About company[ 1.5 ]Contract development

R&D Laboratory (R&D)

In 2005, in order to develop, incorporate into manufacturing and register original, safe, effective and high-quality medical products and generics OJSC AVVA RUS’s R&D Laboratory (R&D) was founded. OJSC AVVA RUS’s R&D is a unique laboratory combining analytical facilities and equipment for pharmaceutical development of medical products. R&D laboratory follows the up-to-date pharmaceutical regulatory documents and quality systems like ICH Quality Guidelines, WHO guidelines; Good manufacturing practice (GMP), ISO/IEC 17025:2005 (National State Standard ISO/IEC 17025-2009) General requirements for the competence of testing and calibration laboratories; National State Standard P 52249-2009 Good Manufacturing Practice for Medicinal Products; Good Manufacturing Practice for Medicinal Products (Order by the Ministry of Industry and Trade of the Russian Federation #916 as of 06/14/2013).

The quality system is implemented within the laboratory and is maintained in accordance with the below mentioned requirements:

  • ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories.
  • Order #682 by the Ministry of Economic Development and Trade as of 10/16/2012 ‘On Approval of the Criteria for Accreditation of the Certification Bodies and Testing Laboratories (Centers) and Requirements to Them’.
  • National State Standard P 51000.4-2011 General Requirements to Accreditation of the Testing Laboratories.

Key R&D’s objectives:

  • Mastering new types of products. Development of composition and technology of new medicinesmedical products and their introduction into manufacturing.
  • Improvement of the existing technological processes. Testing of medicines medical products, pharmaceutical substances, excipients.
  • Testing of medicines medical products and pharmaceutical substances stability.
  • Development and validation of analytical methods to control medicines medical products quality.
  • Preparation of documents for registration dossier to certify new medicines medical products.
  • Research work targeted at invention of new pharmaceutical substances.
  • Assuring accuracy, objectivity and required efficiency of the results.

Structure

  • Chromatography and analytical groups perform quality control of medical products, pharmaceutical substances, excipients (among them HPLC and GC methods); develop method analysis of new medical products; validate analytical methods.
  • Employees of the standardization group prepare registration dossier (including CTD format), develop in-house standards and procedures, and support quality system.
  • Technology-and-testing laboratory develops composition and technology of new medical products products, validate technological processes, carries out activity on scaling-up.

R&D Laboratory in cooperation with R&D Department perform the following science-research and design-and-experimental activities::

  • Development of composition and technology of new medical products and their further launching into manufacture.
  • Transfer of medical products technology to commercial scale.
  • Medical products, pharmaceuticals and excipients testing.
  • Stability testing of medical products and pharmaceutical substances.
  • Development and validation of method analysis of medical products.
  • Preparation of registration documents for medical products and pharmaceutical substances.
  • Research activities focused on new pharmaceutical products development.
  • Support of registration of medicines and pharmaceutical substances and clinical trial authorization.

R&D’s background

R&D Laboratory has experience in pharmaceutical development of the below mentioned pharmaceutical forms:

  • Tablets;
  • Coated tablets;
  • Dispersible tablets;
  • Modified release tablets;
  • Capsules;
  • Suppositories;
  • Syrups;
  • Emulsions;
  • Powders/granules for suspension/oral liquids;
  • Oral gels.

Execution Timeframes

  • Development of quality control methods of medical products quality control – 60 days;
  • Methods of development of medicines quality control – 60 days;
  • Manufacturing and quality control of pilot batches s of medicines – 120 days;
  • Organization of industrial production and technical documents preparation – 150 days
  • Timeframes of stability investigation are set in accordance with ICH Q1 recommendations.

R&D Laboratory provides high quality implementation of the services due to availability of:

  • Rated experimental and industrial facilities;
  • Full package of up-to-date technological and analytical equipment;
  • Efficient staff with rich experience in development and quality control of medical products.

