Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Adeline Siew, PhD

Rx-360, a pharmaceutical industry supply-chain consortium, is advancing approaches between pharmaceutical companies, suppliers, and contract manufacturers as a means to better secure the pharmaceutical supply chain. Pharmaceutical Technology discussed the group’s recent activities and upcoming goals with Brian Johnson, chair of Rx-360 and senior director of supply-chain security at Pfizer.

: Can you outline the key accomplishments of Rx-360 during the past year and what is planned in the near term? 

: We continue to see headlines around the world where criminals are putting patient safety at risk to make money through counterfeiting, product diversion, theft, and intentional adulteration. Substandard drugs with little or no active ingredient are being found at very high levels in the legitimate supply chains of many poor countries. Most experts and published data show that the problem is getting worse, not better. Globalization and increasing supply-chain complexity are contributing to the problem. It is time to take action and Rx-360 is leading the way. Rx-360 is a global nonprofit consortium of more than 80 companies and organizations with a mission to protect patient safety by sharing information and developing processes related to the integrity of the healthcare supply chain and the quality of materials within the supply chain. Rx-360 accomplishes its mission through education, sharing information, promoting best practices, and sharing audits. A few highlights from the past year demonstrate our commitment to action. 

. Rx-360 believes that educating stakeholders on supply chain risks and, more importantly, solutions is key for the industry to be successful. A great example is Rx-360’s recent “Protect Your Patients - Know Your Suppliers” campaign targeted at educating healthcare practitioners on the risks of product diversion. Rx-360 also conducted six free educational webinars for the industry this past year providing solutions and best practices for other supply-chain threats. 

. Supply-chain security is not a competitive advantage. Rx-360 believes that freely sharing information, such as alerts on potential supply-chain threats, is vital to the industry’s success. Over the past year, Rx-360 issued 14 alerts, including a potential heparin shortage, use of ‘gutter oil’ in China, toxins in glycerin, reports on Hurricane Sandy,  and Avastin (bevacizumab). [Gutter oil is a term used in China to describe  illicit cooking oil, which has been recycled from waste oil collected from various sources, such as restaurant fryers, drains, grease traps, and slaughterhouse waste; improper use of gutter oil involves its use in excipient manufacture.] Rx-360 also published 80 summaries of new guidances, legislation, and regulations. 

. It is not enough to talk about the risks; the industry needs to develop and share best practices. Over the past 18 months, Rx-360 developed and published seven white papers that contain the industries best thinking on various supply-chain security topics such as: preventing cargo theft; risks of drug shortages; tools for product diversion; auditing logistics service providers (LSPs); comprehensive supply-chain security programs; incident management processes; and monitoring the marketplace for threats--these examples are real solutions to real problems.

. Industry collaboration on sharing audit information and jointly conducting audits is crucial to improving the transparency of our increasingly complex and global supply chains. Rx-360 has completed and published almost 100 audits to date, and in 2013, we are on pace to double the number of audits completed in 2012, so we are quickly gaining momentum. Helping drive this initiative was the recent completion of a lean six sigma analysis of our audit programs and making modifications in the process to make it easier, quicker, and more cost effective for companies to use. Our new database is also coming online, which takes a manual process and automates it, leading again to a simpler, more efficient process for all involved. We are also launching a pilot to conduct good distribution practice (GDP) audits, which we believe will help Rx-360 meet an important industry need. Finally, over the past year, we have been promoting the licensing of Rx360 audits by making it easy to purchase an audit already conducted by Rx-360 and helping to defer costs that sponsors of the original audit incurred. This approach allows companies sponsoring an audit to put proceeds towards future audits, thereby, increasing capacity and lowering costs. 

For more information on Rx-360, including free tools and resources, see 

Articles

Rx-360, a pharmaceutical industry supply-chain consortium, is advancing approaches between pharmaceutical companies, suppliers, and contract manufacturers to better secure the pharmaceutical supply chain.

Rx-360 Advances Supply-Chain Security

Ensuring the quality of the pharmaceutical supply chain is of utmost importance to the pharmaceutical industry. The European Falsified Medicines Directive (FMD), which was adopted in July 2011, contains measures, which became effective in July 2013, requiring that all active substances manufactured outside the European Union (EU) be accompanied by a written confirmation from the regulatory authority of the exporting country. These statements are to be issued per manufacturing site and per active substance to ensure that standards of good manufacturing practice (GMP) equivalent to those in force in the EU are upheld. To gain insight on these provisions, two key industry groups, the Active Pharmaceuticals Ingredient Committee (APIC) and the European Fine Chemicals Group (EFCG), both sector groups of the European Chemical Industry Council (CEFIC), offered their perspectives on the strengths and weaknesses of the FMD. 

