Drug development for start-ups

In this written panel discussion experts in manufacturing in the pharmaceutical supply chain comment on the manufacturing landscape, how sustainable practices are being incorporated more readily, the challenges associated with this and the overall advantages. 

Your innovative drug. Our world-class production facilities. Discover the genius of working together.

Recipharm receives regulatory approval for the manufacture of a microbiome-based product for the prevention of Clostridioides difficile recurrent infection, under GenIbet Biopharmaceuticals and Seres Therapeutics. 

Moving from drug discovery into the early clinical development can be both challenging and time consuming without access to the necessary expertise. To perform a phase 1 study successfully, having drug substances and drug products (of the right quality) is crucial. In addition, the right knowledge and resources must also be in place, to ensure the fastest route to clinic.

We are approaching the end of a year which saw global vaccine rollout for COVID-19, 44 novel drug approvals (to date) and the return of the CPHI Worldwide in-person event.

Over the years, the prominence placed on creating a ‘greener’ future has increased dramatically. As a result, companies globally are facing growing pressure to adopt sustainable processes and reduce their carbon footprint. At Recipharm, we are taking a proactive approach to the situation and will be ready to adapt to any future changes of legislations, as well as supply challenges. 

Lyophilisation or freeze drying is an important means to improve thermal stability of a drug product, according to Thomas Becker, Quality Director and Qualified Person, Recipharm. This is particularly true for those that are thermolabile, such as mRNA vaccine candidates.

At Recipharm, we have the experience and appropriate licencing to support both development and commercial supply of cannabinoids. And, to further assist researchers and pharma companies working in this field, we have also developed new, synthetic routes to five different cannabinoids, including CBDA, CBGA, and three metabolites. In addition, we have identified a novel, scalable, synthetic route to CBD.

A summary exploring Recipharm’s key considerations when it comes to developing effective analytical methods for drug projects.

At Recipharm we have been supporting customers with their controlled substance projects for more  than 25 years. Our state-of-the-art manufacturing facilities have the infrastructure to safely and securely handle potent materials and we are approved to import, store, manufacture and export Class 1–5 controlled substances.

With so many outsourcing options available, selecting the CDMO that is the right fit for any particular sponsor company can be a challenging task.

nhalation development and manufacturing for early and late-stage clinical supply.

Recipharm Inhalation Solutions™ offers comprehensive contract development and manufacturing solutions for early and late-phase clinical supply from our stand-alone pilot plant as part of our integrated inhalation offering.

In January 2020 the European Commission published some proposed significant revisions to Annex 1, the EU’s good manufacturing practice (GMP) guide for the manufacture of sterile products. In the following three-month consultation period, affected organisations and stakeholders from over 70 different countries submitted more than 2,000 comments to the proposed update.

We understand the need for high quality and timely delivery and work with our customers throughout their development projects to ensure success. Our dedicated development facilities, cleanrooms for cGMP production of solid, liquid, and semi-solid formulations and sterile suites to produce sterile vials, allow us to cater for a range of clinical trials from Phase I to smaller Phase III trials. Large trials will be supplied from our commercial manufacturing sites.

Sponsors within the biopharmaceutical industry are increasingly turning to outsourcing for several reasons; remaining competitive and flexible within a quickly evolving sector, gaining access to manufacturing capacity and state-of-the-art equipment and scaling up to the commercial level are just three examples.

Bespak by Recipharm delivers market leading design, development, and manufacturing services for inhalation drug delivery devices to the global pharmaceutical market, at low, medium and high volume manufacturing scales.

In January 2020 the European Commission published some proposed significant revisions to Annex 1, the EU’s good manufacturing practice (GMP) guide for the manufacture of sterile products. In the following three-month consultation period, affected organisations and stakeholders from over 70 different countries submitted more than 2,000 comments to the proposed update. 

Bespak by Recipharm delivers market leading design, development, and manufacturing services for drug delivery devices to the global pharmaceutical market. Based in Cambridge, UK, our innovation centre is home to a team with diverse skills and expertise. Established to create new technologies that form the core around which we build and develop reliable, robust products, capable of meeting and exceeding our customers’ expectations with a focus on parenteral, nasal and ophthalmic routes of administration.

