Flexible CDMO: Small-Batch Drug Manufacturing for Clinical Trials in Europe

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

15 May, 2021

Please click here to request a quotation for your drug manufacturing project

Sofpromed understands the needs of biotech companies requiring small-scale batch manufacturing for drugs to be used in early phase clinical trials.

Through partnership with Synerlab, we facilitate flexible CDMO services for the production of small batches of drugs to be tested in phase I-II clinical trials as well as manufacturing capabilities for late-stage clinical trials and commercial batches.

Our service is characterized by fast responses to our clients, excellent customer support, and top quality cGMP drug manufacturing capabilities in Europe.

We can help biotech companies seeking to produce the following types of drugs:

  1. Solid oral forms
  2. Non-sterile liquid forms
  3. Semi-solid forms
  4. Sterile Injectable liquids
  5. Non-injectable sterile liquids
  6. Freeze-dried forms
  7. Beta-lactam antibiotics

1. Solid Oral Forms

Oral solid dosage forms refer to a final drug product therapy that is ingested through the mouth, dissolved in the digestive system, and delivered to the body through absorption into the bloodstream.

We use high-performance equipment for the manufacturing of solid drugs in the form of capsules, tablets, pills, micro granules, powders, and granulates. 

The equipment used is adapted to all batch sizes, which allows biotech companies the production of small batches needed in early phase clinical studies. 

We also have the capabilities to produce powder mixtures, granulations, and compaction.

Capsules

Capsules are a frequent form of dosage for oral administration of pharmaceutical and nutraceutical products. 

They are manufactured in different shapes and sizes, each capsule typically containing a single dose of active ingredient.

Common types of capsules include hard gelatin capsules, soft gelatin capsules, and modified release capsules.

As a leader in the manufacturing of capsules, we operate production sites based on two types of filling technology (trimming/force filling and compression measuring devices) that enable us to fill capsules with powders of different qualities. 

Our equipment is also adapted for the use of standard gelatine capsules or plant-based hydroxypropyl methylcellulose (HPMC) capsules.

We accumulate over 20 years of expertise in the manufacturing of soft capsules for drugs and food supplements.

Sachets

We are experts in the manufacturing of sachets.

Our clients can benefit from our industrial plant producing millions of single and double-compartment sachets each year. 

We have several production lines, which enable us to fulfil your requirements in terms of volumes.

Tablets

Our equipment enables us to manufacture tablets in sugar-coated, film-coated, orodispersible/dispersible, effervescent and chewable forms.

2. Non-Sterile Liquid Forms

Liquid dosage forms are pourable pharmaceutical formulations that contain a mixture of active drug components and excipients dissolved or suspended in a suitable solvent or mixtures of solvents.

We are able to produce non-sterile liquid forms and different batch sizes for drugs, medical devices, food supplements or medicinal plants. 

We produce syrups in large volumes (glass or plastic bottles) as well as other liquid forms such as non-sterile nasal drops (measured-dose spray or plastic bottles). 

We pack products in liquid stick packs, liquid sachets or single-dose vials.

Syrups

We possess a wide range of manufacturing and storage tanks with heating and cooling properties. 

These tanks are fitted with plate filters and cartridges. 

We produce all types of syrups in glass as well as in plastic bottles with aluminium caps or plastic stoppers.

Nasal drops

We are able to produce non-sterile nasal drops in plastic bottles with inhalers or measured-dose sprays.

Our production lines are highly efficient and adapted to fill different types of containers.

Liquid pouches and sticks

We have the technology to fill your liquid products in sticks or pouches. 

Our equipment is adapted to suit all requirements and all batch types. 

Our sticks and sachets are made from aluminium complex and may be packed in a simple cardboard box or a cardboard case.

Packaging of liquid forms

In summary, we can provide the following packaging for liquid forms:

  • Glass/plastic syrup bottles, aluminium caps or plastic stoppers
  • Liquid sachets
  • Liquid stick packs
  • Nasal drops: plastic bottle, plastic measured-dose spray or aluminium cap
  • Single-dose vials

3. Semi-Solid Forms

We offer our clients capabilities to manufacture semi-solid or topical forms.

Thanks to our tube filling line we can fill paste-type products such as creams, gels and ointments quickly.

Our production capabilities for semi-solid forms include creams, gels, and ointments.  