The European Falsified Medicines Directive (FMD) seeks to prevent falsified medicines entering the legal supply  chain in the European Union (EU). The directive was adopted in July 2011, and EU member states began applying provisions in January 2013. The purpose of the directive is to harmonize and strengthen safety and control measures across Europe in four main areas: safety features of medicines, the supply chain and good distribution practices (GDPs), active substances and excipients, and Internet sales (1-3). 

From July 2, 2013, all active substances manufactured outside of the EU and imported into the EU must be accompanied by a written confirmation from the competent authority of the exporting country that confirms that the standards of good manufacturing practice (GMP) and control of the manufacturing plant are equivalent to those in the EU (4). These requirements constitute one of the main areas of change of the new FMD to provide a clear legal basis for the concept of international cooperation on active substances, which is based on sharing responsibilities with local regulators (4). The written confirmation is required per manufacturing site and per active substance and should provide the following assurances:  

Standards of GMP applicable at the plant are at least equivalent to those in force in the EU. 

The plant is subject to regular and strict controls and effective enforcement of GMP, including inspections. 

Information on findings relating to noncompliance is supplied by the exporting third country without delay to the authorities in the importing country in the EU. 

The duration of validity of the written confirmation is established by the exporting non-EU country (4). As noted by the European Medicines Agency (EMA), these new requirements reinforce the need for pharmaceutical companies to ensure that the active substance manufacturers they are working with are registered with their respective local authorities and subject to adequate regulatory oversight (4). 

Additionally, the directive specifies that exporting countries with a regulatory framework equivalent to that of the EU will not need to issue written confirmations subject to approval. 

Following a request from a non-EU country, the European Commission (EC), together with GMP experts from member states and with the support of the EMA, will assess the regulatory framework of the requesters, and if the assessment is positive, the county will be listed as an “equivalent country” (4). As of July 2, 2013, four countries have been listed by the EC: Australia, Japan, Switzerland, and the United States. An equivalence assessment is ongoing for Brazil. Israel and Singapore have requested to be listed as an “equivalent country” (4). 

To avoid the risk of shortages of medicines if the required written confirmation cannot be obtained, the FMD provides for a waiver from the written confirmation in exceptional circumstances. The waiver can be used where an inspection by an authority of the European Economic Area has been carried out with a positive outcome and the issue of a GMP certificate (4). 

The FMD also puts into place measures on the distribution side of the pharmaceutical supply chain. It includes new responsibilities for wholesalers and a definition of brokering activities as well as new responsibilities for brokers. The EMA’s revised guideline on GDP, which was published in February 2013, includes specific provisions for brokering activities (1-3, 5). Reflecting the inclusion of GDP into European provisions, the EudraGMDP database also now includes information on GDP. EudraGMDP is a modification of the EudraGMP database, which was launched in April 2007 to facilitate the exchange of information on compliance and noncompliance with GMP among the regulatory authorities within the European medicines network. The new database, now called EudraGMDP, was a deliverable of the FMD. It is gradually being updated by medicines regulatory authorities in EU member states with distribution-related information and will be maintained on an ongoing basis (1, 5). The additional information will include: wholesale distribution authorizations; GDP certificates; statements of noncompliance with GDP; and registrations of manufacturers, importers (including information on their suppliers), and distributors of active substances (1, 5). 

Although the FMD took steps to fortify the supply chain as it relates to APIs coming into the EU, there is concern that the FMD falls short in adequately strengthening the inspection process for APIs imported in the EU. To gain a perspective on these issues, 

 discussed the FMD as it relates to API supply with representatives from the Active Pharmaceutical Ingredient Committee (APIC) and the European Fine Chemicals Group (EFCG), both sector groups of the European Chemical Industry Council (CEFIC), the trade association representing 29,000 large, medium and small chemical companies in Europe. APIC represents approximately 65 fine chemical companies, contract manufacturers, and pharmaceutical companies. EFCG represents approximately 40 small, medium, and large fine-chemical companies including four national and European industry associations: APIC; ASCHIMFARMA--the Italian Association of Manufacturers of Active Ingredients and Intermediates; CPA--Italy’s Chemical Pharmaceutical Generic Association; and SICOS, which represents French fine and biochemical producers (6-8). 