Equipment

In order to accomplish the above mentioned tasks R&D Laboratory applies technological and analytical equipment produced by the leading global manufacturers. Chromatography and analytical group develops and validate analytical methods for excipients, pharmaceutical forms under development and active pharmaceutical ingredients in compliance with CPMP/ICH/381/95, European Pharmacopoeia and USP. In order to conduct necessary testing properly. Chromatography group is equipped with up-to-date analytical devices (HPLC, gas-liquid chromatography, dissolution test machines etc.) produced by:
Shimadzu (Japan); Waters, Agilent Technologies, Millipore (USA); Pharma Test (Germany).

HPLC devices are equipped with modern multi-channel gradient pumps, autosamplers, analytical thermostat columns and various types of detectors. Flexible modular systems render possibility to develop, validate and reconstruct methods of diverse complexity levels.

EQUIPMENT AND DESCRIPTION
HPLC system Shimadzu LC-20 Promince equipped with embedded degassing agent, gradient four-channel pump, thermostatic autosampler, column thermostat, photodiode array detector, refractive index detector, light-diffusing detector. Used when tests, regarding Eur. Ph. 2.2.29, USP <621> and other regulatory documents are carried out.
equipped with embedded degassing agent, gradient four-channel pump, thermostatic autosampler, column thermostat, spectrophotometric detector. Used when tests, regarding Eur. Ph. 2.2.29, USP <621> and other regulatory documents are carried out.
HPLC system Waters Alliance equipped with embedded degassing agent, gradient two-channel pump, autosampler, column thermostat, spectrophotometric detector. Used when tests, regarding Eur. Ph. 2.2.29, USP <621> and other regulatory documents are carried out..
Gas-liquid chromatography Agilent 7820A equipped with liquid sample injector, headspace analysis autosampler. Used when tests, regarding Eur. Ph. 2.2.28, USP <621> and other regulatory documents are carried out.
Dissolution system PT DT70 Used when tests, regarding Eur. Ph. 2.9.3, USP <711> and other regulatory documents are carried out.
Spectrofluorometer Fliuorat-02 Panorama Used when spectrofluorometrical tests, regarding Eur. Ph. 2.9.3, USP <711> and other regulatory documents are carried out.
Polarimeter AP300 Used when tests, regarding Eur. Ph. 2.2.7, USP <781> and other regulatory documents are carried out.
Spectophotometer SPEKS SSP Used when tests, regarding Eur. Ph. 2.2.25, USP <851> and other regulatory documents are carried out.
ERWEKA Test Machine for fragility/friability testing of solid dosage forms Used when tests, regarding Eur. Ph. 2.9.7, USP <1216> and other regulatory documents are carried out.
ERWEKA Test Machine for hardness testing of solid dosage forms Used when tests, regarding Eur. Ph. 2.9.8, USP <1217> and other regulatory documents are carried out.
ERWEKA Test Machine for disintegrating testing of tablets and capsules Used when tests, regarding Eur. Ph. 2.9.1, USP <701> and other regulatory documents are carried out.
PharmaTest Test Machine for disintegrating testing of suppositories and pessary tablets Used when tests, regarding Eur. Ph. 2.9.2, USP <2040> and other regulatory documents are carried out.
Granulate forming machine (pelletyzer) GCS 200/40 equipped with water cooling system to prevent devices nodes from heating up while in operation. Produces pellets of adjustable length via pushing wet mass through dies holes.
Machine for production and packing of suppositories (Suppository Machine) VR- consists of dosing node and refrigerator store UR-2. Dispenses suppository mass into blister card and freezes suppositories in the refrigerator.
Machine for sealing, coding and clipping of suppositories VR-3 seals refrigerated suppositories, writes their serial numbers and cuts up suppository strip to the desired pieces.
Testing machine for packed density defining PT-TD defines apparent volume and tapping density of powders and granules in accordance with USP, EP.
SD-1 Multifunctional laboratory aggregate for solid forms forms consists of drive unit, reducing socket for some functional bolts and various functional bolts for mixing powder with binding liquid, swinging granulator, mixer unit for powders and powdering, coater, tableting press.
Swinging sieve EMS 8 sieves powder material.
Rotary tableting press ZP-8 8-tool tableting press produces tablets of any shape on semi commercial level. Equipped with feeding unit, electromotor, tablet dust remover.