The types of packaging we handle for semi-solid forms include aluminium tube and the possibility of adding cannulas to tubes.

4. Sterile Injectable Liquids

We have extensive experience in the manufacture of sterile injectable liquids.

Our production unit uses high-performance equipment, together with aseptic and final sterilisation technologies.

We fill single-ended ampoules and glass bottles with liquid and include the final sterilisation.

We also possess several freeze-dryers to enable us to create injectable free-dried products.

Our production capabilities for injectable forms include liquids and solutions.

The packaging options for injectable forms include single-ended closed glass ampoules and glass bottles. 

5. Non-Injectable Sterile Liquids

We are leaders in the aseptic filling of non-injectable sterile liquids. 

Our laboratories have been manufacturing, filling and packaging all kinds of sterile or microbiologically clean solutions for ophthalmologic, nasal, oral, auricular and topical applications for almost 30 years.

Our manufacturing and packaging capabilities for non-injectable sterile liquid forms include glass and plastic bottles for conventional eye drops, plastic bottles for multi-dose eye drops without preservatives, glass and plastic spray bottles for disposable solutions, and plastic bottles for large volumes.

We manufacture liquid solutions packaged in glass or plastic bottles and multi-dose systems in different formats. 

We supply bottles with different stopper systems (twisting, crimping, setting, locking). 

Our eye drops are available in the form of conventional multi-dose dropper bottles for disposable solutions and multi-dose bottles and devices without preservatives.

We are able to produce glass and plastic bottles with spray pump (multi-dose device without preservatives) for nasal, oral, auricular and topical applications.

6. Freeze-Dried Forms

Our teams are skilled in the freeze-drying of pharmaceutical, cosmetic, and nutraceutical products as well as medical devices. 

We are equipped with numerous freeze-dryers of different sizes with a total freeze-drying capacity of over 220 m² with more than 1,000 m² of clean rooms. 

We can assist with your freeze-drying projects for pilot batches ranging from a few grams to several metric tons. 

We can help you with the formulation and optimisation of freeze-drying cycles and the production of all types of products.

Freeze-drying of pharmaceutical products

We have the capacity to manage all kinds of batches from small ranges to clinical trials and commercial batches. Freeze-dryers of different sizes, adapted to different production requirements are available at our production sites.

Freeze-drying of medical devices

We can develop innovative medical devices, from formulation to the development of suitable packaging for the end product. 

Freeze-drying allows for the development of devices which can release active ingredients with specific properties without adding any preservatives (activating of healing, enhanced absorption of exudates). 

Freeze-drying also allows products to be modelled in a chosen form.

Freeze-drying of cosmetic products

We freeze-dry cosmetic products to preserve unstable active ingredients in a hydrated, heat-sensitive environment: occlusive contact patches, gels in dry form, dry emulsion. 

Freeze-dried treatments penetrate the skin more effectively and have greater bioavailability.

Freeze-drying of ingredients

We can freeze-dry all ingredients used in cosmetics or food products such as: lactic bacteria, probiotics, donkey’s / mare’s milk, fruit purées, various plant and marine extracts.

Freeze-drying of reagents

We freeze-dry reagents in diagnostic products using bottles of different sizes.

Freeze-drying of active ingredients and pharmaceutical products

We freeze-dry raw materials used in pharmaceutical products and products derived from biotechnologies in bulk or in a workshop according to good European manufacturing practices as well as active ingredients, excipients, bacteria, biomasses, marine, plant and protein extracts, aqueous solutions and suspensions.

Freeze-dried forms

  • Solutions
  • Dressings
  • Patches
  • Haemostatic compresses
  • Sponges
  • Diagnostic reagents

Packaging of freeze-dried forms

  • Glass bottles
  • Bulk powder in bags
  • Blister packs (all types)

7. Beta-Lactam Antibiotics

Finally, we also have expertise in the production of beta-lactam antibiotics with production units dedicated to amoxicillin. 

We manufacture different galenic forms of beta-lactam antibiotics: capsules, tablets and powders for syrups.

We can produce beta-lactam products such as powders for syrups, capsules and tablets.

Our packaging of beta-lactam products include blister packs, glass bottles, and bulk powder in bags.

Please click here to request a quotation for your drug manufacturing project

For more information about drug manufacturing services, please contact us at info@sofpromed.com 

Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266  pledesma@sofpromed.com 

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Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266 pledesma@sofpromed.com