: Do you think the measures contained in the FMD are sufficient to ensure the quality of pharmaceutical ingredients coming into the EU or are there other measures that need to be taken? 

: No, the FMD does not sufficiently ensure the quality of APIs entering the EU. We have been very close to this topic since the FMD concept was born, and we remain concerned that, despite its objectives, it fails to fully meet the needs of EU patients with respect to product quality. Its effectiveness is still too dependent on industry’s supply chain self-evaluation and open to corrupt practices. Other measures that are needed include:

Stricter enforcement of existing laws by all member state regulatory authorities, plus tough sanctions to punish the violators

A consistent approach of member states when transposing the FMD into national law throughout the EU

A change in the existing laws to include mandatory inspections by competent authorities of all API manufacturers with the industry paying for extra regulatory resources if needed similar to the Generic Drug User Fee Act (GDUFA) in the United States

APIs contained in imported finished and semifinished drug products, mixtures of API with excipient(s) and semifinished (crude, moist) APIs should be included in the scope of the FMD. 

The EC should have rigorously tested its assumption that there are 15,000-20,000 API manufacturers selling APIs into Europe before they decided not to propose the mandatory inspection of all API producers. In fact, the Heads of Medicines Agencies survey of medicine manufacturers in Europe, published on Mar. 27, 2013, showed that the top 18 third-country manufacturers/exporters of APIs to Europe had only 1479 manufacturing sites (9). It is, however, never too late for the EC to re-consider mandatory inspections to better protect EU citizens and patients. 

: One concern raised by the FMD is the adequacy of enforcement measures, particularly the inspection process with the new directive lacking a provision requiring mandatory inspections of API producers in third countries (i.e., countries outside the EU). From an industry perspective, what are the advantages/disadvantages of the current inspection process of API producers in third countries? In what areas can the process be improved and at what level/jurisdiction should it be made? 

: The advantage of the current inspection process eases the continuity of supply of APIs from third countries for EU patients and, hence, avoids major product shortages. The disadvantage is the continued risk of substandard APIs/products entering the EU due to a lack of adequate enforcement and tough sanctions to punish individuals and companies. We suggest the following process improvements: 

Ideally, change the FMD to provide for mandatory inspections by EU authorities of API producers in third countries with industry helping to pay, or

Achieve the same end result by providing for mandatory inspections of third-country API producers by European authorities together with other country authorities applying the same EU GMP standards to share the inspection responsibility via mutual recognition agreements (e.g., US, Australia, and Japan) 

Inspectors should be trained to detect falsification or fraud, for example, facade constructions, ghost plants, and falsified official papers. 

: Earlier this year, the EU finalized a guideline on GDP for medicinal products in the EU. Although it addresses the distribution of medicinal products from an end-market perspective, the intent of the guideline is to further ensure the quality of medicines coming into the EU. From an industry perspective, what are the implications for suppliers of APIs and other pharmaceutical ingredients? 

: The industry must ensure transparency of sources and intermediaries (brokers and traders) and a register of evidence of compliance at each step along the entire supply chain from raw-material suppliers to the final medicine. Additionally, the EC published in February 2013 a draft guideline on the principles of Good Distribution Practices for Active Substances as part of the implementation of the FMD. Although this guideline only lays down the “principles” of GDP, it will be a step in the right direction. 

: From an industry perspective, as regulatory and industry groups seek ways to fortify the pharmaceutical supply chain in an increasingly global environment, what are the implications in the outsourcing relationship, either from the perspective of a sponsor company (i.e., pharmaceutical company) or contract manufacturer/supplier? 

: The sponsor company needs a contractor that it can trust to meet appropriate GMP standards in terms of product quality, quality culture, regulatory compliance with the laws of the country of product destination, and delivery at a price they are prepared to pay. Roles and responsibilities with respect to manufacture and distribution, including sub-contracting or use of third party distributors, should be clearly defined and understood by both parties. The contractor should be aware of the relevant regulations and should be able to comply with them. They must not fail their sponsor by delivering sub-standard products. 