The CDMO inaugurates its new analytical laboratory under Recipharm Analytical Solutions

Recipharm offers inhalation and nasal product manufacturing in compliance with FDA and MHRA regulations. We offer contract manufacturing, packaging and supply to the global pharmaceutical market.Our dedicated team has more than 50 years’ experience in manufacturing inhalable products and supports our customers with the development and commercialisation of metered dose inhalers, dry powder inhalers and nasal sprays.

Medalchemy facility now fully licensed to import, cultivate, extract, manufacture and export medical cannabis flower and extracts

Bespak by Recipharm delivers market leading design, development, and manufacturing services for drug delivery devices to the global pharmaceutical market, at low, medium and high volume manufacturing scales. We have extensive experience in producing medical devices, including inhalers, nasal technologies, and auto-injectors, for some of the world’s leading pharmaceutical companies.

Move is part of US$500 million five-year investment programme by Moroccan government and consortium to establish vaccine and biotherapeutic manufacturing capacity in the country

Our E&L testing capabilities include analytical techniques designed to identify and test a wide range of additives and impurities, which could migrate from packaging to the drug product, potentially affecting drug efficacy and patient safety.

If you’re looking for news, product information and market trends from leading pharma companies, the CPHI-Online.com Company Showcases are a great resource for buyers who want to stay up to date, browse product portfolios and find the right partner.

Blow-fill-seal (BFS) technology is being explored for one-dose presentations of vaccines and other biologics, providing a continuous, automated process that can lower manufacturing costs, increasing access for patients worldwide. Other BFS benefits for biologics developers include enhanced automated processes with minimal human intervention, lower risk of foreign body contamination, and a high level of container integrity control during fill and finish. Manufacturers also appreciate the minimised risk of breakages during shipping and improved administration usability for clinicians and patients.
However, implementing BFS for biologics and vaccine projects comes with challenges: Ensuring chemical and physical compatibility of the container and the overall blow-fill-seal process with the drug formulation Demonstrating effective drug stability within the container Determining acceptable extractable and leachable profiles. In this session, we will explain how vaccine and biologics developers can overcome these challenges to harness the BFS manufacturing efficiency and patient convenience benefits.

The CDMO is already making certain investments to enable technology transfer and scale-up to commence imminently.

Find out how Recipharm developed a suitable analysis method for Lecigon® intestinal gel, a combination drug product containing three active pharmaceutical ingredients.

Recipharm is pleased to announce that the results of the study with Erdosteine as an add-on treatment for COVID-19 patients are now available.

Resyca, a joint venture between Recipharm and Medspray, is developing a novel type of soft mist inhaler devices, based on an existing primary packaging: glass pre filled syringes. This way we can utilise existing filling lines within Recipharm to do the aseptical filling. The lecture will describe the devices and the typical timelines for clinical and commercial supply.

Most pharma and biological companies perform their drug discovery, pre clinical and phase 1 clinical work with nebulisers and liquid formulations. By using a soft mist inhaler device, they can take a shortcut and reach the market sooner and with lower development risks. Resyca's soft mist inhalers have been developed with biologics formulations in mind, being able to deliver milligrams of drug in a single inhalation from a pocket size device.


Click here to register

The investment will support increased demand and help to secure new business at its Kaysersberg facility.

Sponsors within the biopharmaceutical industry are increasingly turning to outsourcing for several reasons; remaining competitive and flexible within a quickly evolving sector, gaining access to manufacturing capacity and state-of-the-art equipment and scaling up to the commercial level are just three examples. With so many outsourcing options available, selecting the CDMO that is the right fit for any particular sponsor company can be a challenging task. We speak with Frank Ternes, Chief Commercial Officer and Filip Ringborg, Director Contract Management & Operations Development, at Recipharm on best practice when it comes to selecting the right fit for your outsourcing requirements and how strategic partnerships built on trust are fundamental to success.