Scaling and technology transfer is possible due to the OJSC AVVA RUS’s production capacity and also can be moved to the working space of customer with further consultative support by R&D’s personnel

Standardization group carries out investigation of medical products and pharmaceutical substances stability in different climate conditions (stress-testing, accelerated tests of stability, long-term research, photo-stress study) in accordance with ICH Q1. Main thermal modes are listed below:

t, °СRelative degree of humidity, %Expiry datePlace of storage
25 ± 2 60 ± 2 Before expiry date
(long-term testing)
Arbitrage storage stockroom
30 ± 2 65 ± 2 12 months (midterm testing) Climate chamber YP-720SDP
40 ± 2 75 ± 2 6 months
(accelerated testing)
Climate chamber KBF-240
Stability testing in the temperature ranges 0 ºС-70 ºС and humidity ranges 10%-80%, stress-testing, photo-stress study. Climate chamber KBF P 240

Equipment capacity allows diversifying conditions depending on customer’s demand of climate conditions.


Climate chamber YP-720SDP

Climate chamber YP-720SDP is used for storage of medical products at set temperature and humidity.

TEMPERATURE CHARACTERISTICS
Temperature range without humidity 0 ÷ +100 °С
Temperature range with humidity 0 ÷ +90 °С
Temperature shift without humidity ± 0,5 °С
Deviation of relative humidity ± 3 %
  • Climate chamber has microbased control humidification and dehydration systems, the chamber fully responds to the set FS requirements of stability and operating life.
  • The chamber is equipped with multi-functional microprocessing screen controller with two channels: one for temperature with accuracy measurement of temperature to 0.1 ºС, and another for humidity with accuracy measurement of relative humidity to 0.1 %.
  • The screen programmed controller TH300 enables to reflect diagrams on temperature and humidity change over the recent 60 hours of the chamber operation, and to reflect the current temperature and humidity in the chamber.
  • In addition the chamber is equipped with air temperature limiter for emergency cutoff of air heating in the chamber, and with water temperature limiter in the steam bath for prevention of water boiling.

Climate chamber KBF-240

Climate chamber KBF-240 is used for storage of medical products at set temperature and humidity.

ТЕМПЕРАТУРНЫЕ ХАРАКТЕРИСТИКИ
Temperature range without humidity 0 ÷ +100 °С
Temperature range with humidity 0 ÷ +90 °С
Temperature shift without humidity ± 0,5 °С
Deviation of relative humidity ± 3 %
  • Climate chamber has microbased control humidification and dehydration systems, the chamber fully responds to the set FS requirements of stability and operating life.
  • The chamber is equipped with multi-functional microprocessing screen controller with two channels: one for temperature with accuracy measurement of temperature to 0.1 ºС, and another for humidity with accuracy measurement of relative humidity to 0.1 %.
  • The screen programmed controller TH300 enables to reflect diagrams on temperature and humidity change over the recent 60 hours of the chamber operation, and to reflect the current temperature and humidity in the chamber.
  • In addition the chamber is equipped with air temperature limiter for emergency cutoff of air heating in the chamber, and with water temperature limiter in the steam bath for prevention of water boiling.

Personnel

Total number of laboratory employees constitutes 30 people, 27 of them have specialized university degrees. Personnel are experienced in the fields of manufacturing, medical products quality control and analytical chemistry.

R&D’s personnel take annual professional course at the leading education centers of Moscow, Saints-Petersburg, Yekaterinburg and other cities and upgrade their professional skills due to regular in-house training in compliance with GMP.

Our partners

We provide contract services on pharmaceutical development for the companies like CJSC R-Farm, Nearmedic Plus Ltd., N.C. Pharmaceuticals Ltd., Functional Products Ltd., Teva Ltd. etc.