: Can you outline key recent activities of APIC and EFCG in 2012 and 2013 in response to the EU FMD implementation and other measures that affect API supply into the EU? 

: APIC and EFCG have been very active  opposite the EC during the implementation of the FMD. We have written letters and made face-to-face representations to the EC’s Directorate-General for Health and Consumers (DG SANCO) to point out the continuing risks to EU patients (we are all patients) and to the EU API manufacturing base (our members). The latter suffer unfair competition mainly from Asian API manufacturers, many of whose facilities fall well short of the EU-required GMP standard (ICH Q7) (10). 

We have challenged the “loopholes” that remain within the FMD, which unless rigorously enforced by the various national regulatory authorities, will not prevent substandard APIs from continuing to enter the EU market, either as bulk API (requiring written confirmations) or through formulated products (where there is no separate check on APIs). We are pleased to note via DG SANCO that the national authorities in China and India have severely limited the number of sites for whom written confirmations are permitted. APIC and EFCG will continue to press for mutual recognition agreements with other countries (e.g., US, Japan, and Australia) that operate to the same GMP standards to help level the global playing field. 

2. EMA, “Falsified Medicines,” www.emaeuropa.eu/ema/index.jsp, accessed July 16, 2013. 

4. EMA, “Falsified Medicines Directive: Imported Active Substances Need Written Confirmation to Guarantee GMP Standards,” Press Release (July 2, 2013). 

5. EMA, “Key Deliverable of Falsified Medicines Directive Achieved,” Press Release (Apr. 8, 2013). 

6. CEFIC, “About CEFIC,” www.cefic.org, accessed July 16, 2013

7. APIC, “Objectives,” www.apic.cefic.org, accessed July 16, 2013. 

8. EFCG, “Membership,” www.efcg.cefic.org, accessed July 16, 2013. 

9. European Commission website, Mar 27, 2013, http://ec.europa.eu/health/files/committee/70meeting/pharm622.pdf, accessed July 27, 2013. 

Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

, Step 4 version (2000), http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q7/Step4/Q7_Guideline.pdf, accessed July 22, 2013. 

Industry groups offered perspectives on the strengths and weaknesses of the European Falsified Medicines Directive.

Implications for APIs in the European Falsified Medicines Directive

Scientists at A*STAR's Genome Institute of Singapore (GIS) have identified genes that could be potential targets for anticancer agents in the treatment of aggressive breast cancer. The findings were reported in a  

Patients diagnosed with triple-negative breast cancer (TNBC) have three important proteins missing, which account for higher relapse rates following treatment and lower overall survival rates. There is currently no effective therapy for TNBC and efforts to improve clinical outcomes have been hindered by the lack of effective targeted therapies. 

Scientists at A*STAR GIS have discovered that a protein tyrosine phosphatase, known as ubiquitin-associated and SH3 domain-containing B (UBASH3B), is overexpressed in one third of TNBC patients. This protein supports malignant growth, invasion, and metastasis, largely through modulating the epidermal growth factor receptor (EGFR). It has been found that UBASH3B is expressed in high levels in American and Asian patients, demonstrating that it is not specific to one ethnic group. 

, "The identification of target genes is always the most crucial first step towards treating a disease. It is heartening to know that UBASH3B is an important element of the pro-invasive gene network and targeting UBASH3B not only inhibits TNBC invasive growth, but also significantly reduces metastasis." 

According to Tan Tock Seng Hospital consultant surgeon Dr Tan Ern Yu, a collaborator and co-author of the study, while some patients may remain free of the disease, there are other TNBC patients who relapse after standard treatment; the ability to predict which patients are more susceptible to relapse is, therefore, crucial because these patients could benefit from more aggressive treatments. He pointed out that at the moment, doctors are unable to make such predictions reliably and further validation is needed to confirm whether UBASH3B can be developed into a means of identifying these high-risk patients as well as a new form of treatment. 

Dr Dave Hoon, Director, Department Molecular Oncology at the John Wayne Cancer Institute, USA, and co-author said, "Recent large-scale genomic analysis of breast cancer show that TNBCs are highly heterogeneous and patients’ tumors can have different molecular profiles. Unlike more common breast cancers that often express oestrogen, progesterone or HER2 can be targeted by specific agents such as hormone therapy or Herceptin. TNBC is the most difficult breast cancer to treat. The finding can help us develop new approaches for targeted therapy for this highly aggressive breast cancer." 