Global contract development and manufacturing organisation (CDMO), Recipharm, has announced a EUR 2.6 million investment for additional manufacturing capacity to support increased demand into its Kaysersberg facility.

As we approach the end of a year which saw global vaccine rollout for COVID-19, 44 novel drug approvals (to date) and the return of the CPHI Worldwide in-person event, we’re looking ahead to what 2022 has in store for the pharma industry. In this 60 minute, free-to-attend webinar, you’ll have the opportunity to hear from market experts from different sectors of the industry on the key trends, dynamics and disruptors we can anticipate in the coming year. Sourcing dynamics, the shift to self-administration, biotech innovation and sustainability are all high on the agenda – join us as we explore where the biggest opportunities and challenges lie and build your knowledge on where the industry is heading.

Recipharm, a leading contract development and manufacturing organisation (CDMO) has entered into an agreement with Arcturus Therapeutics, a leading U.S. based clinical-stage messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases. 

We have contributed to the design, development, and commercialisation of some of the world’s leading inhalation devices.

Portuguese pharma company, BIAL, and global contract development and manufacturing organisation (CDMO), Recipharm, have expanded a long-term agreement for the global manufacturing and supply of BIAL’s proprietary molecule opicapone.

This Learning Lab session was originally broadcast as part of the CPHI Worldwide Content programme, this session will explore: Design and realisation of lines for filling and lyophilisation of drug products Development of a lyophilisation cycle for an mRNA vaccine candidate in 2 months Reduction of lyophilisation cycle during optimisation process

Swedish life science company, Sobrera Pharma, and global contract development and manufacturing organisation (CDMO), Recipharm, have entered into an agreement for the formulation development and manufacturing of SO-001, a new oral treatment for Alcohol Use Disorder (AUD).

This session was originally broadcast as part of the CPHI Worldwide 2021 content programme. When we look at the evolution of the patient experience in drug delivery, we see that patients have traditionally been tethered to healthcare professionals, typically needing to visit a clinic to administer their treatment. With the arrival of new technologies, higher patient empowerment and better drug delivery mechanism, patients are starting to look for safe and more convenient manners moving toward self-administered rather than hospital-administered formulations. This session will explore: Growth, Competition, and Improved Access to Key Therapies Paving the Way for Increasing Advances in the Self-Administration Drug-Delivery Industry New Large-Volume Administration Devices Patient-Centricity Taking a Pivotal Role

In February 2020, Recipharm acquired Consort Medical plc, which included Bespak. The move was designed to strengthen Recipharm’s position as a leading inhalation company and one of the largest CDMOs in the world.

This Learning Lab session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme and will discuss: The challenging issues involved in analytical development using conventional detectors It will provide you with a broader discussion on non-conventional detectors and benefits from their usage The session will show some case studies involved in the development of methods using non-conventional detectors

CDMO says it has made "notable changes" to its supply chain processes to ensure continuing supply of medicines during COVID-19 pandemic

In this eBook, we will explore how drug developers can best identify and develop the right drug delivery device for their self-administered injectable products. We will also highlight the potential disadvantages of poorly designed devices. We will provide practical, straightforward advice around choosing the right device for the needs of self-injected products, and the considerations that need to be made to ensure optimum performance and long-term patient acceptance as well as highlight the added value of engaging device experts early in the design and development process.

Recipharm expects cost synergies of SEK 125 million (USD 12 million) from its recent acquisition of UK drug delivery firm Consort Medical and should realise them within the next 18 months, the Swedish contract research and development organisation (CDMO) said in an earnings call Thursday.

CEO says the acquisition of Consort Medical will help to create a leading advanced delivery systems company.

In recent years there has been a global focus on adopting sustainable processes, reducing carbon footprint and ultimately creating a ‘greener’ world for the future. The prominence placed on discussion around environmentally friendly operations has prompted widespread reviews of current practices across all industries, including the pharmaceutical industry.

We explore the challenges and pitfalls in developing new genetic vaccines, and in manufacturing them following approval. In addition, we discuss how strategic partnerships with expert contract development and manufacturing organisations (CDMOs) can support vaccine developers to bring their innovations to market.