producing such complex biologics reliably at an industrial scale requires manufacturing and operational capabilities of previously unknown sophistication. Consider that most synthetic drugs are small molecules, which are composed of roughly 21 atoms. In contrast, biopharmaceuticals are typically thousands of times larger, containing 2,000 to 25,000 atoms. The formation of polymeric chains makes them much more structurally complex. And since the biologics are derived from natural and living sources, the cells must be kept frozen during storage, thawed without damage, and made to thrive in the unusual environment of a reaction vessel.

Biopharma companies are therefore increasingly looking for strategic partners that can aid them in such sophisticated drug discovery and development processes. Enter LinkChem. Based in China, LinkChem has a track record of success, corporate stability, and expertise in providing integrated contract research organization (CRO) and contract development and manufacturing organization (CDMO) services.

Connecting R&D And Manufacturing with a Unique C‘R’DMO Model

With personalized medicine becoming the main theme of the pharma industry, reliance on contract service provide drug makers to increase productivity and gain access to advanced technologies and expertise that are not practical to develop internally. Although demand for API development and manufacturing services is currently much greater than that for discovery, final-product formulation and production support, pharmaceutical companies are seeking more strategic partnerships with service providers that offer a broad portfolio of innovative and specialized capabilities.

But the CDMO industry is currently a very fragmented space. This is where LinkChem is making a difference by consolidating and combining a CRO + CDMO business model—creating a new global market standard based on the concept “CRDMO.” The “R” is forin-house research, as the key metric to ensure a successful connection between R&D and manufacturing, with the aim of becoming a one-stop shop capable of supporting outsourced projects across the entire drug development lifecycle, from discovery to commercialization.

The five reasons clients choose LinkChem as their CRO: quality of services, experience, capabilities, communication, and service cost. LinkChem adds business strength and innovation vitality as a CRDMO partner, by bringing in the expertise of industry veterans from diverse backgrounds. This aids them in meeting the research and development needs of its clients in pre-clinical, new drug research, while shortening the cycle and reducing the cost of drug R&D. All of its projects are operated under integrated project management with key contacts and weekly updates to keep its clients well-informed. LinkChem’s service flexibility, CRO+CDMO consolidation, and good communications help them to always exceed client expectations.

Linkchem Is Making A Difference By Consolidating And Combining A CRO + CDMO Business Model— Creating A New Global Market Standard Based On The Concept CRDMO

How Does LinkChem’s CRO+CDMO Services Benefit the Biopharma World?

For CRO services, LinkChem’s medicinal chemistry and organic chemistry experts extend support to pharma and biopharma companies in hit identification, hit-to-lead discovery, lead identification and optimization, structure-activity relationships (SAR) development, lead compounds synthesis, patent application preparation, and patent management. Given the critical impact discovery services have on the development of safe and effective product formulations and the reduction of cost and time to market, LinkChem’s superior CRO services can be a game-changer for biopharma companies in the APAC region.

Going beyond discovery, LinkChem also offers a whole range of CDMO services. Combining CDMO with the CRO services, LinkChem intends to help biopharma and pharma companies tackle the many hurdles throughout the drug development process, be it the shrinking clinical development timelines, increasing the need for rapid commercial scale-ups, or the convoluted regulatory pathways.

LinkChem can act as a one-stop outsourcing partner for pharmaceutical intermediates, from investigational to large-scale commercial development. The company caters to developing and optimizing innovative process routes, creating and verifying analysis methods, and registration support through all the stages of an investigational new drug (IND) application. LinkChem’s strategic CDMO services, combined with its team’s insightful experienceand careful, thoughtful approaches, help biopharma companies tackle every challenge, while identifying new business priorities, navigating the regulatory maze, and staying on top of the trends in a dynamic market. Many companies—especially small biotech companies—see LinkChem’s CRO+CDMO partnership as a meaningful way to augment their internal teams, resources, and manufacturing infrastructure on anad-hoc basis.

LinkChem also produces a wide variety of skeleton compounds, building blocks, raw materials, registered intermediates, and active pharmaceutical ingredients (APIs) for the entire drug development stage—pre-clinical, Phase I clinical, and late-stage clinical trials.

LinkChem supports the production of both pre-clinical as well as clinical projects governed by Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) standards. Biopharma and pharma companies can be confident of the supply stability as LinkChem has a vast infrastructure of manufacturing plants that attains the perfect combination of laboratory- and commercial-scale production.

The company also has an experienced regulatory affairs team to provide chemistry, manufacturing, and control (CMC) services during all research stages of IND, clinical trial phases (Phase I, II, and III), new drug applications (NDA), and abbreviated new drug application (ANDA). LinkChem provides post-approval regulatory services as well, such as product change, annual reports, and re-registration services.

“Leaning on LinkChem’s expertise, resources, and commitment, our partners keep their focus where it belongs—efficiently, swiftly, and successfully bringing new drugs for patients in need,” states Judy Lu, CEO of LinkChem. “In order to provide clients with better services, we also keep up with new developments and technologies in drug design and synthesis, such as proteolysis targeting chimera (PROTAC), antibody-drug conjugates (ADC), and photoredox reactions.”

A Culture that Breeds Success

LinkChem’s broad experience, on-demand resources, and state-of-the-art infrastructure keep their clients at the leading edge. In 2018, a large pharmaceutical company onboarded LinkChem to produce hundreds of tons of an essential intermediate product. A year later, the partner wanted a higher quality of the product (99.5 percent purity by high-performance liquid chromatography and single impurity less than 0.15 percent) at a lower rate. Within six months, LinkChem’s R&D team designed and developed a robust and scalable process that controlled the single impurities at 0.10 percent and reduced the cost by 40 percent.

LinkChem also has a reagent platform under the brand name Chemenu, which is playing a pivotal role in accelerating scientific research in China by developing novel building blocks, lab reagents, and chemical sourcing. Chemenu has a database with novel structures and diverse building blocks.Different from passive business models, Chemenu synthesizes in advance to make in-demand and valuable building blocksreadily available. At the same time, it integrates local resources to provide scientific research reagents with an aim to accelerate the development of new drugs.

Riding the wave of such competencies, LinkChem is considerably aiding pharma and biopharma companies to decrease their cost and time to market, while increasing profitability. LinkChem is the ideal partner for navigating potential pitfalls and staying on track with their clinical development goals.