Scientists at A*STAR's Genome Institute of Singapore (GIS) have identified genes that could be potential targets for anticancer agents in the treatment of aggressive breast cancer.

Scientists Discover New Targets for Breast Cancer

 that it has opened a Phase I/IIa, multiple-site, two-cohort, open-label clinical trial in ovarian cancer at Roswell Park Cancer Institute (RPCI) in Buffalo, N.Y., and City of Hope (COH) in Duarte, Calif. The study will evaluate the safety, bioactivity and effectiveness of treating patients with their own T cells that have been genetically engineered to enhance antitumor activity. 

Adaptimmune has developed a unique enhancement technology for T cell receptors (TCRs), engineering them to target two cancer/testic (CT) antigens, NYESO-1 and LAGE-1. The TCRs will be transferred to the patients’ T cells in a process for autologous T cell manufacturing developed by Carl June, MD, and Bruce Levine, PhD, at the Perelman School of Medicine at the University of Pennsylvania. The process has been licensed to Adaptimmune and manufacturing will be performed centrally by Progenitor Cell Therapy in Allendale, N.J. 

 “T cells are the foot soldiers of the human immune system, attacking invaders like bacteria, viruses and cancer,” said Kunle Odunsi, MD, PhD, Director of RPCI’s Center for Immunotherapy and study chair, in a press release. “We believe that by modifying the T cells so that they express a high-affinity receptor for a protein that is a known cancer/testis (CT) antigen, we can fully exploit their ability as cancer killers.” 

The study is funded by Adaptimmune, who is the regulatory sponsor and owner of the T cell receptor technology, and will evaluate treatment in patients who are resistant to chemotherapy and/or have received more than two lines of chemotherapy for their ovarian cancer. Positive results have been reported for the same T cell product in sarcoma and myeloma studies earlier this year. 

A total of six patients will be enrolled in this ovarian cancer trial. Eligible patients are those who are capable of responding to the therapy (i.e., those with the correct tissue marker (HLA-A*0201) and whose tumor expresses NYESO-1 and/or LAGE-1). More patients will be enrolled if results from this clinical trial are promising. Additional study details can be found at clincialtrials.gov, under trial identifier number NCT01567891. 

Adaptimmune has opened a Phase I/IIa ovarian cancer trial to evaluate its genetically engineered T cell treatment, with enhanced antitumor activity.

Adaptimmune Initiates Phase I/IIa Clinical Trial in Ovarian Cancer

 and CPhI Pharma Evolution, part of UBM Live’s pharmaceutical portfolio, has 

 conclusions of the first monthly report. A survey on the current status of the formulations and ingredients market was conducted amongst high-level executives and experts from across the pharmaceutical industry during the last month. 

The report echoes the concerns of regulatory bodies, such as FDA and EMA, regarding the necessity of third party auditors to ensure the safety and quality of API and ingredients facilities. While nearly 95% respondents agree that supplier’s certification is important, only less than a quarter are actively working with third party auditors to vet suppliers, suggesting that the industry is still avoiding the problem despite the need for greater vigilance. 

Of those working with third parties, nearly 31% of respondents said they are working with USP’s Verified Ingredients Program; with 18% using EXCIPACT; and 10% using either IPEC or APIC. 

Girish Malhotra, CPhI expert industry panel member, attributes the industry’s lack of action to poor communication both internally and with suppliers. “People who are visiting supplier sites must be familiar with manufacturing and analytical practices, and both suppliers and buyers must agree on what certifications are needed,” Malhotra said in a 

Fellow panel member, Brian Carlin, pointed out that “the combination of concerns over quality, supply, and a lack of understanding suggest the need to move to more pharmaceutically aligned suppliers.” 

Quality was a top issue for 50% of respondents, with 41% adding that supply was a major issue with API and ingredients. Carlin, however, commented that problems with quality may not entirely be due to the lack of certification of ingredients. “If inconsistency of quality is due to unknown excipient attributes, beyond the certification of analysis, part of the problem may be inadequate feedback to suppliers,” said Carlin. 

