cGMPnow
Full-Service Partner for ATMP Manufacturers

Advanced therapy medicinal products (ATMP) are constantly breaking new ground in modern medicine and the treatment of genetic diseases and disorders. A crucial need in the development of ATMPs is a GMP-ready manufacturing facility. However, when it comes to setting up such an infrastructure, manufacturers often need to work with multiple firms to cover the necessary subject matter expertise associated with facility design, GMP systems design, regulatory compliance, and GMP-readiness support.

cGMPnow is an advanced biopharmaceutical manufacturing company exclusively focused on addressing the problem of ‘too many cooks,’ which has historically plagued the GMP facility construction space. It offers a full-service solution to clients at various stages of developing their manufacturing capacity by bringing all elements of GMP facility design and construction under one roof, with the goal of establishing a GMP-ready infrastructure.

Drawing from extensive industry experience, it guides clients toward realizing their ATMP-facility manufacturing goals, taking them through the entire project lifecycle and full GMP regulatory compliance. It facilitates the design, construction, equipment procuring, setup, and qualification of GMP facilities to align with stringent regulatory standards.

“Through our end-to-end service, our goal is to accelerate the delivery of cell and gene therapy products to patients,” says Jeff Gilmore, CEO of cGMPnow.

Turnkey Solutions for GMP Systems

A large section of clientele benefits from its core offering, Turnkey GMP Systems. This integrated solution encompasses the specification and procurement of essential equipment, including quality control laboratory analytical instruments and manufacturing equipment. The company also provides the expertise to design and install GMP information technology/operational technology solutions and GxP Computerized Systems, enabling seamless integration with computerized platforms compliant with Part 11 regulations.

Among the many GMP-compliant platforms it specializes in, cGMPnow places specific emphasis on subject matter expertise pertaining to mRNA therapeutic products and their associated delivery platforms. Lipid nanoparticles (LNP) are currently the prevailing delivery mechanism for mRNA, and an internal team of experts is well-versed in the manufacturing processes required for formulating these LNPs and proficiently encapsulating generated mRNA at an early stage.

As the industry actively explores alternative delivery mechanisms that possess strategic advantages over LNP, peptides stand as a notable alternative. This emerging avenue holds substantial promise, particularly in oncology, where customized peptides can be designed to selectively target solid tumor cancer cells expressing specific antibodies.

This innovative approach is poised to become a prominent development in the industry, and cGMPnow is equipped with in-house expertise in peptide manufacturing.

This knowledge is rooted in the collective background of its team of chemical engineers with extensive experience in manufacturing peptide-based products. Drawing from this wealth of experience, cGMPnow channels its expertise toward developing and optimizing delivery mechanisms, positioning it to play a pivotal role in this evolution of mRNA therapeutics.

An example of cGMPnow's project management proficiency and its dedication to achieving results in compliance with regulatory and client-specific criteria is its undertaking of a comprehensive design overhaul for a client. The initial facility design, layout, cost estimate, and schedule for the project were already in place, and the client had requested an independent review of the design. cGMPnow conducted the review, revealing that it fell short of meeting regulatory requirements and lacked the necessary manufacturing capacity per specifications.

It proceeded with a comprehensive redesign of the facility concept layout to align it with the accepted industry standards and the client's manufacturing capacity needs. These enhancements were achieved without introducing additional costs to the project's overall estimate.

cGMPnow supervised the entire project since its involvement, leading it to GMP readiness and overseeing the onboarding of the initial client base into the facility. Its dedicated efforts culminated in the project's successful completion, delivered on time and well within the originally established capital budget. This achievement underscores cGMPnow’s capability to come in at the eleventh hour and still devise a successful plan of action that results in a fully functioning GMP-compliant facility.

A Guide to ATMP Facility Design

GMP real estate is the other side of cGMPnow’s offering; a solution for clients needing a facility built from scratch. The service begins with a search for suitable host facilities and up-front facility due diligence to verify if the infrastructure meets the requirements for the manufacturing facility buildout. This includes building size, utility feeds, floor-to-ceiling heights, floor and roof structural load ratings, loading dock quantities and sizing, parking space capacity, site access/egress, and zoning.

This is followed by feasibility studies and the concept design phase. During this stage, cGMPnow formulates a GMP-compliant facility layout, addressing the client's manufacturing and research and development needs. This phase also entails the development of an initial GMP equipment list, encompassing the requisite machinery and the design of automation and control systems. These elements are consolidated into a comprehensive concept design package outlining the project scope, estimated schedule, and cost estimate.

In the next step, the client typically engages an architect/engineer and general contractor for the facility's detailed design, permitting, and construction. cGMPnow continues to oversee the entire process, authenticating the manufacturing equipment, quality control equipment, and automation plan. Upon completion of construction, it carries out full facility equipment and computerized system validation.

Clients are supported with initial engineering runs, technology transfers of products into the facility, and the eventual establishment of full-fledged GMP operations.

A suite of post-implementation services is also offered, including support for achieving overall GMP compliance and readiness for regulatory pre-approval inspection (PAI) and ongoing operational efficiency enhancements, referred to as operational excellence improvements. Ensuring a seamless and efficient journey, from project inception to operational excellence, these solutions are tailored to cater to the diverse needs of each client.

This is especially true for startups and cell and gene therapy companies yet to develop clinical-use products, who encounter difficulties in securing funding for product development. cGMPnow comes to their aid with flexible and economical solutions for GMP facility design and construction, and by forging strong relationships with CDMOs to provide cost-effective solutions that cater to a diverse range of products and modalities.

Notably, through a strategic partnership with Vitrian, a GMP manufacturing real estate developer, cGMPnow enables the speculative construction of GMP manufacturing facilities. These can be leased to clients, reducing the initial capital expenditure, with the option to purchase the facility in the future.

At The Frontline of Regulatory Compliance

Regulatory compliance must go hand-in-hand with a GMP facility, and cGMPnow underscores its critical role by establishing a robust quality system and a meticulously crafted validation master plan. Within this framework, it adheres to a stringent process for evaluating the regulatory prerequisites for client facilities. The process is tailored to the modality and products slated for manufacturing and the intended distribution channels, whether they are destined for clinical trials or commercial sales.

As it predominantly caters to companies seeking market access in the U.S. and European regions, cGMPnow employs experts and engineers who remain current on updates and amendments to regulatory guidelines issued by the FDA and EMA. It actively participates in various industry institutions dedicated to monitoring regulatory changes, like ISPE, ISCT, Bio International, and ARM, ensuring it is well-informed and capable of delivering compliance solutions that align with evolving standards.

These affiliations encompass organizations such as the Alliance for Regenerative Medicine, which maintains dedicated workgroups oriented toward regulatory requirements. cGMPnow participates in these committees, which serve as platforms for in-depth discussions concerning emerging regulatory initiatives. This results in early access to forthcoming regulations, affording the opportunity to prepare for and, where feasible, contribute to shaping these regulations. Proactive involvement assures regulatory changes are anticipated and assessed for their practicality and potential impact on the company's client base.

The company also contributes to industry trade shows, where discussions surrounding existing and future trends take place. It offers insights into the current landscape and shares experiences gained from various executed projects, adding its success stories to the scientific community at large to fuel innovation.

cGMPnow empowers cell and gene therapy companies with outstanding GMP facility design through a dedicated client-focused approach. A track record of continuous success solidifies its role as a trusted partner in the journey to swiftly delivering ATMPs to patients and boosting healthcare outcomes worldwide.