It is well recognized that the pharmaceutical API and ingredients market is becoming more global and competitive. India and China are thriving as leading suppliers for APIs and ingredients, with 45% of respondents answering India as their source, followed by 25% for China, and 19% for Europe. However, changes in regulations mean that drug manufacturers will have to adapt their business strategies. “Companies in the EU and the US have to work with their suppliers to emphasize the value of quality. Quality can no longer be taken for granted and a signed paper is no guarantee,” said Malhotra. 

The report notes that outsourcing is a major trend across the industry; however, there is still a reluctance to use CMOs and CDMOs when developing new chemical entities for fear of potential IP infringement. According to the report, only just over a third of the industry is partnering with CMOs and CDMOs. Despite this, more than half of the respondents indicated that they are already working with CROs during clinical trials and nearly 40% are currently collaborating with academic groups in research and development. 

Bioavailability and stability remain as major obstacles in formulation as indicated by more than two thirds of respondents. With new drug targets becoming more complex, poor solubility and poor release are major concerns for more than half the pharmaceutical industry. 

Solid dosage forms of tablets and capsules still represent 70% of the market. According to 62% of respondents, they have focused their solid dose efforts onto extended release and orally disintegrating forms.  

The most difficult to control operations facing the industry are particle size reduction (60%) and tableting and compression (20%). One solution to this problem could be an increased use of cross-functional teams, with 21% actively hiring and 35% planning to hire more material scientists. 

 “Material science is a good addition to the diverse range of expertise required for good QbD,” stated Carlin. PAT and QbD are being used more in formulation projects with 35% saying they are using both and a further 36% planning to use them in the near future. However, panel member, Emil Ciurczak is critical about the hesitance within the industry and questions the “65% of respondents who are waiting to see if QbD really works when the concepts have already been proven to work in every other industry in the world, from cake mixers to cars.” 

Carlin, on the other hand, has a more optimistic outlook, as the FDAs Office of Generic Drugs is encouraging the adoption of QbD. “The ANDA checklist in being updated to include elements of QbD and as such ANDAs will not be accepted for filing without these elements.” 

“This report has highlighted some really striking findings that both suppliers and pharma need to take account of, particularly in relation to quality and inspections, as it is impossible in a globalized environment to inspect every pharmaceutical ingredients plant on the planet- so independent certification is a must,” said Chris Kilbee, group director, CPhI & Pharma. 

“Beyond this, it is clear that in terms of formulation for NCEs bioavailability and stability remain difficult to achieve with the proliferation of more complex drug compounds. And in fact, it is likely that as certification improves, pharma will increasingly look to outsource the development process and it is from this increased competition that solutions to formulation issues will be found. In the future, this will enable drug targets that were previously unworkable and reformulations of existing compounds to make it through the development cycle and on to commercial supply.” 

The report highlights a need for greater third party certification to ensure GMP vigilance.

CPhI Pharma Insights: Formulation and Ingredients Report

Molecular Profiles, a contract research and manufacturing organization, announced that it has opened its new facility in the UK following official approval from the Medicines and Healthcare products Regulatory Agency (MHRA). The company has invested £9 million in this new 30,000 square feet pharmaceutical production site based in Nottingham, which has been designed to handle a range of non-sterile dosage forms such as solids, liquids, semi-solids, and inhaled products. The facility also offers manufacturing services for highly potent compounds up to OEB 4 level with manufacturing batch scale of up to 30 kg. 

The facility will provide state-of-the-art clinical manufacturing capabilities to drug development companies worldwide, marking a significant expansion for Molecular Profiles after its spin-out from the University of Nottingham more than 15 years ago. There are six GMP suites, new laboratories and a dedicated clinical packing area to support clients' Phase I and II clinical trial projects. 

The manufacturing site not only complements Molecular Profiles' established formulation development expertise but also supports the company's strategic alliance with Onyx Scientific, which was formed in August last year and aimed at delivering end-to-end pharmaceutical development services from initial drug discovery through to the later phases of clinical development. 

Nikin Patel, CEO at Molecular Profiles, remarked in a 

 that the license from the MHRA for the new site is probably the biggest milestone for the company's business. "From a commercial perspective, we are very much open for business and have already received significant interest from companies looking to use our manufacturing capabilities to assist with their clinical trial requirements." 

Molecular Profiles was founded by a group of scientists and currently works with pharmaceutical companies around the world, providing advanced characterization, R&D and manufacturing services. 

Molecular Profiles has opened a new facility in the UK following official approval from MHRA.